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褥瘡会誌(Jpn褥瘡会誌(2016) J PU),18(4):455〜544,2016 ― 455 ―

JSPU Guidelines for the Prevention and Management of Pressure Ulcers(4th Ed.)

The Japanese Societyof Pressure Ulcers Guideline Revision Committee

Representative : Takafumi Kadono1) Committee Members : Katsunori Furuta2), Yayoi Nagai3), Hiroyuki Kanoh4) Yusuke Sekine5), Yasuhiro Noda6), Fumihiro Mizokami2) Hitomi Kataoka7), Hiromi Nakagawa8), Katsumi Tanaka9) Takehiro Daian10), Yuta Kurashige11), Gojiro Nakagami12) Noboru Makabe13), Rie Sekine14), Miyuki Takasaki15) Kenji Yoshino16), Takayuki Endo17), Masami Hidaka18) Noriaki Maeshige19), Kouhei Kubota20), Tomoyuki Morita21) Mayumi Okuwa22), Masako Miyajima23), Madoka Noguchi24) Sachiko Kinoshita25), Masayo Sobue26), Yuko Matsui25) Yoko Murooka27), Yoko Ishida8) Advisers : Junko Sugama22), Takao Tachibana28) Vice Chairperson : Yuji Inoue29) Committee Chairperson : Hironobu Ihn30)

1)Universityof Tokyo,Facultyof Medicine, Department of Dermatology;2)National Center for Geriatrics Gerontology, Department of Pharmacy; 3)Medical Security and Safety Management Center Gunma University Hospital; 4 ) Department of Dermatology, Gifu University Graduate School of Medicine; 5 ) Department of Pharmacy, Tokyo Medical University Hospital; 6)Kinjo Gakuin University, College of Pharmacy; 7)Yamagata UniversitySchool of Medicine, Department of Nursing; 8)Yokohama Soei UniversityFacultyof Nursing; 9) Department of Plastic and Reconstructive Surgery, Unit of Translational Medicine, Graduate School of Biomedical Sciences, Nagasaki University; 10 ) Department of Plastic and Reconstructive Surgery, Miyazaki Konan Hospital; 11 ) Department of Dermatology, Tokai University School of Medicine; 12 ) Department of Gerontological Nursing/Wound Care Management, Graduate School of Medicine, The Universityof Tokyo;13) Kansai Electric Power Hospital , Center for Metabolism and Clinical Nutrition; 14)The Universityof Tokyo Hospital, Department of Clinical Nutrition Therapy; 15)Tsurumakionsen Hospital, Division of Nutrition Support; 16)Faculty of Human Life Science, Mimasaka University; 17)Higashisumiyoshi Morimoto Hospital, Department of Dietetics; 18)Hyogo University of Health Sciences, School of Rehabilitation, Department of Physical Therapy; 19)Kobe UniversityGraduate School of Health Sciences, Department of Rehabilitation Science; 20)Saitama Rehabilitation Center; 21)Kanagawa Rehabilitation Hospital, Department of Physical Therapy; 22)Department of Health Sciences, Institute of Medical, Pahrmaceutical and Health Sciences, Kanazawa University; 23 ) Wakayama Medical University, School of Health and Nursing Science; 24)Kobe University Hospital, Nursing Department; 25)Kanazawa Medical UniversitySchool of Nursing; 26)JA Aichi Konan Kosei Hospital; 27)School of Nursing and Nutrition, Shukutoku University; 28)Osaka Red Cross Hospital, Department of Dermatology; 29) Department of Dermatology,Kumamoto CityHospital; 30)Department of Dermatologyand Plastic Surgery, Facultyof Life Sciences, Kumamoto University

Correspondence : Takafumi Kadono Department of Dermatology, Faculty of Medicine University of Tokyo 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan E-mail : [email protected]

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Abstract

The Japanese Societyof Pressure Ulcers(JSPU)has compiled an English version of the updated fourth edition of the Guidelines for the Prevention and Management of Pressure Ulcers. The guidelines set forth here include a collection and discussion of medical issues specific to Japan as well as new evidence from research conducted abroad. Clinical questions (CQs)and their analyses were organized in the order of treatment followed by prevention : topical agents, dressings, surgical intervention, general management, rehabilitation, risk assessment, skin assessment, skin care, repositioning, support surfaces, patient education, outcome management, and QOL/pain. Each recommendation was assigned one of five ratings(A, B, C1, C2 and D). A CQ discussing the so-calledTwrap therapyUused in Japan was also included. As a new approach, algorithms and flow-charts were prepared for each topic. The present guidelines provide the best and most comprehensive recommendations currentlyavailable to health care professionals worldwide.

prevention of this condition. Crucially, the recom- Introduction mendations offered in the guidelines have been 1.Background formulated with a view to addressing the special In 2005, the Japanese Societyof Pressure Ulcers needs of such health care professionals in their publishedTGuidelines for Local Treatment of Press- respective clinical settings and to helping them to ure UlcersU1) and followed this in 2009 bya revised make the best clinical decisions possible in their edition,TGuideline for Prevention and Management circumstances. of Pressure Ulcers2). After further revision in 2012, it It should be noted that while these guidelines aim to issuedT Guidelines for the Prevention and Manage- be comprehensive in their scope, theyare also ment of Pressure Ulcers(3rd ed.)3, 4). Major points of designed to maximize the expertise and experience of revision in the 3rd edition were ① the addition of new the individual health care professional and the Clinical Questions(CQs), ② supplementation of new resources available in each particular clinical setting evidence and presentation of the ratings, recom- in order to achieve the best possible outcome for mendations, and analyses in consideration of condi- individual patients and their familyor caretakers. By tions of clinical practice, ③ inclusion of CQs about means of these new guidelines, we hope to set a new Twrap therapyUspecific to Japan, ④ arrangement of and higher standard for pressure ulcer care in Japan CQs in the order of those concerning treatment and through improvements in the qualityof pressure those concerning care, and ⑤ preparation of algor- ulcer prevention and management, as well as in the ithms and flow charts. The present guidelines were better guidance which health care professionals will compiled primarilybythe Academic Education be able to offer patients and their families. Committee in a journal-style format also by collecting 3.Guideline Developers evidence obtained after the previous revision. In The present guidelines were prepared bythe Western countries, the NPUAP/EPUAP Guidelines5) Guidelines Revision Committee( Academic Educa- were published in 2009, and a revised edition were tion Committee)appointed bythe Japanese Society released in 20146), but, in the present guidelines, we of Pressure Ulcers(see list of authors). In the present collected evidence and determined and the levels/de- guidelines, the aims and contents adhere fundamental- grees of recommendation on the basis of the past lyto those of theTGuidelines for Local Treatment for revised editions1−4), in principle. Also, the guidelines Pressure UlcersU(first edition, 2005)1), theTGuide- set forth here were designed with due consideration lines for Prevention and Management of Pressure of medical issues specific to Japan. UlcersU(second edition, 2009)2), and theTGuidelines 2.Purpose and Scope for Prevention and Management of Pressure UlcersU The purpose of the present guidelines is to provide (third edition)3, 4). A list of those who participated in the best and most comprehensive recommendations the development of these past editions is presented possible, based on the most recent and reliable below. evidence, for the treatment of pressure ulcers for the First Edition(2005)1) benefit of the full range of health care professionals Yoshiki Miyachi( Chairperson ), Hiromi Sanada who are in anywayinvolved in the management and (Vice Chairperson), Junko Sugama, Takao Tachibana,

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Motonari Fukui, Katsunori Furuta, Toshiko Kaitani, tized ; however, for the Clinical Questions dealing with Keiko Tokunaga, Toshio Nakajo, Yoshio Mino, Takehi- nursing, evidence focusing on QOL as the chief ko Oura, Hiroaki Oka, Masahiro Tachi, Toru Fujii, outcome measure was also used. Animal studies and Takahiko Moriguchi, Takeo Nakayama, Takashi basic research was not included. As a rule, medical Nagase, Masaharu Sugimoto, Masami Hidaka. equipment, materials, topical , and dres- Second Edition(2009)2) sings mentioned in the present guidelines are Masutaka Furue( Chairperson ), Hiromi Sanada obtainable in Japan. If anyare unavailable in Japan, ( Vice Chairperson ), Takao Tachibana, Takafumi this fact has been dulynoted. Kadono, Toshiko Kaitani, Hiroaki Oka, Takashi 2)Evidence level and recommendation rating Nagase, Masahiro Tachi, Takeo Nakayama Makiko The criteria for determining the evidence levels and Tanaka, Mayumi Okuwa, Junko Sugama, Noriko ratings for recommendation of the present guidelines Matsui, Yukie Kitayama, Keiko Tokunaga, Kayoko were formulated with reference to the Japanese Adachi, Shingo Okada, Masami Hidaka, Hideyuki Guidelines for the Management of Stroke 2009,7)the Hirose, Chizuko Konya. Minds Reference Guide 2007 for Writing Clinical Third Edition(2012)3, 4) Practice Guidelines,8)and Clinical Practice Guidelines Ryoji Tsuboi( Chairperson ), Makiko Tanaka for Skin Cancer9). (Vice Chairperson), Takafumi Kadono, Yayoi Nagai, (1)Classification of Evidence Levels Katsunori Furuta, Yasuhiro Noda, Yusuke Sekine, Ⅰ:Systematic reviews/meta-analyses Toshiko Kaitani, Hitomi Kataoka, Hiromi Nakagawa, ⅰ)Randomized controlled trials only Taku Iwamoto, Masakazu Kurita, Mikio Kinoshita, ⅱ )Randomized controlled trials, cohort stu- Yuta Kurashige, Gojiro Nakagami, Shoko Kakizaki, dies, case-control studies Masami Hidaka, Hideyuki Hirose, Masaharu Sugimo- ⅲ)Sources not including ⅰ)and ⅱ) to, Masako Miyajima, Madoka Noguchi, Mayumi Ⅱ:Randomized controlled trials Okuwa, Mihoko Ishizawa, Yukiko Kinoshita, Masayo Ⅲ:Non-randomized controlled trials Sobue, Yoko Murooka, Yuko Matsui, Tomoko Ohura, (Including historical controlled trials,* and self- Chizuko Konya, Shigeru Ichioka, Junko Sugama, controlled studies) Hideko Tanaka, Kayoko Adachi, Takeo Nakayama, Ⅳ:Analytical epidemiological research(in cohort Yoshiki Miyachi studies and case-control studies) 4.Method (Includes retrospective cohort studies, historic- 1)Sources of Evidence al controlled studies, **time series analyses, self- The databases used to assemble relevant informa- controlled studies) tion were MEDLINE( Pubmed ), Ichushi online Ⅴ:Descriptive studies( case reports and case database, CINAHL, and ALL EBM Reviews which series) include the Cochrane Database Systematic Reviews, (Including non-controlled intervention studies ACP Journal Club, Database of Abstracts of Reviews and cross-sectional studies) of Effect(DARE)and Cochrane Central Register of Ⅵ:Expert opinion of specialist committees or Controlled Trials( CCTR ). The information was endive-duals. Not based on patient data. sourced from various other relevant guidelines, as The evidence levels of each guideline used to well as data assembled byindividual contributors. determine the recommendation ratings have not been This information was assembled from January, 1980 described. to June, 2014. Systematic reviews and clinical trials, *An historical controlled trial is a form of interven- especiallyrandomized clinical trials, were prioritized. tion studydone in order to test the efficacyof a new When these sources were unavailable, observational form of treatment, and requires approval bythe ethics studies such as cohort studies and case-control studies committee of the relevant institution before it is were collected. In the event that the latter were performed. Unlike the randomized controlled studyin unavailable, the range of acceptable sources was which subjects are divided into a randomized expanded to include case series. As a rule, evidence intervention group and the control group, and the dealing chieflywith the outcome index was priori- outcomes for each group are compared, the historical

―G−3― ― 458 ― controlled trial examines cases which were observed lines published outside Japan were referred to at some time in the past for a comparison of their frequentlyfor their value in helping us to establish the treatment outcomes with those of the intervention criteria for determining the ratings presented here. group receiving a new treatment. In some of the CQs for which there was a paucityof **An historical controlled study, like the historical evidence relating directlyto pressure ulcers, the controlled trial, examines cases which were observed range of sources was broadened to include those at some time in the past for comparison with an dealing with injuries and cutaneous ulcers as well. In intervention group receiving a new form of treatment. such cases, however, the strength of the recommenda- However, it differs from the historical controlled trail tion was accordinglylowered. in that it is a form of observational studyconducted as The endorsement of the guideline committee was a part of dailyconsultation rather than an intervention required for inclusion into the guidelines of treat- studyconducted for the purposes of testing a new ments which earned the rating C1, insofar as such form of treatment. treatments were deemed valuable for clinical practice, (2)Recommendation Ratings even if theylacked sufficient evidence. A:Stronglyrecommended because supported 5.Funding and Conflict of Interest byadequate evidence *. Funding for the compilation of the present guide- B:Recommended because supported bysome lines was provided entirelybythe Japanese Societyof evidence Pressure Ulcers and does not derive in anypart from C1:Maybe considered because supported by other organizations or industries. Further, the content limited evidence of each rating was decided bya vote of the guideline C2:Not recommended because no supporting revision committee. If anymember of the guideline evidence found revision committee was found to have a conflict of D:Not recommended because of invalid or interest in connection with anyitem, he or she was possiblyharmful findings asked to abstain from voting on the item in question. k* Evidence lis defined as the findings of clinical 6.Definition of Terms trials and epidemiological research. The definition of the terms used in the present (3)Criteria for Determining Recommendation guidelines conforms to that laid down bythe Rating Technical Definitions Committee of the Japanese The criteria for determining the recommendation Societyof Pressure Ulcers. A separate set of terms ratings have been carried over from the previous was prepared herein for use with the DESIGN and editions1, 2)A rating of A therefore requires one Level DESIGN-R scales published bythe Japanese Societyof Ⅰ or high qualityLevelⅡ source of evidentiary Pressure Ulcers to reflect the unique historyand support. However, anysystematicreview not dealing development of this project. exclusivelywith randomized controlled trials 7.Peer Reviews and Plans for Future Revisions weakens the strength of the rating. A rating of B The present guidelines were made possible bythe requires at least one source of inferior qualityLevelⅡ contributions and peer reviews of numerous members or high qualityLevelⅢ evidence, or failing this, an of the guideline revision committee and based on the extremelyhigh qualitysource of LevelⅣ evidence. unanimous approval of all of the members, arrived at However, randomized controlled trials with small through the process of debate and discussion. During numbers of subjects and industrysponsorship earn a this process, feedback from other members of the lower rating. A rating of C1 requires an inferior Level Japanese Societyof Pressure Ulcers was sought at Ⅱ−Ⅳ, or a high qualityLevelⅤ, source of evidence, two symposia held by the Society. Members were also or alternativelya LevelⅥ evidence source endorsed encouraged to submit their opinions via the Societyls bythe committee. A rating of C2 is based on sources website. lacking valid evidence, or providing invalid evidence, The present guidelines will be revised under the while a rating of D is based on high-qualitysources leadership of the Academic Education Committee of with invalid or harmful findings. the Japanese Societyof Pressure Ulcers at intervals of The commentaryand recommendations in guide- everyseveral years.

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exudate, size, inflammation/infection, granulation, and References necrosis. 1)Japanese Societyof Pressure Ulcers : Guideline for Although scales with similar purposes, such as the local treatment of pressure ulcers, Shorinsha, Tokyo, Bates-Jansenls Pressure Sore Status Tool(PSST)1), 2005. NPUAPls Pressure Ulcer Scale for Healing(PUSH)2), 2)Japanese Societyof Pressure Ulcers : Guideline for and Ohurals Assessment of Pressure Ulcer-Healing Prevention and Management of pressure ulcers, Process(PUHP)3)have alreadybeen put to practical Shorinsha, Tokyo, 2009. use, each scale presents some difficulties which 3)The Japanese Societyof Pressure Ulcers Guideline DESIGN attempts to address. DESIGN4) was de- Revision Committee : JSPU Guidelines for the Preven- veloped on the basis of expert opinion and incorpo- tion and Management of Pressure Ulcers(3rd Ed.). rates four features, namely, its ability to : 1)quantify Jpn J PU,14(2):165-226, 2012. severityof pressure ulcers and the healing process 2) 4)The Japanese Societyof Pressure Ulcers Guideline monitor intervention in term of each of the para- Revision Committee : JSPU Guidelines for the Preven- meters mentioned above and changes in wound tion and Management of Pressure Ulcers(3rd Ed.). surface 3)provide a standard and convenient tool for Jpn J PU,16(1):12-90, 2014. use in the clinical setting and 4)be compatible with 5)National Pressure Ulcer AdvisoryPanel and Euro- international standards for care and intervention. pean Pressure Ulcer AdvisoryPanel : Prevention and In order for such a scale to be readilyaccepted, it treatment of pressure ulcers : clinical practice guide- was necessaryto test its inter-rater reliability,content line. National Pressure Ulcer AdvisoryPanel, validity, construct validity, concurrent validity and Washington DC, 2009. predictive validity. When DESIGN was developed, 6)National Pressure Ulcer AdvisoryPanel, European testing of its predictive validitywas omitted 5−8) with Pressure Ulcer AdvisoryPanel, Pan Pacific Pressure the result that questions were raised as to its fitness to InjuryAlliance : Prevention and treatment of press- quantitate the severityof patientslconditions, ure ulcers : clinical practice guideline. National although there was no question as to its abilityto Pressure Ulcer AdvisoryPanel, Washington DC, 2014. assess changes in the condition of individual cases. 7)The Minds Committee on Clinical Practice Guide- Thus with a view to realizing a scale which would lines : The Minds Reference Guide 2007 for Writing enable the health care professional not onlyto Clinical Practice Guidelines, IGAKU-SHOIN Ltd., evaluate pressure ulcer progression but also predict Tokyo, 2007. its severityreliablyand accurately,revision of the 8)The Joint Committee on Guidelines for the Manage- scale was begun in 2005. Since DESIGN had already ment of Stroke : Japanese Guidelines for the Manage- been widelyused clinically,some preconditions were ment of Stroke 2009, KYOWA KIKAKU Ltd., Tokyo, called for, that is, the seven parameters measured by 2009. DESIGN-P( P indicatesk pocket lork undermin- 9)Saida T, Manabe M, Takenouchi T, et al : The ingl)were to remain unaltered. In order to make this Committee on Clinical Practice Guidelines for Skin feasible, first, a large-scale(2598 cases)retrospective Cancer : Clinical Practice Guidelines for Skin Cancer. case-series studywas conducted, followed bya Jpn J Dermatol, 117(12):1855-1925, 2007. prospective case-series studywith 1003 cases. For each study, a large number of subjects were enrolled From DESIGN to DESIGN-R in both the healing and non-healing groups using the In 2002, the Academic Education Committee of the Cox hazard analysis. Japanese Societyof Pressure Ulcers announced the As a result, the parameters were ranked according DESIGN(Depth, Exudate, Size, Inflammation/Infec- to their weight as follows: pocket, size, inflammation/ tion, Granulation and Necrosis )scale in answer to infection, granulation tissue, exudates, and necrosis. A needs : namely, first, the need for a means of assessing positive correlation was found among these para- pressure ulcers according to severity, and second, for meters, excluding inflammation/infection, where a a means of quantifying aspects of the treatment higher degree of severitywas accompanied bya process in terms of the wound parameters of depth, higher weighting of the individual parameters9−11).In

―G−5― ― 460 ― terms of background information, a comparatively Care, 13(1):13-18, 2004. large number of aged persons were enrolled. The 8)Matsui Y, Sugama J, Sanada H, et al : Predictive facilities examined were mostlyuniversityhospitals validityand weighting of D-E-S-I-G- N : A wound and the number of home care settings was small. healing progression tool. Jpn JPU, 7(1):67-75, 2005. However, when Cox hazard analysis was conducted 9)Tachibana T, Matsui Y, Sugama J, et al : The Report using these factors as adjusted variables, there was no of arts and sciences Board of Education- Revision of change in weighting, demonstrating that the bias in DESIGN-. Jpn JPU, 10(4):586-596, 2008. terms of the age and types of institution had no effect 10)Matsui Y, Furue M, Sanada H, et al : Development of on the scalels weighting9). the DESIGN-R with an observational study: an In order to make the statisticallycalculated absolute evaluation tool for monitoring pressure ulcer weightings more convenient for clinical use, the wound healing. Wound Repair Regen, 19(3):309- weighted values were simplified to be multiples of 3. 315, 2011. Comparison of the weightings before and after their 11)Sanada H, Iizaka S, Matsui Y, et al : Scientific simplification showed that correlation was high at 0. Education Committee of the Japanese Societyof 991 while also affirming that the procedure did not Pressure Ulcers. Clinical wound assessment using influence severityevaluation. Finally,the depth DESIGN-R total score can predict pressure ulcer parameter values were found to be unrelated to the healing : pooled analysis from two multicenter cohort weighted values but rather to reflect the status of the studies. Wound Repair Regen, 19(5):559-567, 2011. pressure ulcer. For this reason it was not included in Algorithm for Prevention and Management of the total score. In order to draw attention to the fact Pressure Ulcers that weighting had been added as a novel feature, the name of the scale was changed from DESIGN to The decision tree(Fig. 1)illustrates the process DESIGN-R withkRlstanding forkrating.lIn 2008 bywhich procedures for the prevention and/or DESIGN-R was published and has since been widely management of pressure ulcers in the target popula- used throughout the Japan as a pressure ulcer tion maybe designed. assessment scale with acceptable predictive validity. First, subjects are given a general physical ex- amination and their risk of developing pressure ulcers References is assessed. In cases in which there is no risk of 1)Bates-Jansen BM, Vredevoe DL, Brecht M : Reliability developing pressure ulcers, the condition of the of the pressure sore status tool. Decubitus, 5(6):20- subject continues to be monitored regularly. In cases 28, 1992. where there is risk of developing pressure ulcers, local 2)National Pressure Ulcer AdvisoryPanel : Pressure inspection of the skin is performed and the presence ulcer scale for healing(PUSH), 1998. or absence of pressure ulcers is confirmed. In the 3)Ohura T : Practical Guide for Pressure Ulcer Care. absence of pressure ulcers, a suitable regimen of Shorinsha Inc, Tokyo, 102-109, 2001. preventive care( Fig. 6 )or general care( Fig. 4 ) 4)Ohura T, Miyachi Y, Sanada H, et al : The pressure maybe designed and implemented. If a pressure ulcer ulcers state rating system : How to put and usage of is found, Fig. 7 or 5 maybe consulted in order to the DESIGN. Shorinsha Inc, Tokyo, 6-9, 2003. design an effective care regimen for treatment. Fig. 2 5)Moriguchi T, Miyachi Y, Sanada H, et al : DESIGN-A and 3 maybe also consulted in order to determine the new assessment tool for the classification and the most suitable treatment modality, such as conserva- healing process in pressure ulcers-. Jpn JPU, 4(1): tive treatment or surgical intervention. Following 1-7, 2002. successful implementation of this phase of patient 6)Sanada H, Tokunaga K, Miyachi Y, et al : DESIGN- care, risk of further occurrence(or recurrence)of Reliabilityof the new pressure ulcer assessment tool-. pressure ulcers, the patientls general physical condi- Jpn JPU, 4(1):8-12, 2002. tion, and state of existing pressure ulcers maybe 7)Sanada H, Moriguchi T, Miyachi Y, et al : Reliability assessed as appropriate. and validityof DESIGN, a tool for that classifies pressure ulcer severityand monitors healing. Wound

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Fig. 1 Algorithm illustrating options for prevention and management of pressure ulcers

recommendations are shown in Table 1-13. Table of Clinical Questions(CQ)s and Accompanying Recommendations

Clinical questions(CQ)s and their accompanying

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Table 1 Topical agents

Clinical Question Rating Recommendation External medications with oleaginous bases with a high degree of efficacy in protecting wound surfaces such as those of zinc oxide, dimethyl Which external medications are recom- CQ1.1 C1 isopropylazulene, and white petrolatum and those with an emulsion base mended to treat acute pressure ulcers? with a high moisture content(O/W)such as silver sulfadiazine mayalso be considered. Dailyobservation of the wound must not be neglected, and external Which external medications are indicated medications with oleaginous bases with a high degree of efficacyin CQ1.2 C1 when deep tissue injury(DTI)is suspected? protecting the wound surface such as zinc oxide and dimethyl isopropyla- zulene mayalso be used. It is important to protect the wound surface, and external medications Which external medications are recom- with oleaginous bases with a high degree of efficacyin protecting the CQ1.3 mended for cases involving redness/pur- C1 wound surface such as zinc oxide and dimethyl isopropylazulene may also pura? be used. External medications with oleaginous bases with a high degree of efficacy Which external medications are recom- CQ1.4 C1 in protecting the wound surface such as zinc oxide and dimethyl mended for cases involving blistering? isopropylazulene may also be used. Zinc oxide or dimethyl isopropylazulene may be used. Alprostadil alfadex, Which external medications are recom- CQ1.5 C1 bucladesine sodium, or lysozyme hydrochloride may also be used to mended to treat erosions and shallow ulcers? promote re-epithelialization. While external medications do not relieve pain of the wound, theycan mitigate pain bymaintaining the wound surface in an appropriate moist Are external medications recommended if environment. External medications of drugs such as dimethyl isopropyla- CQ1.6 C1 pain accompanies the pressure ulcer? zulene with an oleaginous base with a high wound-surface-protecting effect or those of drugs such as silver sulfadiazone and tretinoin tocoferil in an emulsion base with a high moisture content(O/W)mayalso be used. Cadexomer- and povidone-iodine sugar are both highlyabsorbant B Which external medications are recom- and are recommended for pressure ulcers with excessive exudate. CQ1.7 mended for pressure ulcers with excessive exudate? C1 and iodine ointment maybe considered.

Which external medications are recom- External medications of silver sulfadiazine and tretinoin tocoferil in an CQ1.8 mended in pressure ulcers with minimal C1 emulsion base( O/W )with a high moisture content maybe used for exudate? infected and uninfected wounds, respectively. Cleanse the pressure ulcer using isotonic saline or tap water in sufficient CQ1.9 How should a pressure ulcer be cleaned? C1 quantities to reduce the microbial count on the wound surface. Wound cleansing is usuallyadequate to prevent infection. However, if the CQ1.10 How should pressure ulcers be disinfected? C1 wound is clearlyinfected or if there is excessive exudate or pus, the wound maybe disinfected using prior to cleansing. Cadexomer-iodine, silver sulfadiazine, and povidone-iodine sugar are B Which external medications are recom- recommended for their abilityto control infections. CQ1.11 mended for pressure ulcers accompanied by Fradiomycin sulfate-crystalline trypsin, povidone-iodine, iodine ointment, infection and inflammation? C1 and iodoform gauze maybe considered. Which external medications are recom- Topical medications with an anti-microbial properties, such as cadexomer- mended when delayed wound healing due to CQ1.12 C1 iodine ointment, povidone-iodine sugar, iodine ointment, or silver sulfa- critical colonization is suspected in the period diazine maybe used. of granulation tissue formation? Alcloxa, , tretinoin tocoferil and povidone-iodine sugar, all of Which external medications are recom- B mended to accelerate granulation formation which are known to accelerate granulation formation, are recommended. CQ1.13 in pressure ulcers with deficient granulation Alprostadil alfadex, bucladesine sodium, or lysozyme hydrochloride may C1 formation? be considered. Alcloxa, alprostadil alfadex, trafermin, bucladesine sodium, and povidone- B Which external medications are recom- iodine sugar are recommended. CQ1.14 mended for wound reduction in pressure Zinc oxides, dimethyl isopropylazulene, extract from hemolyzed blood of ulcers with sufficient granulation formation? C1 young calves, and lysozyme hydrochloride may be used. Which external medications are recom- Cadexomer-iodine, silver sulfadiazine, dextranomer, , povidone- CQ1.15 C1 mended if necrotic tissue is observed? iodine sugar or iodoform maybe considered. If the undermining is covered bynecrotic tissue, the wound surfaces Which external medications are recom- should first be cleaned. Also, if there is excessive exudate, povidone iodine- CQ1.16 C1 mended when undermining has occurred? sugar maybe used. If the amount of exudation is minimal, consider using trafermin or tretinoin tocoferil.

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Table 2 Dressings

Clinical Question Rating Recommendation Which dressings are recommended to In order to protect the wound surface while allowing dailymonitoring of the condition, CQ2.1 C1 treat acute pressure ulcers? transparent film dressings or dressings designed to treat dermal wounds maybe used. Which dressings are indicated in In order to protect the wound surface while allowing dailymonitoring of the condition, CQ2.2 pressure ulcers with suspected deep C1 either transparent film dressings or dressings designed to treat dermal wounds maybe tissue injury(DTI)? considered. Which dressings are recommended In order to protect the wound surface while allowing dailymonitoring of the condition, CQ2.3 for pressure ulcers involving red- C1 either transparent film dressings or dressings designed to treat dermal wounds maybe ness/purpura? considered. While leaving the blisters intact, consider using a transparent film dressing to protect the Which dressings are recommended CQ2.4 C1 wound surface. A dressing for dermal wounds that allows observation mayalso be for cases involving blistering? considered. A health insurance-covered hydrocolloid dressing used to treat dermal wounds is B recommended. A hydrocolloid dressing used to treat subcutaneous wounds is also an option, but is not covered byhealth insurance. Which dressings are recommended Health insurance-covered dressings designed to treat dermal wounds, such as hydrogel, CQ2.5 for treating erosions or shallow polyurethane foam sheets, alginate foam dressing, and chitin membrane may be ulcers? considered. Dressings designed to treat subcutaneous wounds, such as hydrogel, C1 hydropolymer, polyurethane foam, polyurethane foam/soft silicone, alginate, and chitin membrane can also be employed with equal effect, but are not covered by health insurance. Dressings cannot remove pain but can lessen it byprotecting the wound surface and maintaining a moist environment conducive to wound healing. When changing dressings, C1 perform adequate pain assessment and apply a hydrocolloid, polyurethane foam/soft Which dressings are recommended ® ® CQ2.6 silicone, Hydrofiber , Hydrofiber /hydrocolloid, chitin membrane, or hydrogel. for pressure ulcers involving pain? For mitigating pain during dressing change, alginate, polyurethane foam, polyurethane C1 foam/soft silicone, hydrocolloid, Hydrofiber®, and Hydrofiber®/hydrocolloid may also be used. However, when hydrocolloid is used on delicate skin, it must be removed carefully.

B Recommend using polyurethane foam dressings, which can absorb excess exudates. Which dressings are recommended in CQ2.7 pressure ulcers with excessive ex- Dressings normallyused for subcutaneous wounds as well as dressings used to treat deeper wounds involving muscle and bone, such as alginate/CMC, polyurethane foam/soft udate? C1 silicone dressings, alginate, alginate foam, chitin membrane, Hydrofiber®, Hydrofiber® /hydrocolloids, or hydropolymer dressings, may be applied.

Which dressings are recommended B Using a hydrocolloid dressing is recommended. CQ2.8 for pressure ulcers with minimal amounts of exudates? C1 Using a hydrogel may be considered.

Consider using topical agents to suppress infection. Alternatively, silver-containing C1 ® Which dressings are recommended Hydrofiber or alginate silver maybe used. CQ2.9 for infected and inflamed pressure Alginate is sometimes used to dress wounds with excessive exudates because of its ulcers? C2 superior absorptive ability, but cannot be recommended here due to its inability to suppress infection. Which dressing materials are recom- mended when delayed wound healing CQ2.10 C1 Consider using silver-containing Hydrofiber® or alginate silver. is suspected in the granulation period due to critical colonization? Which dressings are recommended Alginate silver, alginate, hydrocolloid, hydropolymer, polyurethane foam, polyurethane for promoting granulation tissue CQ2.11 C1 foam/soft silicone, chitin membrane, Hydrofiber®, and Hydrofiber®/hydrocolloids may be formation in pressure ulcers where it considered. is deficient?

® Which dressings are recommended to B Using silver-containing Hydrofiber , alginate silver, or alginate is recommended. promote the reduction of the size of CQ2.12 wounds with adequate/normal gra- Hydrocolloid, hydrogel, hydropolymer, polyurethane foam, polyurethane foam/soft ® ® nulation tissue formation? C1 silicone dressing, alginate foam, chitin membrane, Hydrofiber , Hydrofiber /hydrocol- loids, alginate/CMC are also options, depending on the amount of exudate present. Which dressings are recommended If surgical or topical agents capable of removing necrotic tissue are CQ 2.13 C1 when necrotic tissue is present? unavailable, hydrogel may be considered. If necrotic tissue is present within the undermining, first remove this through lavation. If Which dressings are recommended if CQ2.14 C1 the amount of exudate is excessive, consider using alginate, silver-containing Hydrofiber®, undermining is found? or alginate silver. Wrap dressings can be considered for use whenever medicallyapproved dressings are unavailable or difficult to obtain on a continual basis, such as in a home based medical care. However, use of the wrap dressing should be supervised bya physicianwith an adequate Is the so-calledkwrap dressingl CQ2.15 C1 knowledge of pressure ulcer care and onlyafter the patients and their familyhave been * effective in treating pressure ulcers? instructed in the procedure and given their consent. k* Wrap dressing lis a dressing technique of covering wounds with non-medically approved(unsterilized)and non-adhesive commerciallyavailable plastic wrap. ―G−9― ― 464 ―

Table 3 Surgical Intervention

Clinical Question Rating Recommendation Is surgical debridement indicated when signs Surgical debridement maybe conducted if there is evidence of pus, foul CQ3.1 of infection/inflammation of the pressure C1 odor, or osteomyelitis accompanying the infection. ulcer are present? Surgical debridement maybe considered when a clear line of demarcation C1 What is the optimal timing for the surgical between necrotic and healthytissue is visible. CQ3.2 debridement of necrotic tissue in pressure Surgical debridement is considered when preexisting infection has been ulcers? B brought under control. Is surgical incision or debridement recom- Surgical incision or debridement is recommended for treating undermin- CQ3.3 C1 mended if undermining is present? ing which fails to respond to more conservative treatments. Conservative treatments are the preferred option, but surgical debride- C1 ment maybe performed when infection/inflammatorysigns are under control. Surgical debridement maybe considered for patients with a D3 or D4 C1 CQ3.4 When is surgical debridement indicated? pressure ulcer. Surgical debridement maybe considered according to the location of the infected pressure ulcer, the volume and extent of the necrotic tissue, the C1 blood supplyto the surrounding tissue, condition of the wound margin, and the patientls level of pain tolerance. Reconstructive surgerymaybe considered for D3~D4 pressure ulcers that C1 do not respond to conservative treatments.

Surgical reconstruction maybe considered for ulcers showing a non- CQ3.5 When is reconstructive surgeryindicated? C1 advancing edge and scar formation.

Reconstructive flap surgeryfollowing sequestration maybe considered as C1 a therapeutic option for osteomyelitis in pressure ulcers. There are numerous options for reconstructive surgeryfor pressure Which reconstructive surgical procedure is ulcers, but insufficient evidence on the outcome of anyof these procedures. CQ3.6 considered especiallyeffective for pressure C1 For this reason, no single surgical procedure can be recommended as ulcers? applicable to all cases. What kind of physiotherapy is recommended Negative pressure wound therapy(NPWT)may be considered for the CQ3.7 for pressure ulcers with low amounts of C1 treatment of wounds following debridement of infectious or necrotic tissue. granulation tissue?

―G−10― 褥瘡会誌(2016) ― 465 ―

Table 4 General management

Clinical Question Rating Recommendation Conditions including congestive heart failure, pelvic fracture, C1 spinal cord injury, diabetes, cerebrovascular disease, and Which underlying medical conditions may CQ4.1 chronic obstructive pulmonarydisease maybe considered. entail the risk of leading to pressure ulcers? In the perioperative management, it is recommended to B consider diabetes in particular. What form of nutritional intervention is For patients suffering from protein-energymalnutrition CQ4.2 recommended for the prevention of press- B (PEM), using a enhanced energyand protein supplement after ure ulcers in malnourished patients? due consideration of anyunderlyingconditions is recommended. How should patients incapable of oral intake Required nutrition is supplied byenteral tube-feeding, but, if it CQ4.3 C1 of nutrition and hydration be fed? is impossible, parenteral feeding maybe employed. Preventive general In the absence of inflammation or dehydration, serum albumin C1 manage- levels maybe used. ment C1 Rate of weight loss maybe considered for use.

What indices can be used to assess the level C1 Consider using the rate(amount)of food intake as an index. CQ4.4 of malnutrition as a risk factor for pressure Mini Nutritional Assessment( MNA )or MNA®- Short Form ulcers? C1 (SF)maybe used with elderlypatients.

C1 CONUT(controlling nutritional status)maybe used.

C1 Consider using Subjective Global Assessment(SGA).

If physical examination findings or test results indicate When is the systemic administration of advancing cellulitis and osteomyelitis, necrotizing fasciitis, CQ4.5 antibiotics(antimicrobials)indicated in pa- C1 bacteremia, or sepsis, administering systemic antibiotics may be tients with an infected pressure ulcer? considered. If onlysymptomsof local infection are found, administration of systemic antibiotics need not be considered. Using empiric antibiotics promptlyto suspected pathogens Which antibiotics( antimicrobials )are re- common in clinical settings maybe considered. Reconsider CQ4.6 C1 commended for treating infection? using more specific antibiotics to pathogens byreferring the results of susceptibilitytesting. Which underlying conditions may pose a Malignant tumors and cardiovascular diseases maybe consi- CQ4.7 risk of prolonging the healing of pressure C1 dered as factors which mayprolong the healing of pressure ulcers? ulcers. Should a nutritional screening and assess- A nutritional screening and assessment and nutritional General CQ4.8 ment be performed for pressure ulcer C1 intervention maybe considered if required. manage- patients? ment after In order to ensure adequate energyfor healing of pressure occurrence B ulcers, recommend providing patients with 1.5 times the basal How much nutrition in general should be CQ4.9 energyexpenditure(BEE). provided to pressure ulcer patients? B Recommend providing additional protein as required.

The diet maybe supplemented with zinc, ascorbic acid, Should the diet of pressure ulcer patients be CQ4.10 C1 arginine, L-carnosine, n-3 fatty acids, collagen hydrolysate, etc. supplemented with anyspecific nutrients? in consideration of the disease. Should a registered dietician or multidisci- Participation bya registered dietician or multidisciplinary CQ4.11 plinarynutritional team participate in the C1 nutrition support team in the care of pressure ulcer patients care of pressure ulcer patients? maybe recommended. Should bodyweight be used as a means of Recommend using bodyweight as a means of assessing the CQ4.12 assessing the efficacyof nutritional supple- B effectiveness of nutritional supplementation if edema or mentation in pressure ulcer patients? dehydration can be ruled out.

―G−11― ― 466 ―

Table 5 Rehabilitation

Clinical Question Rating Recommendation Which factors account for pressure ulcer Risk For patients with a historyof pressure ulcers, vigilance is CQ5.1 development in chronic spinal cord injury B assessment recommended to prevent recurrence. patients? Which methods are effective for preventing Conducting rehabilitation while monitoring interface CQ5.2 pressure ulcer development in spinal cord C1 pressure maybe considered. injurypatients? A pressure-redistributing seat cushion for individuals What type of cushion should be used with B with spinal cord injuryis recommended to prevent CQ5.3 elderlypatients in a seated position to prevent pressure ulcer development while seated. pressure ulcers? C1 The use of a dynamic cushion may be evaluated.

Should limitations be set on the length of time Elderlyindividuals unable to reposition without assist- CQ5.4 in which the individual remains continuously B ance are recommended to limit the duration of continued seated? sitting. Repositioning every15 min is recommended for seated At what intervals should the seated individual Preventive CQ5.5 C1 individuals who are capable of changing their body be repositioned? care position without assistance. Should the individualls posture while seated be The alignment and balance of the seated individual ls CQ5.6 C1 considered? bodyshould be considered.

CQ5.7 Should donut-type devices be used? D Donut-type devices are not recommended.

What kind of physical modality can be used to CQ5.8 C1 Consider using electric stimulation therapy. treat muscular atrophy? What kind of therapeutic exercise can be used CQ5.9 C1 Consider using passive range of motion exercises. to treat joint contracture? Should tissue overlying bony prominences be Massaging areas covering bonyprominences is not CQ5.10 D massaged? recommended. Care after How can dailyuse of the wheelchair bypatients A suitable sitting posture, an appropriate support CQ5.11 C1 occurrence with shallow pressure ulcers be facilitated? cushion, and limitation on sitting time maybe considered. What kind of physical modality can be used for Hydrotherapyandpulsed lavage/suction maybe per- CQ5.12 C1 patients with infected pressure ulcers? formed. What kind of physical modality can be used for Consider hydrotherapy or pulsatile lavage with or CQ5.13 C1 pressure ulcers containing necrotic tissue? without suction. Conservative Implementing electrical stimulation therapyis recom- treatment B mended. What kind of physical modality can be used to CQ5.14 Near infrared therapy, ultrasonic therapy, or electro- promote wound reduction? magnetic therapymaybe considered. Also, during bed C1 rest, a vibrator maybe used in addition to a bodyweight dispersion mattress.

―G−12― 褥瘡会誌(2016) ― 467 ―

Table 6 Risk assessment

Clinical Question Rating Recommendation Is risk assessment effective in predicting the develop- Use of risk assessment scales is recommended for predicting CQ6.1 B ment of pressure ulcers? pressure ulcer development. Which risk assessment scale should generallybe CQ6.2 B Use of the Braden Scale is recommended for most situations. used? Assessing the risk factors for pressure ulcer development maybe CQ6.3 What method of assessment used for elderlypatients? C1 considered.

C1 The OH Scale maybe used with bedridden elderlypatients. Which risk assessment scale is recommended for use CQ6.4 with the elderly? The K Scale maybe used with bedridden elderlypatients in C1 hospital. Which risk assessment scale is recommended for The Braden Q Scale maybe considered for risk assessment in CQ6.5 C1 pediatric patients? pediatric patients. Which risk assessment scale is recommended for The SCIPUS scale maybe considered for risk assessment in spinal CQ6.6 C1 spinal cord injurypatients? cord injurypatients. Which risk assessment scale is recommended for A pressure ulcer risk assessment scale specificallydesigned for CQ6.7 C1 subjects in a home-care setting? patients in a home care setting maybe used.

Table 7 Skin assessment

Clinical Question Rating Recommendation The prediction of d1 pressure ulcer prognosis maybe based on the presence of C1 double erythema(graduatedredness)awayfrom a bonyprominence.

How can the depth of pressure ulcers CQ7.1 C1 Ultrasonographymaybe used. be predicted? The ABI(ankle brachial index) maybe used to predict the depth of pressure C1 ulcers in the heel region.

How can redness/d1 stage pressure CQ7.2 C1 The transparent disk method or the finger method maybe considered. ulcer be identified? Palpate the area to see whether pain, induration, edema, or changes in skin C1 Which methods can be used to identify temperature(warm or cool)are present in comparison with the adjacent tissue. CQ7.3 deep tissue injury(DTI)? C1 Consider using ultrasonography.

―G−13― ― 468 ―

Table 8 Skin care

Clinical Question Rating Recommendation What kind of skin care is recommended for patients After cleansing with an appropriate cleansing agent, CQ8.1 suffering from urinaryand/or in C1 skin emollients can be applied to the anal/genital area order to prevent development of pressure ulcers? and to the peripheral skin. The application of polyurethane film dressing, dres- What type of preventive skin care is recommended CQ8.2 B sings with sliding function, and polyurethane foam/soft for use on bonyprominences in elderlypatients? silicone dressing is recommended. Preventive What kind of skin care is recommended for patients A transparent film dressing can be applied to the CQ8.3 C1 care undergoing surgeryin a supine position? sacral area. What kind of skin care is recommended for non- A transparent film dressing or a hydrocolloid dressing CQ8.4 invasive ventilation patients to prevent pressure C1 maybe used for this purpose. ulcer formation at the face mask contact site? What kind of skin care should be given to patients The application of polyurethane foam/soft silicone CQ8.5 under intensive care for the prevention of pressure B dressing is recommended. ulcers? How should the skin surrounding a pressure ulcer Cleansing with a mildlyacidic cleansing agent maybe CQ8.6 be cleansed in order to promote pressure ulcer C1 considered. Care after healing? occurrence In cases with urinaryand/or fecal incontinence, Skin emollients can be applied to the peripheral skin CQ8.7 what kind of skin care is recommended to promote C1 after cleansing with an appropriate cleansing agent. pressure ulcer healing?

Table 9 Repositioning

Clinical Question Rating Recommendation How frequentlyshould the bed bound patient be Basically, repositioning at least every 2 hours is CQ9.1 B repositioned to prevent pressure ulcer? recommended. When a visco-elastic foam mattress is used, reposition- B ing at an interval of 4 hours or less is recommended. How frequentlyshould bed bound patient be CQ9.2 repositioned when a support surface is being used? When a double-layer air-cell mattress overlay is used, Preventive C1 repositioning maybe performed at an interval of 4 care hours or less. When repositioning bed bound patients, what Both the 30-degree and 90-degree lateral recumbent CQ9.3 positions should be undertaken to avoid pressure B positions are recommended. ulcer formation? How can patients in intensive care be repositioned The patient maybe repositioned in an electric rolling CQ9.4 C1 in order to prevent pressure ulcer formation? hospital bed. What positioning is recommended for patients with Positioning maybe performed using bodypressure CQ9.5 C1 articular contracture? dispersion devices/cushions. What positions should be undertaken to promote Anyposition besides the 30-degree tilted side-lying Care after CQ9.6 healing in patients with pressure ulcers in the C1 position or head-of-bed elevated position maybe occurrence gluteal region? undertaken. What kind of repositioning is effective for the Basically,repositioning at least every2 hours maybe CQ9.7 prevention of pressure ulcers in patients with C1 performed. severe pressure ulcers that need intensive care?

―G−14― 褥瘡会誌(2016) ― 469 ―

Table 10 Support surfaces

Clinical Question Rating Recommendation Should support surfaces be used to Use of support surfaces is stronglyrecommended in order to lower CQ10.1 A lower the incidence of pressure ulcers? the incidence of pressure ulcers. Recommend using an alternating-pressure air mattress overlay/ B Which support surface is recom- replacement. CQ10.2 mended for completelyimmobile pa- tients? C1 Consider using a foam mattress replacement.

Which support surface is recom- B Recommend using a double-layer air-cell mattress. CQ10.3 mended for prevention of pressure An alternating-pressure air mattress overlay/ replacement, air- ulcers in elderlyindividuals? C1 filled mattress overlay, or foam mattress may also be used.

Which support surfaces are recom- B Recommend using a low air pressure mattress. CQ10.4 mended for prevention of pressure A low-air-loss bed, an alternating-pressure air mattress overlay, or ulcers in intensive care patients? C1 an air-filled mattress replacement mayalso be considered. Support surfaces on the operating table are recommended for A patients at risk of developing pressure ulcers. In addition to using support surfaces, visco-elastic pads or gel B applied to the heel area, cubital region, and other areas with bony Preventive Which tools, including support sur- prominences is recommended during operations. care faces, are effective in preventing the CQ10.5 During and after operations, an alternating-pressure air mattress development of pressure ulcers during C1 overlays/replacement may be used. perioperative periods? The bead bed systemmaybe used during surgeryfor patients C1 undergoing surgeryto repair femoral-neck fracture.

Thermoactive viscoelastic foam overlaymaybe used for patients C1 who will undergo cardiac surgery. Which support surfaces can be used to CQ10.6 facilitate care for convalescent patients C1 An automatic turning air mattress maybe used. in a home-care setting? Using an alternating-pressure air mattress replacement is recom- B mended. The use of a double-layer air-cell mattress with a detachable upper Which support surfaces provide the B layer is recommended for patients after surgery of the heart/great CQ10.7 greatest comfort both while awake and vessels. sleeping? For terminallyill patients, an alternating-pressure air mattress with C1 automatic adjustment to the patient's weight and position maybe considered. What precautions should be taken CQ10.8 C1 Monitor the deterioration of the foam due to fatigue. when using foam mattresses? Use of an air-fluidized bed or low-air-loss bed is strongly A recommended to promote healing in D3-D5 pressure ulcers or pressure ulcers in multiple sites. Use of an alternating-pressure air mattress with automatic adjustment for the patientls position and weight, an alternating- Which support surfaces are recom- C1 pressure large-cell ripple mattress, a double-layer air-cell mattress, Care after CQ10.9 mended for promoting healing in d1, d2, or a low air pressure mattress maybe considered to promote occurrence and D3-D5 pressure ulcers? healing in d2 or deeper pressure ulcers. Use of an air-filled mattress overlaymaybe considered to promote C1 healing in d1/2 pressure ulcers. Use of an alternating-pressure air mattress with automatic C1 adjustment to the patientls weight and position maybe considered after flap reconstruction for pressure ulcers.

―G−15― ― 470 ―

Table 11 Patient education

Clinical Question Rating Recommendation Education/training in repositioning and using support surfaces can C1 be carried out . Education/training in anyor all of the following maybe given : the etiologyof ulcers, risk factors, staging, principles of wound healing, C1 nutritional support, program of skincare and skin inspection, and How can patients and their familyor management of incontinence. Preventive caregivers be educated to prevent the CQ11.1 Periodic telephone consultations with a health care professional care development or recurrence of pressure C1 ulcers? maybe done. Periodic skin assessment bya medical expert using remote- B controlled imaging is recommended. Education byan e-learning systemled bythe health care C1 professional maybe given. Information concerning the procedure to contact appropriate How should patients/family/caregivers C1 Care after medical center maybe provided in the event of abnormalities. CQ11.2 be educated/trained in the care of occurrence existing pressure ulcers? C1 Education bymedical experts maybe performed using e-learning.

Table 12 Outcome management

Clinical Question Rating Recommendation Choice of support surface based on the Braden Scale is stronglyrecom- A mended.

Implementation of comprehensive programs and protocols maybe consi- B dered.

C1 Choice of support surface based on the OH Scale maybe considered.

Which measures should be undertaken in CQ12.1 a hospital care setting to prevent pressure C1 Deploymentof a multidisciplinarywound care team maybe considered. ulcers? C1 Assignment of wound ostomyand continence nurse maybe considered.

Introduction of reimbursement system for pressure ulcer high risk patient C1 care maybe considered.

Electronic charts including a pressure ulcer risk assessment tool maybe C1 considered. Implementation of comprehensive programs and protocols maybe consi- C1 Which measures are recommended for dered. CQ12.2 pressure ulcer prevention in long-term Use of an algorithm incorporating the Braden Scale to implement preventive care facilities? C1 care maybe considered.

C1 Deploymentof a multidisciplinarywound care team maybe considered.

Which measures are recommended to Introduction of reimbursement system for pressure ulcer high risk patient CQ12.3 promote healing of pressure ulcers in a C1 care maybe considered. hospital care setting? C1 Assignment of wound ostomyand continence nurse maybe recommended.

Which measures are recommended to B Deployment of a multidisciplinary wound care team is recommended. CQ12.4 promote healing of pressure ulcers in a Implementation of comprehensive programs and protocols maybe consi- long-term care facility? C1 dered.

―G−16― 褥瘡会誌(2016) ― 471 ―

Table 13 QOL/ Pain

Clinical Question Rating Recommendation How can the qualityof life(QOL)of press- The QOL of the patients may be assessed along physiological, psychological, CQ13.1 C1 ure ulcer patients be assessed? and social parameters. For which stage of pressure ulcer is pain CQ13.2 C1 Pain maybe assessed at anystage of pressure ulcer. assessment recommended? Pain assessment maybe conducted during treatment and time with no CQ13.3 When should pain assessment be conducted? C1 treatment including rest. Which tools can be used to assess pressure- Pressure-ulcer-related pain maybe assessed using a subjective pain CQ 13.4 C1 ulcer-related pain? assessment scale.

―G−17― ― 472 ―

Fig. 2 Algorithm illustrating conservative treatments

closelymonitoring for changes in the condition of the Guidelines wound itself. As external medications, oleaginous CQ 1 External medications preparations that are known to be highlyefficacious in CQ 1. 1:Which external medications are recom- protecting wound surfaces, such as white petrolatum, mended to treat acute pressure ulcers? are preferred for treatment1). If the ulcer surface is [ Recommendation ]External medications with infected, silver sulfadiazine and similar preparations oleaginous bases with a high degree of efficacyin with nonspecific anti-bacterial properties are recom- protecting wound surfaces such as those of zinc oxide, mended, as antibiotic topical agents typically fail to dimethyl isopropylazulene, and white petrolatum and produce the desired effect. those with an emulsion base with a high moisture Thus, for the treatment of acute pressure ulcers, content(O/W)such as silver sulfadiazine mayalso external medications with oleaginous bases with a be considered. high degree of efficacyin protecting the wound [Rating]C1 surface such as zinc oxide and dimethyl isopropyla- [Analysis]At present, observations of only a most zulene and those with an emulsion base with a high general nature exist regarding the choice of external moisture content(O/W)such as silver sulfadiazine medications for the treatment of acute pressure mayalso be used. ulcers1). As a first step, it is critical to ascertain the References cause of the injurybefore considering the typeof topical therapyto employ.This is underscored bythe 1)Kawakami S, Shimada K : Treatment of acute press- fact that in manycases of acute pressure ulcers, the sure ulcers. Modern Physician, 28:506-507, 2008. presence of deep tissue damage mayat first go (LevelⅥ)(Japanese) unnoticed, and lead naturallyto an exacerbation of the condition. For this reason, the basic considerations CQ 1.2:Which external medications are indicated when employing topical therapy to treat acute when deep tissue injury(DTI)is suspected? pressure ulcers include maintaining an optimally [ Recommendation ]Dailyobservation of the moist environment conducive to wound healing while wound must not be neglected, and external medica-

―G−18― 褥瘡会誌(2016) ― 473 ― tions with oleaginous bases with a high degree of sometimes used for the treatment of non-blanchable efficacyin protecting the wound surface such as zinc redness and purpura because of its anti-inflammatory oxide and dimethyl isopropylazulene may also be properties and reducing effects on edema1), its efficacy used. is generallylow. [Rating]C1 Thus for the treatment of redness/purpura, protec- [Analysis]At present, only expert opinion exists tion of the wound surface is important, and external regarding the choice of topical agents for the medications with oleaginous bases with a high degree treatment of deep tissue injuries(DTI). The term of efficacyin protecting the wound surface such as DTI was proposed bythe NPUAP(2007)to define a zinc oxide and dimethyl isopropylazulene may also be condition in which the appearance of overlying skin used. conceals the actual extent of damage to underlying References tissue, which becomes more apparent with time as the wound evolves into deeper layers of tissue1). 1)Nakamura I, Ozaki M, Watanabe B : Anti- If deep tissue injuryis suspected, pressure should inflammatoryeffects of azulen. Rinsho Hifuka, 12: be relieved immediatelyand the condition of the 769-778, 1958.(LevelⅥ)(Japanese) wound closelymonitored. The wound maybe occluded if necessary, but in a manner which will CQ 1. 4:Which external medications are recom- allow the condition of the wound to be readily mended for cases involving blistering? monitored. [ Recommendation ]External medications with Thus, if DTI is suspected, dailyobservation of the oleaginous bases with a high degree of efficacyin wound must not be neglected, and external medica- protecting the wound surface such as zinc oxide and tions with oleaginous bases with a high degree of dimethyl isopropylazulene may also be used. efficacyin protecting the wound surface such as zinc [Rating]C1 oxide and dimethyl isopropylazulene may also be [Analysis]The choice of external medications for used. the treatment of blisters is based onlyon expert opinion. Treatments prioritize wound surface protec- References tion and tend to focus on the type of dressing used for 1)Kadono T : Deep tissue injury. Rinsho Hifuka, 63 this purpose. However, blisters maybe punctured if (5):38-41, 2009.(LevelⅥ)(Japanese) tense, and ruptured blisters mayrequire treatments usuallyemployedfor erosions and ulcers. In cases CQ 1. 3:Which external medications are recom- where external medications are employed, white mended for cases involving redness/purpura? petrolatum or similar petrolatum-based topical agents [Recommendation]It is important to protect the are preferred for their abilityto stimulate wound wound surface, and external medications with oleagi- healing while protecting the wound surface. Although nous bases with a high degree of efficacyin protecting zinc oxide in a petrolatum-based preparation is the wound surface such as zinc oxide and dimethyl customarilyemployedfor this purpose not only isopropylazulene may also be used. because of its locallyastringent effects and mildly [Rating]C1 properties, but also for its abilityto protect [ Analysis ]Only expert opinions are available to the wound surface and reduce inflammation while treat non-blanchable redness and purpura. Treat- promoting tissue regeneration1), its efficacyis general- ments prioritize the protection of wound surfaces and lyweak. tend to focus on the types of dressing used for this Thus, for the treatment of blisters, external purpose. In cases which call for treatment using medications with oleaginous bases with a high degree external medications, white petrolatum or similar, of efficacyin protecting the wound surface such as petrolatum-based topical agents are preferred for zinc oxide and dimethyl isopropylazulene may also be their abilityto stimulate wound healing while used to protect the wound surface. protecting the wound surfaces. Although dimethyl isopropylazulene in a petrolatum-based preparation is

―G−19― ― 474 ―

Thus, for the treatment of erosion/shallow ulcer, References zinc oxide, dimethyl isopropylazulene, or, expecting 1)Edited bythe Japanese Pharmacopoeia Instruction promotion of re-epithelialization, alprostadil alfadex, Manual Editorial Committee. The Japanese Pharma- bucladesine sodium, or lysozyme hydrochloride may copoeia, Fourteenth Edition : Text with Annotations, be used. 1257-1259, Hirokawa Publishing Company, Tokyo, References 2001.(LevelⅥ)(Japanese) 1)Nakamura I, Ozaki M, Watanabe B, et al : Anti- CQ 1. 5:Which external medications are recom- inflammatoryeffects of azulene. Rinsho Hifuka, 12: mended to treat erosions and shallow ulcers? 769-778, 1958.(LevelⅥ)(Japanese) [ Recommendation ]Zinc oxide or dimethyl isop- 2)Imamura S, Sagami S, Ishibashi Y, et al : Clinical study ropylazulene may be used. Alprostadil alfadex, of prostaglandin E1 ointment( G-511 ointment )in bucladesine sodium, or lysozyme hydrochloride may chronic skin ulcers. Well-controlled comparative also be used to promote re-epithelialization. study with lysozyme chloride ointment. J Clin Ther [Rating]C1 Med, 10:127-147, 1994.(LevelⅡ)(Japanese) [Analysis]The choice of external medications for the treatment of erosion and shallow ulcers is based CQ 1.6:Are external medications recommended if onlyon expert opinion. As the treatment of erosion pain accompanies the pressure ulcer? and shallow ulcers should prioritize protecting the [Recommendation]While external medications do wound surface and maintaining an optimallymoist not relieve pain of the wound, theycan mitigate pain environment, the choice of dressing becomes crucial. bymaintaining the wound surface in an appropriate In using external medications, white petrolatum, moist environment. External medications of drugs which promotes wound healing bythe wound surface- such as dimethyl isopropylazulene with an oleaginous protecting effect, or petrolatum-based preparations is base with a high wound-surface-protecting effect or used. Although zinc oxide, available as a petrolatum- those of drugs such as silver sulfadiazone and based ointment, is not highlyefficacious, it possesses tretinoin tocoferil in an emulsion base with a high mild, locallyastringent, protective, and antiseptic, moisture content(O/W)mayalso be used. properties while simultaneouslyreducing inflamma- [Rating]C1 tion and promoting tissue regeneration. Dimethyl [Analysis]Pain control of pressure ulcer is impor- isopropylazulene, also available in a petrolatum base, tant in the acute period. Since manypatients cannot is well-known for its anti-inflammatoryproperties and complain of pain, it is important for the medical staff to its reducing effect on edema1), but its efficacyis always remember pain and appropriately use analge- generallylow. sics. Regarding external medications, external applica- Alprostadil alfadex, available in a preparation using tion of Xylocaine jelly has been attempted, but its Plastibase®, is effective in stimulating wound healing usefulness has yet to be established. Generally, pain bypromoting re-epithelialization, skin blood flow, and can be mitigated bymaintaining the wound surface in angiogenesis2). While being a potent pro-circulatory an appropriate moist environment. For this purpose, agent, it is sometimes irritant to the skin. Bucladesine oleaginous bases(e.g., white petrolatum)and emul- sodium possesses superior absorbancydue to its sion bases with high wound-surface-protecting effects macrogol base and is recommended for cases with are considered useful. Randomized controlled trials excessive exudate. Other effects of bucladesine using topical applications of morphine to relieve pain sodium are: reduction of ulcer size, wound contraction, associated with pressure ulcers have been conducted local pro-circulatoryeffects, angiogenesis, granulation outside Japan1, 2), but the use of morphine is not tissue promotion, and re-epithelialization. Lysozyme common in this country. As observed above, while hydrochloride, which is an emulsion base, is used in external medications do not relieve pain of the wound, expectation of wound size reduction. While promoting theycan mitigate pain bymaintaining the wound keratinocyte and fibroblast growth, lysozyme hyd- surface in an appropriate moist environment. Exter- rochloride is minimallyirritant to the skin. nal medications of drugs such as dimethyl isopropyla-

―G−20― 褥瘡会誌(2016) ― 475 ― zulene with an oleaginous base with a high wound- for lysozyme hydrochloride, being significantly higher surface-protecting effect or those of drugs such as with povidone-iodine sugar(p<0.01)4). In the latter silver sulfadiazone and tretinoin tocoferil in an study, the efficacy rate was 25% for povidone-iodine emulsion base with a high moisture content(O/W) sugar and 0% for ointment containing extract from mayalso be used. hemolyzed blood of young calves(p<0.01)5). Further, a retrospective analysis of a case in which References the DESIGN score decreased following the application 1)Flock P : Pilot studyto determine the effectiveness of of povidone-iodine sugar failed to establish any diamorphine gel to control pressure ulcer pain. J Pain relationship between the amount of exudate and the Symptom Manage, 25:547-554, 2003.(LevelⅡ) decrease in the DESIGN score6). 2)Zeppetella G, Paul J, Ribeiro MD : Analgesic efficacy The ameliorative effect of dextranomer and iodine of morphine applied topicallyto painful ulcers. J Pain ointment on exudation has been documented in past Symptom Manage, 25:555-558, 2003.(LevelⅡ) case reports. Of the five cases reported, four demonstrated a decrease in the initiallymedium to CQ 1. 7:Which external medications are recom- high levels of exudation following treatment with mended for pressure ulcers with excessive exudate? dextranomer7). Furthermore, case reports have [Recommendation] documented a significant improvement in the ઃ.Cadexomer-iodine and povidone-iodine sugar DESIGN-R score and the E score in DESIGN following are both highlyabsorbant and are recommended for iodine ointment treatment8, 9). pressure ulcers with excessive exudate. Thus, as external medications for excessive exuda- [Rating]B tion wounds, and povidone-iodine ઄.Dextranomer and iodine ointment maybe sugar are assigned a rating of B, while dextranomer considered. and iodine ointment are assigned a rating of C1. [Rating]C1 References [ Analysis ]Cadexomer-iodine, fibrinolysin- deoxyribonuclease-containing ointment, dextranomer 1)Kukita A, Ohura T, Aoki T, et al : Clinical evaluation and dextrin-polymer-base were tested to determine of NI-009 on various cutaneous ulcers. Comparative their relative efficacyin alleviating excessive exuda- studywith Elase-C Ointment. J Clin Ther Med, 6 tion in pressure ulcers. The results of the test (4):817-848, 1990.(LevelⅡ)(Japanese) indicated an improvement rate of 65. 8% for 2)Ishibashi Y, Ohkawara A, Kukita A, et al : Clinical cadexomer-iodine in comparison with fibrinolysin- evaluation of NI-009 on various cutaneous ulcers. deoxyribonuclease-containing ointment(46.2%), de- Comparative studywith Debrisan. J Clin Ther Med, 6 monstrating a statisticallygreater effect for the (4):785-816, 1990.(LevelⅡ)(Japanese) former(p<0.05)1). 3)Anzai T, Shiratori A, Ohtomo E, et al : Evaluation of The studyalso indicated an improvement rate of 65. clinical utilityof NI-009 on various cutaneous ulcers. 2% for cadexomer-iodine in comparison with dextra- Comparative studywith base. J Clin Ther Med, 5 nomer(18.2%), likewise demonstrating the statisti- (12):2585-2612, 1989.(LevelⅡ)(Japanese) callysignificantlygreater efficacyof the former( p< 4)Imamura S, Uchino H, Imura Y, et al : The clinical 0.01)2). On the other hand, cadexomer-iodine showed effect of KT-136( sugar and povidone-iodine oint- an efficacyrate of 33. 3% in comparison with the ment)on decubitus and skin ulcers : A comparative dextrin-polymer-base(24%)with no significant dif- study with lysozyme ointment. Jpn Pharmacol Ther, ference in efficacyobserved 3). 17(Suppl.1):255-279, 1989.(LevelⅡ)(Japanese) The ameliorative effect of povidone-iodine sugar on 5)KT-136 Skin Ulcers Comparative StudyGroup : exudation has been compared with that of lysozyme Comparative clinical studyof sugar and povidone- hydrochloride ointment in one study and with that of iodine ointment( KT-136 )and solcoseryl ointment ointment containing extract from hemolyzed blood of (SS-094 : Ointment). Jpn Pharmacol Ther, 17(4): young calves in one. In the former study, the efficacy 1789-1813, 1994.(LevelⅡ)(Japanese) rate was 49.1% for povidone-iodine sugar and 27.8% 6)Kobayashi A, Muto S, Chino K, et al : Analysis of the

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therapeutic effectiveness of a topical agent in the (Japanese, English abstract) treatment of pressure ulcers using DESIGN. Jpn J PU, 3)Yoshida K : Tips for pressure ulcer pharmacother- 10(2):111-116, 2008.(LevelⅤ)(Japanese, English apeutics with case reports. Jpn J PU, 12(2):85-92, abstract) 2010.(LevelⅥ)(Japanese, English abstract) 7)Horio T, Kawai S, Moriguchi T, et al:Therapeutic effects of SK-P-9701(dextranomer paste)on press- CQ 1.9:How should a pressure ulcer be cleaned? ure ulcers. Jpn J JPU, 3(3):355-364, 2001.(Level [ Recommendation ]Cleanse the pressure ulcer Ⅴ)(Japanese, English abstract) using isotonic saline or tap water in sufficient 8)Nagai Y, Amano H, Okada E, et al:Therapeutic quantities to reduce the microbial count on the wound effectiveness of Iodoco® ointment 0.9% in the treat- surface. ment of pressure ulcers. J New Rem & Clin, 59(7): [Rating]C1 1215-1223, 2010.(LevelⅤ)(Japanese) [Analysis]According the latest systematic review 9)Tachibana T, Fujii N, Wakabayashi M, et al : of papers comparing wound cleaning solutions and Therapeutic effect of 0.9% iodine-containing ointment cleaning techniques published in 20131), pressure on yellow stage of pressure ulcers. Jpn JPU, 12(4): ulcers cleaned with isotonic saline( VulnopurTM ) 513-519, 2010.( LevelⅤ )( Japanese, English ab- containing aloe vera, silver chloride, or decyl glucoside stract) (59 cases)showed a demonstrable improvement in their PSST(Pressure Sore Status Tool)scores(P= CQ 1. 8:Which external medications are recom- 0.025)compared to those cleaned onlywith isotonic mended in pressure ulcers with minimal exudate? saline(74 cases). [Recommendation]External medications of silver No significant difference was noted in the PSST sulfadiazine and tretinoin tocoferil in an emulsion base score of pressure ulcers cleaned with either isotonic (O/W)with a high moisture content maybe used for saline only(four cases)or with tap water only(four infected and uninfected wounds, respectively. cases). With regard to the cleansing techniques, no [Rating]C1 significant difference was noted in treatment effect [ Analysis ]There are no evidence-based reports between the so-calledk whirlpool lmethod( 24 besides expert opinion recommending external cases )and more conventional lavation( 18 cases ). medications for the treatment of minimallyexudative When pulse lavation was compared with sham wounds1−3). As external medications, emulsion-base lavation, the area of ulcer at the end of the 3-week ointments are recommended for such wounds, both studyperiod was significantlyreduced in the pulse byreason of their high moisture content and lavation group compared with sham lavation( P< penetrating ability. Emulsion-base ointments also 0.05). Also, of the 36 cases featured in one compara- have the added benefit of promoting water retention tive case report2) 6 out of 19 cases cleaned with 50ml in drywound surfaces. A representative example of isotonic saline and 5 out of 29 cases cleaned with such an emulsion-base external is silver 100ml isotonic saline demonstrated an increase in sulfadiazine, which possesses antibacterial properties microbial count, whereas no increase in microbial and softens necrotic tissue, and tretinoin tocoferil, count was observed in anyof the 12 cases cleaned which promotes granulation tissue formation1−3). with 200ml isotonic saline. Thus, as external medications for minimal exuda- In summary, while wound cleansing is effective in tive wounds, silver sulfadiazine and tretinoin tocoferil speeding recovery, there is no evidence to endorse a were rated as C1. particular cleansing solution or method. Pressure ulcers maybe cleaned adequatelybyusing sufficient References quantities of isotonic saline or tap water. 1)Nagai Y : Topical drug and wound dressing. Jpn J PU, References 10(1):1-9, 2008.(LevelⅥ)(Japanese, English ab- stract) 1)Moore Z, Cowman S : Wound cleansing for pressure 2)Furuta K : Selection and technical aspects of topical ulcers. Cochrane Database Syst Rev,(3):CD004983, drugs. Jpn J PU, 11( 2 ):92-100, 2009.( LevelⅥ ) 2013.(Level Ⅰ)

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2)Ohura T, Iwasawa A, Kiryu M, et al : Effect of clean- Treatment of Pressure Ulcers Clinical Practice sing byphysiologicalsaline on bacterial counts of Guidelines No. 15, AHCPR Publication 95-0652. US pressure ulcer. Jpn J PU, 9( 2 ):183-191, 2007. Department of Health and Human Services, Public (LevelⅣ)(Japanese, English abstract) Health Service, Agencyfor Health Care Policyand Research, Rockville, MD, 1994. CQ 1. 10:How should pressure ulcers be disin- 3)European Pressure Ulcer AdvisoryPanel : Pressure fected? ulcer treatment guidelines. EPUAP business office, [ Recommendation ]Wound cleansing is usually Oxford, 1999. adequate to prevent infection. However, if the wound is clearlyinfected or if there is excessive exudate or CQ 1.11:Which external medications are recom- pus, the wound maybe disinfected using antiseptics mended for pressure ulcers accompanied byinfection prior to cleansing. and inflammation? [Rating]C1 [Recommendation] [Analysis]A systematic review of various studies 1.Cadexomer-iodine, silver sulfadiazine, and selected bytheir qualityand dealing with the povidone-iodine sugar are recommended for their retardative effect of povidone-iodine on wound abilityto control infections. healing1), has shown that the majorityof cases arguing [Rating]B against the use of povidone-iodine were either in vitro 2.Fradiomycin sulfate-crystalline trypsin, or animal model studies whereas 71% of the highly povidone-iodine, iodine ointment, and iodoform gauze ranked human studies supported its use. Further, maybe considered. 57% of the studies with the highest impact factor [Rating]C1 supported its use as an antiseptic. There are only [Analysis]A randomized controlled trial with 60 scantydata regarding the relationship between subjects comparing cadexomer-iodine with dextra- symptoms of infection and retardation of healing due nomer demonstrated significant decreases in levels of to use of antiseptics and it is not at all clear that pus(p<0.05)1), one of the assessment categories in povidone-iodine has a toxic or retardative effect on the study, following treatment with cadexomer-iodine. wound healing. Another randomized controlled trial comparing The 1994 AHCPR guidelines2) claim that lavation silver sulfadiazine with a placebo group( total 77 with isotonic saline is sufficient for cleansing infected subjects)reported a significant anti-microbial effect pressure ulcers and that cleansing solutions and (p<0.01)in 64.7% and 27% of the subjects, respec- antiseptics are unnecessary. On the other hand, the tively2). In an open randomized controlled trial EPUAP guidelines of 19993) state that use of antisep- comparing povidone-iodine sugar with lysozome tics is indicated in cases in which there are clear signs hydrochloride involving 141 subjects, 32.8% and 14.8% of infection and abnormallylarge amounts of exudates of the subjects, respectively, reported a significant or pus. improvement in microbial infection rate(p<0.05)3). In summary, even at the wound stage at which On the other hand, while there are case reports debridement and infection control are normallycalled concerning fradiomycin sulfate-crystalline trypsin for, cleansing with isotonic saline or tap water is povidone-iodine, iodine ointment, and iodoform, there sufficient in most cases. However, in cases in which is as yet little evidence on their anti-microbial effect. there are clear symptoms of infection, the wound may In summary, in cases in which there are clear be disinfected byusing povidone-iodine. symptoms of infection, cadexomer-iodine, silver sulfa- diazine, and povidone-iodine sugar are recommended References as a means of controlling the infection. Fradiomycin 1)Banwell H : What is the evidence for tissue regenera- sulfate-crystalline trypsin, povidone-iodine, iodine tion impairment when using a formulation of PVP-I ointment, and iodoform maybe used for treatment on antiseptic on open wounds?. Dermatology, 212 a dailybasis. (Suppl1):66-76, 2006.(LevelⅠ) 2)Bergstrom N, Allman RM, Alvarez OM, et al :

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& Clin, 59:1215-1223, 2010.(LevelⅤ)(Japanese) References 2)Tachibana T, Fujii N, Wakabayashi M, et al : 1)Ishibashi Y, Ohkawara A, Kukita A, et al : Clinical Therapeutic effect of 0.9% iodine-containing ointment evaluation of NI-009 on various cutaneous ulcers. on yellow-stage of pressure ulcers. Jpn J PU, 12(4): Comparative studyof Debrisan. J Clin Ther Med,6 513-519, 2010.( LevelⅤ )( Japanese, English ab- (4):785-816, 1990.(LevelⅡ)(Japanese) stract) 2)Yura J, Ando M, Ishikawa S, et al : Clinical evaluation 3)Takagi S, Makino T, Kosaka M, et al : Comparison of of silver sulfadiazine( T107 )in the treatment of the antibacterial effects of two iodine-containing decubitus ulcer or chronic dermal ulcers : Double- antiseptics.Jpn J PU, 11(4):528-532, 2009.(Level blind studyincluding placebo. Chemotherapy,32: Ⅲ)(Japanese, English abstract) 208-222, 1984.(LevelⅡ)(Japanese) 4)Imamura S : Efficacyand safetyin chronic administra- 3)Imamura S, Uchino H, Imura Y, et al:The clinical tion of white sugar and povidone-iodine phar- effect of KT-136( sugar and povidone-iodine oint- maceuticals( U-pasta Kowa )for decubitus. Acta ment )on decubitus ulcers : A comparative study Dermatologica, 89:727-735, 1994.( LevelⅤ ) with lysozyme ointment. Jpn Pharmacol Ther, 17 (Japanese) (Suppl.1):255-280, 1989.(LevelⅡ)(Japanese) 5)Tachibana T : Critical colonization. Jan J Clin Der- matol, 63:42-46, 2009.(LevelⅥ)(Japanese) CQ 1.12:Which external medications are recom- 6)Tachi M : Management of chronic wound infection. mended when delayed wound healing due to critical Jpn J PU, 11(2):101-104, 2009.(LevelⅥ)(Japanese, colonization is suspected in the period of granulation English abstract) tissue formation? [ Recommendation ]Topical medications with an CQ 1.13:Which external medications are recom- anti-microbial properties, such as cadexomer-iodine mended to accelerate granulation formation in press- ointment, povidone-iodine sugar, iodine ointment, or ure ulcers with deficient granulation formation? silver sulfadiazine maybe used. [Recommendation] [Rating]C1 1.Alcloxa, trafermin, tretinoin tocoferil and [ Analysis ]Although critical colonization is a povidone-iodine sugar, all of which are known to serious pathological condition which has the potential accelerate granulation formation, are recommended. to delaywound recoveryin pressure ulcers, there are [Rating]B as yet no controlled studies dealing specifically with 2.Alprostadil alfadex, bucladesine sodium, or this condition. Further, although two case studies lysozyme hydrochloride may be considered. exist which mention the anti-microbial effect of iodine [Rating]C1 ointment1, 2) and one evidence levelⅢ report which [ Analysis ]Alcloxa : One study of the effect of compares the effect of cadexomer-iodine ointment and aluminum chlorohydroxy allantoinate on the accelera- povidone-iodine sugar, onlyone studydeals specifical- tion of granulation formation involved a randomized lywith pressure ulcers 3). controlled trial using solcoseryl( extract from The use of the above-mentioned external medica- hemolyzed blood of young calves)1). The results for tions is recommended on the basis of the case studies each of the 27 subjects enrolled showed a significantly mentioned as well as expert opinion4−6). greater increase in granulation formation when Thus, when delayed wound healing due to critical compared with the control group. colonization is suspected in the period of granulation Trafermin : Although a randomized controlled trial tissue formation, cadexomer-iodine ointment, comparing the efficacyof trafermin with that of povidone-iodine sugar, iodine ointment, or silver povidone-iodine sugar, GM-CSF and low concentration sulfadiazine maybe used. of fibroblast growth factor in reducing wound size does exist2−5), the data on granulation formation are References not shown. However, one historical controlled trial6) 1)Nagai Y, Amano H, Okada E, et al : Clinical effects of has reported a significantlygreater granulation iodine ointment 0.9% on pressure ulcers. J New Rem formation effect for trafermin in comparison with the

―G−24― 褥瘡会誌(2016) ― 479 ― control. The studyfurther reported that trafermin on pressure ulcers : A comparative studyof solcoseryl was especiallyefficacious when administered in the ointment. Jp J Clin Exp Med, 59( 6 ):2097-2112, earlystages of treatment and enhanced the treatment 1982.(LevelⅡ)(Japanese) effect. Although the evidence level for trafermin is Ⅳ, 2)Ishibashi Y, Soeda S, Ohura T : Clinical effects of KCB- this medication merits recommendation on the basis 1, a solution of recombinant human basic fibroblast of case series reports documenting its efficacyas well growth factor, on skin ulcers: A phaseⅢ studywith as the expert opinions given in its favor7, 8). comparisons to sugar and povidone iodine ointment. J Tretinoin tocoferil : In the two existing open Clin Ther Med,12(10):2159-2187, 1996.(LevelⅡ) randomized controlled trials comparing the granula- (Japanese) tion formation effect of tretinoin tocoferil with that of 3)Martin CR : Sequential cytokine therapy for pressure lysozyme hydrochloride and bendazac ointment9, 10), ulcers, clinical and mechanistic response. Ann Surg, tretinoin tocoferil was observed to have a significantly 231:600-611, 2000.(LevelⅡ) greater effect than either of the controls. 4)Ishibashi Y, Soeda S, Ohura T : The clinical effects of Povidone-iodine sugar : An open randomized trial KCB-1 on skin ulcers : A double blind trial to comparing povidone-iodine sugar with lysozyme determine optimal dosage. J Clin Ther Med, 12(9): hydrochloride reported a superior granulation forma- 1809-1834, 1996.(LevelⅡ)(Japanese) tion effect for lysozyme hydrochloride than for 5)Robson MC, Phillips LG, Lawrence WT, et al : The povidone-iodine sugar11). safetyand effect of topicallyapplied recombinant Alprostadil alfadex : Although there is a rando- basic fibroblast growth factor on the healing of mized trial comparing the wound reduction effect of chronic pressure sores. Ann Surg, 216(4):401-408, alprostadil alfadex with that of lysozyme 1992.(LevelⅡ) hydrochloride12) with the exception of expert opinion, 6)Ohura T, Nakajo T, Moriguchi T : Clinical efficacyof there are no studies attesting to the granulation bFGF on pressure ulcers : A case controlled study formation effect of alprostadil alfadex. employing a new method for evaluation. Jp J PU, 6 Bucladesine sodium : At present two random (1):23-34, 2004.(LevelⅣ)(Japanese, English ab- controlled trials exist comparing the effect of buc- stract) ladesine sodium, lysozome hydrochloride, and macro- 7)Furuta K, Miura H, Endo T : Clinical effects of gol ointment on accelerating granulation formation. In fibroblast sprayon pressure ulcers. Jp J Clin Exp both reports, bucladesine sodium reportedlyshowed Med, 80(7):187-194, 2003.(LevelⅤ)(Japanese) an accelerative effect equal to that of lysozome 8)Ishibashi Y, Harada S, Takemura T : Clinical effects of hydrochloride, but significantly greater than that of KCB-1( bFGF )on skin ulcers, Clinical trial for 12 macrogol ointment13, 14). However, at present there are weeks. J Clin Ther Med, 12:2117-2129, 1996.(Level no studies documenting its effect on granulation Ⅴ)(Japanese) formation. 9)L-300 clinical trial studygroup : Controlled compara- Lysozome hydrochloride : Two open randomized tive study of the effect of L-300 and lysozyme trials have been conducted comparing lysozome hydrochloride on skin ulcers. J Clin Ther Med, 7: hydrochloride with bendazac ointment( evidence 654-665, 1991.(LevelⅡ)(Japanese) levelⅡ)15). In this report, no significant difference was 10)L-300 clinical trial studygroup : Clinical evaluation of observed in granulation. Thus, when granulation is L-300 ointment for treatment of skin ulcers : A insufficient and must be promoted, the use of alcloxa, controlled comparative studyusing bendazac oint- trafermin, tretinoin tocoferil, or povidone-iodine sugar ment as a control. J Clin Therap Med, 7(2):437- is recommended. Alprostadil alphadex, bucladesine 456, 1991.(LevelⅡ)(Japanese) sodium, and lysozyme hydrochloride may also be 11)Imamura S, Uchino H, Imura H, et al : The clinical used. effect of KT-136( sugar and povidone-iodine oint- ment )on decubitus ulcers : A comparative study References using lysozyme ointment. Jpn Pharmacol Ther, 17 1)Mizutani H, Ootsuki T, Matsumoto H, et al : Clinical (Suppl.1):255-280, 1989.(LevelⅡ)(Japanese) effects of topical aluminum chlorhydroxy allantoinate 12)Imamura S, Sagami S, Ishibashi Y : Clinical studyof

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prostaglandin E1 ointment( G-511 Ointment )in showed that treatment with the former resulted in a chronic skin ulcers. Well-controlled comparative significantlygreater( p<0. 05 )reduction in wound study with lysozyme chloride ointment. J Clin Ther size4). A randomized controlled trial comparing Med, 10:127-147, 1994.(LevelⅡ)(Japanese) povidone-iodine sugar and trafermin( n=63 ) 13)Niimura M, Ishibashi Y, Imamura S, et al : Clinical showed that both agents produced an equal reduction study of the effect of dibutyryl cyclic AMP ointment in wound size5). Similarly, a randomized controlled ( DT-5621 )on chronic skin ulcers. Well-controlled trial( n=68 )comparing lysozyme hydrochloride comparative study with lysozyme ointment. J Clin with bucladesine sodium resulted in equal wound size Ther Med, 7(3):677-692, 1991.(LevelⅡ)(Japanese) reduction ratio6). However, it is unclear whether or not 14)Niimura M, Yamamoto K, Kishimoto S, et al : Clinical the percentage of wound size reduction was mea- study of the effect of dibutyryl cyclic AMP ointment sured following adequate granulation formation. In ( DT-5621 )on chronic skin ulcers. Jpn Pharmacol view of the wound treatment process, in actual clinical Ther, 18:2757-2770, 1990.(LevelⅡ)(Japanese) practice it is advisable to assess epithelialization after 15)KH101 studygroup : Clinical studyof the effect of sufficient granulation formation has been confirmed. KH101( Reflap ointment )on chronic skin ulcers. In view of the information given above and the Nishinihon J Dermatol, 48(3):553-562, 1986.(Level actual conditions of clinical practice, alcloxa, alprosta- Ⅱ)(Japanese, English abstract) dil alfadex, trafermin, bucladesine sodium, and povidone-iodine sugar are recommended for reducing CQ 1.14:Which external medications are recom- wound size. Zinc oxide, dimethylisopropylazulen, mended for wound reduction in pressure ulcers with extract from hemolyzed blood of young calves, or sufficient granulation formation? lysozyme hydrochloride may also be used. [Recommendation] References 1.Alcloxa, alprostadil alfadex, trafermin, bucladesine sodium, and povidone-iodine sugar are recommended. 1)Mizutani H, Ootsuki T, Matsumoto H, et al : Clinical [Rating]B evaluation of Aluminum chlorohydroxy allantoinate 2.Zinc oxides, dimethyl isopropylazulene, extract powder(ISP)in patients with pressure ulcers : A from hemolyzed blood of young calves, and lysozyme comparison with Solcoseryl ointment. Jp J Clin Exp hydrochloride may be used. Med, 59:2097-2112, 1982.(LevelⅡ)(Japanese) [Rating]C1 2)Imamura S, Sagami S, Ishibashi Y, et al : Clinical study [ Analysis ]An open randomized trial comparing of prostaglandin E1 ointment( G-511 ointment )in alcloxa and ointment containing extract from hemoly- chronic skin ulcers. Well-controlled comparative zed blood of young calves( 54 subjects )showed a study with lysozyme chloride ointment. J Clin Ther significantlylarger mean wound reduction rate with Med, 10:127-147, 1994.(LevelⅡ)(Japanese) alcloxa1)(p<0.05). An open randomized trial with 44 3)Robson MC, Phillips LG, Lawrence WT, et al : The subjects comparing alprostadil alfadex and lysozyme safetyand effect of topicallyapplied recombinant hydrochloride found that treatment with the former basic fibroblast growth factor on the healing of resulted in a significantlygreater reduction ratio in chronic pressure sores. Ann Surg, 216(4):401-408, wound size(p<0.05)1). 1992.(LevelⅡ) Similarly, an open randomized trial with 54 subjects 4)Niimura M, Yamamoto K, Kishimoto S, et al : Clinical comparing aluminum chlorohydroxy allantoinate and evaluation of DT-5621 in patients with chronic skin ointment containing extract from the hemolyzed ulcer : A multicenter, placebo-controlled double blind blood of calves found that treatment with the former study. Jpn Pharmacol Ther, 18(7):2757-2770, 1990. resulted in a significantlygreater reduction in wound (LevelⅡ)(Japanese) size(p<0.05)2). Trafermin produced a significantly 5)Ishibashi Y, Soeda S, Ohura T, et al : Clinical effects of greater reduction in wound size ratio( p<0. 05 ) KCB-1, a solution of recombinant human basic when compared with a placebo in an open randomized fibroblast growth factor, on skin ulcers : A phaseⅢ trial(n=119)3). A randomized controlled trial com- studywith comparison to sugar and povidone iodine paring bucladesine sodium and macrogol( n=91 ) ointment. J Clin Ther Med, 12(10):2159-2189, 1996.

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(LevelⅡ)(Japanese) povidone-iodine sugar and 31.3% for lysozyme hyd- 6)Niimura M, Ishibashi Y, Imamura S, et al : Clinical rochloride with no significant difference8). In the latter study of dibutyryl cyclic AMP ointment(DT-5621) report, the efficacyrate was 12.5% for povidone-iodine on chronic skin ulcers. Well-controlled comparative sugar and 23.1% for ointment containing extract from study with lysozyme ointment. J Clin Ther Med, 7 hemolyzed blood of young calves with no significant (3):667-692, 1991.(LevelⅡ)(Japanese) difference9). Further, a retrospective studyof cases showing a reduction in DESIGN scores following CQ1. 15:Which external medications are recom- povidone-iodine sugar treatment failed to indicate any mended if necrotic tissue is observed? correlation between tissue debridement and decrease [Recommendation]Cadexomer-iodine, silver sulfa- in DESIGN score10). diazine, dextranomer, bromelain, povidone-iodine Concerning iodoform, there has been one study sugar or iodoform maybe considered. comparing its wound debridement efficacywith that [Rating]C1 of an existing external drug. Significantlyhigher [ Analysis ]The wound debridement efficacy of efficacywas observed with iodoform compared with cadexomer-iodine, fibrinolysin-deoxyribonuclease, de- the existing external drug(p<0.001)11). The study xtranomer, and dextrin polymer( base )has been also ascribed the wound debridement efficacyof documented in a controlled studywhich reported a iodoform to degradation of typeⅠ collagen. significantlygreater improvement rate( p>0.01)of Thus, as external medications to be used when 45. 5% for cadexomer-iodine in comparison with there is necrotic tissue, the recommendation levels of fibrinolysin-deoxyribonuclease(18.8%)1). A compari- cadexomer-iodine, silver sulfadiazine, dextranomer, son of cadexomer-iodine with dextranomer showed an bromelain, povidone-iodine sugar, and iodoform were efficacyrate of 71.4% and 45.5%, respectively,with no rated as C1. significant difference observed between these two References agents2). Likewise a comparison of dextrin polymer (base)showed an efficacyrate of 8.3% and 26.7%, 1)Kukita A, Ohura T, Aoki T, et al : Clinical evaluation respectively, and no significant difference between of NI-009 on various cutaneous ulcers : Comparative the two was observed3). studywith Elase-C Ointment. J Clin Ther Med, 6 At present the use of silver sulfadiazine for wound (4):817-848, 1990.(LevelⅡ)(Japanese) debridement is endorsed onlybyexpert opinion. As 2)Ishibashi Y, Ohkawara A, Kukita A, et al : Clinical yet there are no studies endorsing its use for this evaluation of NI-009 on various cutaneous ulcers : purpose. Comparative studywith Debrisan. J Clin Ther Med, 6 The abilityof the emulsion base to penetrate the (4):785-816, 1990.(LevelⅡ)(Japanese) skin and to soften and fuse necrotic tissue largely 3)Anzai T, Shiratori A, Ohtomo E, et al : Evaluation of accounts for the wound-cleaning effects of silver clinical utilityof NI-009 in the treatment of various sulfadiazine4). cutaneous ulcers : Comparative studywith base. J A case report comparing the effectiveness of Clin Ther Med, 5(12):2585-2612, 1989.(LevelⅡ) dextranomer with that of bromelain in debriding (Japanese) necrotic tissue indicated a reduction in the number of 4)Tachibana T, Miyachi Y : Drug therapy. Jpn J Plast cases of tissue necrosis from six cases to one5). Two Surg, 46(5):459-470, 2003.(LevelⅥ)(Japanese) separate studies have reported a moderate to high 5)Horio T, Kawai S, Moriguchi T, et al : Therapeutic level of wound debridement efficacyof 57% and 72.5% effects of SK-P-9701(dextranomer paste)on press- for bromelain6, 7). ure ulcers. Jpn J PU, 3(3):355-364, 2001.(LevelⅤ) There have been two reports that evaluated the (Japanese, English abstract) wound debridement efficacyof povidone-iodine sugar, 6)Ogawa Y, Kurooka S, Katakami S, et al:The one comparing it with that of lysozyme hydrochloride evaluation of the effect of bromelain ointment on the and the other comparing it with ointment containing debridement of eschar in burn, decubitus and various extract from hemolyzed blood of young calves. In the wound. J New Rem & Clin, 48(10):1301-1309, 1999. former report, the efficacyrate was 34. 2% for (LevelⅤ)(Japanese)

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7)Kawai S : Report on the clinical experience of using the results were not significantlydifferent from that bromelain ointment on pressure ulcers. J New Rem of the comparison group2). Clin, 52(8):1210-1216, 2003.(LevelⅤ)(Japanese) At present, the use of tretinoin tocoferil is endorsed 8)Imamura S, Uchino H, Imura Y, et al:The clinical onlybyan expert opinion. effect of KT-136( sugar and povidone-iodine oint- In summary, povidone-iodine sugar is indicated for ment)on decubitus and skin, ulcers : A comparison the treatment of cases with a pocket(undermining) with lysozyme ointment. Jpn Pharmacol Ther, 17 and a large amount of exudate, while tretinoin (1):255-279, 1989.(LevelⅡ)(Japanese) tocoferil is indicated for cases with low amounts of 9)KT-136 Skin Ulcers Comparative StudyGroup: exudate. Comparative clinical studyof sugar and povidone- References iodine ointment( KT-136 )and solcoseryl ointment ( SS-094 Ointment ). Jpn Pharmacol Ther, 17( 4 ): 1)Miyachi Y, Kawamori R : Pressure ulcers complicated 1789-1813, 1994.(LevelⅡ)(Japanese) bydiabetes mellitus : Evaluation of U-PASTA KOWA 10)Kobayashi A, Muto S, Chino K, et al : Analysis of the ointment on skin ulcers. Acta Dermatologica, 93: therapeutic effectiveness of a topical agent in the 239-248, 1998.(LevelⅤ)(Japanese) treatment of pressure ulcers using DESIGN Tool. Jpn 2)Robson MC, Phillips LG, Lawrence WT, et al : The JPU, 10(2):111-116, 2008.(LevelⅤ)(Japanese, safetyand effect of topicallyapplied recombinant English abstract) basic fibroblast growth factor on the healing of 11)Mizokami F, Murasawa Y, Furuta K, et al : Iodoform chronic pressure sores. Ann Surg, 216(4):401-408, gauze removes necrotic tissue from pressure ulcer 1992.(LevelⅡ) wounds by fibrinolytic activity. Biol Pharm Bull, 35 (7):1048-1053, 2012.(LevelⅣ) CQ 2 Dressings CQ 2.1:Which dressings are recommended to treat CQ 1.16:Which external medications are recom- acute pressure ulcers? mended when undermining has occurred? [Recommendation]In order to protect the wound [Recommendation]If the undermining is covered surface while allowing dailymonitoring of the bynecrotic tissue, the wound surfaces should first be condition, transparent film dressings or dressings cleaned. Also, if there is excessive exudate, povidone designed to treat dermal wounds maybe used. iodine-sugar maybe used. If the amount of exudation [Rating]C1 is minimal, consider using trafermin or tretinoin [Analysis]Recommendations for the use of dres- tocoferil. sings to treat acute phase pressure ulcers are [Rating]C1 supported onlybyexpert opinion 1). It is important to [Analysis]There are a limited number of refer- determine the cause of acute phase pressure ulcers. ences dealing with the application of external Since the condition of tissue localized in and around medications on pressure ulcers which list undermin- acute phase pressure ulcers has a propensityto ing among their assessment categories. In general, worsen rapidly, frequent and regular monitoring of however, in cases in which a undermining is found, all the wound condition is vital. For this reason, a necrotic tissue should be removed from its interior transparent dressing which will allow visual monitor- and the wound surface cleansed. Caution needs to be ing is recommended. exercised to prevent the occasional secondaryinfec- Transparent film dressings are recommended for tion. the protection of erythematous areas from friction or A case-series on the efficacyof povidone-iodine shear. Before applying the transparent film dressing, sugar with undermining as one of its evaluation items cleanse the skin where the dressing is to be applied. If has demonstrated the ameliorative effect of the there are anynoticeable changes to the wound compound1). condition, replace the dressing with a new one. As a Although a case-control studywith an evidence rule dressings should be changed at a frequencyof level of Ⅳ examining the effect of trafermin on once per week. undermining has demonstrated an ameliorative effect,

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once per week. Continue visual monitoring of the References redness or purpura through the dressing. If the tissue 1)Kawakami S, Shimada K : The treatment of acute damage progressed from the epidermis to the dermis, phase pressure ulcer. Modern Physician, 28( 4 ): change treatment for erosion or shallow ulcers. Again, 506-507, 2008.(LevelⅥ)(Japanese) in order to ensure that these steps can be taken when necessary, a transparent dressing which allows visual CQ 2.2:Which dressings are indicated in pressure monitoring is highlyrecommended. ulcers with suspected deep tissue injury(DTI)? References [Recommendation]In order to protect the wound surface while allowing dailymonitoring of the 1)Itou T, Takahashi R, Suzuki C, et al : The use of condition, either transparent film dressings or dres- hydrocolloid dressing in the treatment of pressure sings designed to treat dermal wounds maybe ulcer. Jpn J Nur Sci, 20(12):75-80, 1995.(LevelⅤ) considered. (Japanese) [Rating]C1 [ Analysis ]There are no studies examining the CQ 2. 4:Which dressings are recommended for efficacyof dressings on the treatment of deep tissue cases involving blistering? injuries(DTI). Because DTI tends to progress more [Recommendation]While leaving the blisters in- deeplyinto underlyingtissue, frequent monitoring of tact, consider using a transparent film dressing to the wound is vital. For this reason, a transparent protect the wound surface. A dressing for dermal dressing that will allow observation of the wound wounds that allows observation mayalso be consi- condition is recommended. Transparent film dres- dered. sings are recommended for the protection of erythe- [Rating]C1 matous areas from friction or shear. Before applying [ Analysis ]The use of dressings for blisters is the polyurethane dressing, cleanse the skin where the supported onlybyexpert opinion 1). A transparent film dressing is to be applied. If there are anynoticeable dressing is recommended for the protection of changes in the condition of the wound, replace the blistering areas from friction or shear. Before applying dressing with a new one. As a rule dressings should be the transparent film dressing, cleanse the skin where changed at a frequencyof once per week. the dressing is to be applied. As a rule dressings should be changed at least once per week. If the CQ 2. 3:Which dressings are recommended for blisters are tense, theymaybe punctured and drained pressure ulcers involving redness/purpura? to relieve pressure1). If the blisters are ruptured and [Recommendation]In order to protect the wound the wound begins to penetrate to the dermis, switch surface while allowing dailymonitoring of the to a treatment for erosion or shallow ulcers. Again, in condition, either transparent film dressings or dres- order to ensure that these steps can be taken when sings designed to treat dermal wounds maybe necessary, a transparent dressing which allows visual considered. monitoring is highlyrecommended. [Rating]C1 References [Analysis]There are ten Evidence Level V case reports documenting the use of hydrocolloid for the 1)Kishinabe M : How to treat blister?, Guideline for local treatment of redness. However, these case reports do treatment of pressure ulcers. Miyachi Y, Sanada H ed, not deal specificallywith pressure ulcers with the 145-149, Medical Review Co., Ltd, Tokyo, 2007.(Level redness/purpura, but also include discussion of Ⅵ)(Japanese) pressure ulcers at other stages, and therefore do not specificallyaddress the efficacyof hydrocolloidin the CQ 2. 5:Which dressings are recommended for treatment of redness/purpura1). treating erosions or shallow ulcers? Before applying the transparent film dressing, [Recommendation] cleanse the skin where the dressing is to be applied. 1.A health insurance-covered hydrocolloid dres- The dressing should be changed at a frequencyof sing used to treat dermal wounds is recommended. A

―G−29― ― 484 ― hydrocolloid dressing used to treat subcutaneous ・Hydropolymer : One randomized controlled trial6) wounds is also an option, but is not covered byhealth examined the efficacy of hydropolymer on healing insurance. rate. In a comparison of hydropolymer with hydrocol- [Rating]B loid using stageⅡ and Ⅲ pressure ulcers, the study [Recommendation] found no significant difference in healing time or 2.Health insurance-covered dressings designed to healing rate. As the studywas designed as a treat dermal wounds, such as hydrogel, polyurethane superioritytrial, we cannot be certain that the efficacy foam sheets, alginate foam dressing, and chitin of the hydropolymer was equal to that of the membrane maybe considered. Dressings designed to hydrocolloid. treat subcutaneous wounds, such as hydrogel, hyd- For this reason the methods discussed here have ropolymer, polyurethane foam, polyurethane foam/ been assigned the recommendation rating of C1. soft silicone, alginate, and chitin membrane can also be ・Polyurethane foam : There are two randomized employed with equal effect, but are not covered by controlled trials comparing the healing rate using health insurance. polyurethane foam7, 8). The trial that compared the [Rating]C1 healing rate of stageⅡ pressure ulcers with that using [Analysis] saline gauze dressings7) showed no significant differ- ・Hydrocolloid : Two systematic reviews1, 2)and one ence in the time required for wound closure but meta-analysis3)have examined the use of hydrocolloid significantlylower frequencyof dressing changes for the topical treatment of pressure ulcers. One (p<0.001). The trial that compared the healing rate of systematic review1)found hydrocolloids to be superior stageⅡ pressure ulcers with that using to wet-to-moist saline gauze dressings in terms of hydrocolloids8), the contribution of polyurethane foam wound size reduction, absorption of exudates, fre- to healing and cost was at least 10% greater, but the quencyof replacement, pain felt when dressing is difference was not significant. Therefore, it was rated changed, side effects, and cost, but stageⅢ pressure as C1. ulcers are included in the study. In another systematic ・Polyurethane foam/soft silicone : One rando- review2), hydrocolloids were superior to wet-to-moist mized controlled trial examined the recoveryrate in saline gauze dressing in wound size reduction, but as stage II pressure ulcers after use of polyurethane stageⅢ pressure ulcers were included in the treated foam dressings but found no significant difference lesions, discussion of the efficacyof hydrocolloidsin with the use of hydropolymer dressing9). For this treating erosions and shallow ulcers maynot be reason, polyurethane foam/soft silicone dressing has relevant. The meta-analysis3) found hydrocolloid 72% been given a recommendation rating of C1. more effective(odds ratio : 1.72)than wet-to-moist ・Alginate foam, chitin membrane, and alginate : No gauze or paraffin-gauze dressings, but omits any studies addressing the use of these dressings on discussion of the depth of the wounds observed in the erosions and shallow ulcers exist. Recommendations study. Because the specific relevance of these results for their use are supported onlybyexpert opinion. to erosions and shallow ulcers is not clear, the References methods described here have been assigned the recommendation rating of B. 1)Heyneman A, Beele H, Vanderwee K, et al : A ・Hydrogel : Two randomized controlled trials have systematic review of the use of hydorocolloids in the examined the healing rate following use of various treatment of pressure ulcers. J Clin Nurs, 17(9): dressings4, 5). These studies found no significant 1164-1173, 2008.(LevelⅠ) difference in efficacybetween wet-to-moist gauze 2)Smith ME, Totten A, Hickam DH, et al : Pressure dressings and hydrocolloids. Furthermore, as the ulcer treatment strategies : a systematic comparative studyincluded stageⅢ and Ⅳ pressure ulcers, the effectiveness. Ann Intern Med, 159(1):39-50, 2013. specific relevance of the findings to cases of erosions (LevelⅠ) and shallow ulcers remains unclear. For this reason, 3)Singh A, Haler S, Menon GR, et al : Meta-analysis of the methods discussed here have been assigned the randomized controlled trials on hydrocolloid occlusive recommendation rating of C1. dressing vs conventional gauze dressing in the

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healing of chronic wounds. Asian J Surg, 27( 4 ): removed carefully. 326-332, 2004.(LevelⅠ) [Rating]C1 4)Thomas DR, Goode PS, LaMaster K, et al : Aceman- [Analysis] nan hydrogel dressing versus saline dressing for ・Hydrocolloid : There is one systematic review pressure ulcers. Adv Wound Care, 11(6):273-276, evaluating the effect of hydrocolloid on pain associ- 1998.(LevelⅡ) ated with pressure ulcer1). Among the studies covered 5)Thomas S, Banks V, Bale S, et al : A comparison of two bythis review, the relationship between the dressing dressings in the management of chronic wounds. J material and pain is mentioned in onlyone cross- Wound Care, 6(8):383-386, 1997.(LevelⅡ) sectional study2), in which hydrocolloid was signifi- 6)Mulder GD, Altman M, SeeleyJE, et al : Prospective cantlymore effective for mitigating pain than saline randomized studyof the efficacyof hydrogel, gauze dressing or polyurethane film(p<0.02). Also, hydrocolloid, and saline solution-moistened dressings as hydrocolloid produces its pain-mitigating effect by on the management of pressure ulcers. Wound Repair creating a occluded, moist environment3, 4)it mayalso Regen, 1(4):213-218, 1993.(LevelⅡ) be used for reducing pain during dressing change. 7)Payne WG, Posnett J, Alvarez O, et al : A prospective, Therefore, it was rated as C1. randomized clinical trial to assess the cost- ・According to a systematic review5) and a effectiveness of a modern foam dressing versus a randomized controlled trial6)comparing the efficacyof traditional saline gauze dressing in the treatment of saline gauze dressings and hydrocolloid in reducing stageⅡ pressure ulcers. OstomyWound Manage, 55 pain during dressing change, pain during dressing (2):50-55, 2009.(LevelⅡ) change was significantlymitigated byhydrocolloid 8)Guillén-Solà M, Soler Mieras A, Tomàs-Vidal AM, et compared with saline gauze dressing( p<0. 001 )6). al : A multi-center, randomized, clinical trial compar- Regarding comparison of hydrocolloid with other ing adhesive polyurethane foam dressing and adhe- dressing materials, the systematic review5) reported sive hydrocolloid dressing in patients with grade 2 that hydrocolloid was significantly inferior to alginate pressure ulcers in primarycare and nursing homes. or polyurethane foam. Another systematic review1) BMC FamilyPractice, 14:196, 2013.(LevelⅡ) reported that dressing change was painful without 9)Maume S, Van De Looverbosch D, Heyman H, et al : A specifying the dressing materials. Therefore, hydro- studyto compare a new self-adherent soft silicone colloid was rated as C1. However, when hydrocolloid dressing with a self-adherent polymer dressing in is used on delicate skin, it must be removed carefully stageⅡ pressure ulcers. OstomyWound Manage, 49 to prevent damage to the skin. (9):44-51, 2003.(LevelⅡ) ・Polyurethane foam : There are two randomized controlled studies that evaluated the effect of CQ 2. 6:Which dressings are recommended for polyurethane foam on pain associated with pressure pressure ulcers involving pain? ulcers7, 8). One reported that pain during dressing [Recommendation] change was milder with polyurethane foam than with 1.Dressings cannot remove pain but can lessen it hydrocolloid(p<0.005)7), but the other studyshowed byprotecting the wound surface and maintaining a no significant difference in the degree of discomfort moist environment conducive to wound healing. compared with the concomitant use of saline gauze When changing dressings, perform adequate pain dressing and polyurethane film8). Therefore, assessment and apply a hydrocolloid, polyurethane polyurethane foam was rated as C1. Concerning pain foam/soft silicone, Hydrofiber®, Hydrofiber® /hydro- during change of polyurethane foam, there are 3 colloid, chitin membrane, or hydrogel. randomized controlled trials7−9). One reported that [Rating]C1 pain during dressing change was milder compared 2.For mitigating pain during dressing change, with hydrocolloid(p<0.005)but that there was no alginate, polyurethane foam, polyurethane foam/soft difference in pain during removal compared with the silicone, hydrocolloid, Hydrofiber®, and Hydrofiber®/ concomitant use of saline gauze and polyurethane hydrocolloid may also be used. However, when film8). According to a randomized controlled trial hydrocolloid is used on delicate skin, it must be comparing the concomitant use of polyurethane foam

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and hydrocolloid with other dressing materials9), pain trial that evaluated the effect of alginate on pain during dressing change was significantlymilder with during dressing change15). When a combination of silver-containing polyurethane foam than with other alginate and hydrocolloid was compared with other dressing materials(alginate foam, hydrocolloid, etc.) dressing materials, pain was significantlymilder in the (p=0.0055). Therefore, polyurethane foam was rated group treated with the combination of alginate and as C1. hydrocolloid than in the group treated with hydrocol- ・Polyurethane foam/soft silicone : There is one loid alone( p<0. 03 )15). Therefore, the material was each randomized controlled trial10), non-randomized rated as C1. controlled trial11), analytical epidemiological study12), ・Chitin : One case report examined the analgesic and case report13) evaluating pain associated with effect of chitin dressings in 32 patients and found that pressure ulcer. In the randomized controlled trial10), of the 19 patients who were successfullyassessed, 15 significant differences were observed in tissue dam- reported less pain when dressings were being age during dressing change after 1, 2 and 3 weeks changed16). However, no statistical data have been compared with hydropolymer(p<0.05), and while offered in the studyto corroborate this claim. polyurethane foam/soft silicone was reported to be Therefore, the material was rated as C1. more readilyremovable, there was no mention about References pain. According to the non-randomized controlled study11), in which pain during change of polyurethane 1)Pieper B, Langemo D, Cuddigan J : Pressure ulcer foam/soft silicone was quantitativelyevaluated, the pain:Asystematic literature review and national pain score was significantlylower for polyurethane pressure ulcer advisorypanel white paper. Ostomy foam/soft silicone(1.43)than for conventional dres- Wound Manage, 55(2):16-31, 2009.(LevelⅠ) sing materials such as hydrocolloid and polyurethane 2)Dallam L, Smyth C, Jackson BS, et al : Pressure ulcer foam(3.88)(p<0.05). However, whether or not the pain : assessment and quantification. J Wound treated chronic wounds included pressure ulcers is OstomyContinence Nurs, 22(5):211-215, 1995. unclear. According to the analytical epidemiological 3)Hashizume K, Kitaya R, Tsurumi M, et al : Clinical study12), polyurethane foam/soft silicone was signifi- effect of occlusive dressing Comfeel on decubitus. J cantlysuperior to conventional dressing materials New Rem Clin, 46(10):1348-1360, 1997.(LevelⅤ) (foam with adhesive, hydrocolloid)in mitigation of (Japanese) pain during the application of dressing and pain 4)Asakura K, Takahashi R, Suzuki C, et al : Utilityof during dressing change( p=0. 01 ), but pressure occlusive dressing Comfeel on decubitus. Jpn J Med ulcers accounted for 13% of the treated wounds. In the Pharm Sci, 33( 1 ):87-200, 1995.( LevelⅤ ) case report that evaluated pain during the use of (Japanese) dressing materials13), 93% of the patients felt no pain 5)Heyneman A, Beele H, Vanderwee K, et al : A during removal, and all patients were satisfied with systematic review of the use of hydorocolloids in the polyurethane foam/soft silicone, but the treated treatment of pressure ulcers. J Clin Nurs, 17(9): wounds included non-diabetic and diabetic ulcers of 1164-1173, 2008.(LevelⅠ) the lower leg. Therefore, the material was rated as C1 6)Chang KW, Alsagoff S, Ong K, et al : Pressure ulcers− in all these respects. randomised controlled trial comparing hydrocolloid ・Hydrofiber® : There is one case report in which and saline gauze dressings. Med J Malaysia, 53(4): the effects of Hydrofiber® on pain associated with 428-431, 1998.(LevelⅡ) pressure ulcer and pain during dressing change were 7)Banks V, Bale S, Harding K : The use of two dressings evaluated14). Pain was reported to be reduced, and for moderatelyexuding pressure sores. J Wound secondarydamage during dressing change to be Care, 3(3):132-134, 1994.(LevelⅡ) prevented, in 90% or more of stageⅡ−Ⅳ pressure 8)Banks V, Bale S, Harding K : Superficial pressure ulcers, but there was no comparison with other sores : comparing two regimens. J Wound Care, 3 dressing materials. Therefore, the material was rated (1):8-10, 1994.(LevelⅡ) as C1 in all these respects. 9)Munter KC, Beele H, Russell L, et al : Effect of a ・Alginate : There is one randomized controlled sustained silver-releasing dressing on ulcers with

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delayed healing : the CONTOP study. J Wound Care, On the other hand, alginate/CMC(carboxymethyl- 15(5):199-206, 2006.(LevelⅡ) cellulose ), polyurethane foam/soft silicone, alginate, 10)Maume S, Van De Looverbosch D, Heyman H, et al: chitin membrane, Hydrofiber®, and hydropolymer, are A studyto compare a new self-adherent soft silicone not discussed in anyhigh-evidence level studies and dressing with a self-adherent polymer dressing in so theyhave been assigned the recommendation stageⅡ pressure ulcers. OstomyWound Manage, 49 rating of C1. (9):44-51, 2003.(LevelⅡ) Beele et al. examined the effect of silver-containing 11)Upton D, Solowiej K : The impact of atraumatic vs alginate/CMC and non-silver-containing alginate/ conventional dressings on pain and stress. J Wound CMC in a randomized controlled trial using 36 Care, 21(5):209-215, 2012.(LevelⅢ) patients with moderate to high levels of exudates 12)White R : A multinational surveyof the assessment of from pressure ulcers or varicose ulcers and found pain when removing dressing. Wounds UK, 4(1): significantlyhigher level of wound-size reduction in 14-22, 2008.(LevelⅣ) patients treated with silver-containing alginate dres- 13)Hurd T, GregoryJ, Jones A, et al:A multi-centre in- sings(p=0.017)3). However, due to the fact that this market evaluation of ALLEVYN Gentle Border. studyfails to assess the capacityof these dressings to Wounds UK, 5(3):32-44, 2009.(LevelⅤ) absorb exudates, the methods discussed here have 14)Parish LC, Dryjski M, Cadden S, et al : Prospective been assigned a recommendation rating of C1. clinical studyof a new adhesive gelling foam dressing A randomized controlled trial4). compared the in pressure ulcers. Int Wound J, 5(1):60-67, 2008. ability of polyurethane foam/soft silicone and hyd- (LevelⅤ) ropolymer to absorb exudates and found that while 16)Ueyama T : Treatment of the decubitus bythe there was no statistical difference in absorptive flocculent chitin. J New Rem Clin, 43(2):291-299, capacitybetween these two typesof dressing, 1994.(LevelⅤ)(Japanese) polyurethane foam/soft silicone dressings were super- ior in preventing damage and maceration to skin in CQ 2. 7:Which dressings are recommended in the wound periphery(p<0.05). Because there was pressure ulcers with excessive exudate? no difference in the absorptive capacityof these [Recommendation] dressings, their use has been assigned the recom- 1.Recommend using polyurethane foam dressings, mendation rating of C1. which can absorb excess exudates. The use of alginate, alginate foam, chitin membrane [Rating]B Hydrofiber®, and hydropolymer dressings is addres- [Recommendation] sed onlyin case reports ; recommendation rating : 2.Dressings normallyused for subcutaneous C15−10). wounds as well as dressings used to treat deeper References wounds involving muscle and bone, such as alginate/ CMC, polyurethane foam/soft silicone dressings, 1)Heyneman A, Beele H, Vanderwee K, et al : A alginate, alginate foam, chitin membrane, Hydrofiber®, systematic review of the use of hydrocolloids in the Hydrofiber® /hydrocolloids, or hydropolymer dres- treatment of pressure ulcers. J Clin Nurs, 17(9): sings, maybe applied. 1164-1173, 2008.(LevelⅠ) [Rating]C1 2)Bale S, Squires D, Varnon T, et al : A comparison of [ Analysis ]The one systematic review1) which two dressings in pressure sore management. J Wound discusses the use of polyurethane foam dressings does Care, 6(10):463-466, 1997.(LevelⅡ) not mention its efficacyin absorbing exudates as an 3)Beele H, Meuleneire F, Nahuys M, et al : A prospec- outcome. Nonetheless, a randomized controlled trial2) tive randomized open label studyto evaluate the found that polyurethane foam was significantly more potential of a new silver alginate/carboxymethylcel- effective(p<0.001)in absorbing exudates than hyd- lulose antimicrobial wound dressing to promote rocolloids, and for this reason the use of polyurethane wound healing. Int Wound J, 7( 4 ):262-270, 2010. foam has been assigned the recommendation rating of (LevelⅡ) B. 4)Maume S, Van De Looverbosch D, Heyman H, et al : A

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studyto compare a new self-adherent soft silicone saline gauze dressings and hydrocolloid dressings dressing with a self-adherent polymer dressing in failed to show a significant difference in this regard. stageⅡ pressure ulcers. OstomyWound Manage, 49 While the studydeals with the treatment of stageⅡ-Ⅳ (9):44-51, 2003.(LevelⅡ) pressure ulcers, it does not address the efficacyof 5)Harada S, Nakanishi H, Kawabata Y : Clinical Evalua- hydrogel dressings for the treatment of pressure tion of SORBSAN(Calcium alginate fiber dressing) ulcers with low amounts of exudates and therefore for the treatment of skin ulcer. J New Rem Clin, 10 merits a recommendation rating of onlyC1. (2):473-495, 1994.(LevelⅤ)(Japanese) References 6)Tsukada K : Usefulness of sponge-type alginate gel dressing on tissue granulation of pressure ulcers. Jpn 1)Singh A, Haler S, Menon GR, et al : Meta-analysis of JPU, 5(1):27-32, 2003.(LevelⅤ)(Japanese, En- randomized controlled trials on hydrocolloid occlusive glish abstract) dressing vs conventional gauze dressing in the 7)Ueyama T : Treatment of the decubitus bythe healing of chronic wounds. Asian J Surg, 27( 4 ): flocculent chitin. J New Rem Clin, 43(2):291-299, 326-332, 2004.(LevelⅠ) 1994.(LevelⅤ)(Japanese) 2)Thomas DR, Goode PS, LaMaster K, et al : Aceman- 8)Coutts P, Sibbald R : The effect of a silver-containing nan hydrogel dressing versus saline dressing for Hydrofiber® dressing on superficial wound bed and pressure ulcers. Adv Wound Care, 11(6):273-276, bacterial balance of chronic wounds. Int Wound J, 2 1998.(LevelⅡ) (4):348-356, 2005.(LevelⅤ) 3)Mulder GD, Altman M, SeeleyJE, et al:Prospective 9)Parish LC, Dryjski M, Cadden S : Prospective clinical randomized studyof the efficacyof hydrogel, studyof a new adhesive Gelling foam dressing in hydrocolloid, and saline solution-moistened dressings pressure ulcers. Int Wound J, 5( 1 ):60-67, 2008. on the management of pressure ulcers. Wound Repair (LevelⅤ) Regen, 1(4):213-218, 1993.(LevelⅢ) 10)Ohura T : Clinical experience with a new hydropo- lymer dressing. Jpn JPU, 4( 1 ):105-110, 2002. CQ 2. 9:Which dressings are recommended for (LevelⅤ)(Japanese, English abstract) infected and inflamed pressure ulcers? [Recommendation] CQ 2. 8:Which dressings are recommended for 1.Consider using topical agents to suppress pressure ulcers with minimal amounts of exudates? infection. Alternatively, silver-containing Hydrofiber® [Recommendation] or alginate silver maybe used. 1.Using a hydrocolloid dressing is recommended. [Rating]C1 [Rating]B 2.Alginate is sometimes used to dress wounds [Recommendation] with excessive exudates because of its superior 2.Using a hydrogel may be considered. absorptive ability, but cannot be recommended here [Rating]C1 due to its inabilityto suppress infection. [Analysis] [Rating]C2 ・Hydrocolloid : One meta-analysis exists addres- [Analysis]One systematic review1) has addressed sing the use of hydrocolloid dressing for local the use of silver-containing Hydrofiber® in the context treatment of pressure ulcers1). In this study, hydrocol- of wound infection and inflammation. In 26 rando- loid was found to be 72% more effective in healing mized controlled trials dealing with the use of silver in pressure ulcers than conventional saline gauze the localized treatment of acute phase and chronically dressings or paraffin-gauze dressings(odds ratio: 1. contaminated and infected wounds failed to detect a 72). However, as no mention is made of the capacityof significant difference in the infection rate as an each type of dressing to absorb exudates, the outcome. Due to this observation, it was concluded recommendation merits a level of B. that there is inadequate evidence to support the use of Hydrogel : Two randomized controlled trials have silver as a means of suppressing infection. Further, examined the efficacyof hydrogelin promoting even in their systematic review, which documents the granulation tissue formation2, 3), but a comparison with efficacyof silver in the treatment of infected wounds,

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Toyand Macera state that there is insufficient alginate5). On the basis of the reports, we may evidence to endorse the use of silver-containing foam conclude that although alginate is sometimes used for dressings or external medications to treat chronically its superior abilityto absorb exudates, it has no contaminated and infected wounds2). demonstrable abilityto suppress wound infection and Three randomized controlled trials have addressed therefore cannot be recommended. the use of silver alginate to suppress infection in References pressure ulcers3−5). The studies found that silver- containing alginate/CMC not onlyresulted in a 1)Storm-Versloot MN, Vos CG, Ubbink DT, et al : greater reduction in wound size than non-silver- Topical silver for preventing wound infection, containing alginate/CMC,( p=0. 017 ), but also in a Cochrane Wounds Group, Cochrane Database of significantlybetter healing rate four weeks into Systematic Reviews 2010, Issue 3. Art.(LevelⅠ) treatment(p=0.044). On the basis of these findings, 2)ToyLW, Macer a L : Evidence-based review of silver it was concluded that silver-containing alginate/CMC dressing use on chronic wounds. J Am Acad Nurse has a significantlygreater effect on promoting healing Pract, 23(4):183-192, 2011.(Level Ⅰ) in pressure ulcers and suppressing infection. On the 3)Beele H, Meuleneire F, Nahuys M, et al : A prospec- other hand, other studies report disparate results, tive randomized open label studyto evaluate the with Trial et al. claiming that a comparison of alginate potential of a new silver alginate/carboxymethylcel- and silver-containing alginate failed to show any lulose antimicrobial wound dressing to promote difference in the clinical scores for infection4), and wound healing. Int Wound J, 7( 4 ):262-270, 2010. Meaume et al. claiming that while there was no (LevelⅡ) statisticallysignificant difference in wound infection 4)Trial C, Darbas H, Lavigne JP, et al : Assessment of rate after use of silver-containing alginate(33%)and the antimicrobial effectiveness of a new silver alginate alginate(46%), the healing rate for silver-containing wound dressing : a RCT. J Wound Care, 19(1):20- alginate was appreciablyhigher( p=0.024)5).Onthe 26, 2010.(LevelⅡ) basis of these findings, silver-containing Hydrofiber® 5)Meaume S, Vallet D, Morere MN, et al : Evaluation of a or silver alginate maybe used to treat infected or silver-releasing hydroalginate dressing in chronic inflamed wounds. However, when the evidence from wounds with signs of local infection. J Wound Care, 14 the systematic reviews1, 2) is taken into account, it is (9):411-419, 2005.(LevelⅡ) clear that the use of these dressings to treat infected wounds is not supported byadequate evidence. In CQ 2. 10:Which dressing materials are recom- addition, because of the unavailabilityin Japan, and mended when delayed wound healing is suspected in varying silver content, of some of the products the granulation period due to critical colonization? examined in the aforementioned studies, the abilityof [ Recommendation ]Consider using silver- these dressings to suppress infections cannot be containing Hydrofiber® or alginate silver. clearlyassessed. Therefore the methods discussed [Rating]C1 here have been assigned the recommendation rating [Analysis]A systematic review using indications of C1. of critical colonization as a measure compared the Alginate is sometimes used for its superior absorp- effect of silver-containing Hydrofiber® and other types tive qualities to treat pressure ulcers with large of dressing on wound size reduction and healing rate1). quantities of exudates. However, as it has no However, this studyfailed to arrive at anyconclusions demonstrable abilityto suppress infection, its use is regarding pressure ulcers where critical colonization not recommended. was suspected due to insufficient granulation tissue One randomized controlled trial examined the use formation. Of the randomized controlled trials discus- of alginate on infected wounds5). The studyfound that sed in the systematic review2), although significant in 71 cases of varicose ulcer and 28 cases of pressure reductions in wound size were reported(p=0.0019), ulcer all requiring infection suppression, no difference only8% of the subjects enrolled were pressure ulcer in result was seen in wound infection rate between the patients. There is also one randomized controlled trial groups treated with alginate and silver-containing examining the effect of alginate silver on varicose

―G−35― ― 490 ― ulcers requiring infection suppression and pressure Hydrofiber®, and Hydrofiber® /hydrocolloids may be ulcers3). In a comparison of silver-containing alginate considered. and non-silver-containing alginate on 24 cases of [Rating]C1 varicose ulcer in the critical colonization phase or at [Analysis] risk of infection and 12 cases of pressure ulcer, the *Alginate silver:There is one systematic review studyfound that while there was no exacerbation of examining the use of silver-containing dressings1)and infection in either group, significantlygreater reduc- two randomized controlled studies examining the use tions in wound size were achieved in the alginate of alginate silver or alginate to treat pressure ulcers2, 3). silver group( p=0. 017 ). In addition, there is one The systematic review does not draw any conclusions randomized controlled trial that evaluated the anti- regarding the efficacyof silver-containing dressings in bacterial effect of alginate silver in wounds im- promoting granulation tissue formation. In the rando- mediatelyafter debridement, in which the bacterial mized controlled trial that compared the wound size load is likelyto increase 4). Since the bacterial quantity reduction rate2), wounds treated with hydrocolloid score was significantlylower in wounds treated with after alginate silver and those treated with hydrocol- alginate silver than those treated with non-silver- loid alone were compared, and the wound size containing alginate( p=0. 044 ), alginate silver was reduction rate was significantlyhigher in the wounds concluded to have an antibacterial effect due to silver treated concomitantlywith alginate silver and hydro- ion. colloid( p<0. 01 ). However, the effect of alginate However, because the number of pressure ulcer silver alone was not evaluated. In the randomized patients enrolled was small, and no discussion about controlled trial that compared silver-containing zinc granulation formation in these cases was included, the ointment and alginate silver3), alginate silver was methods discussed here have been assigned a rated as significantlysuperior bywound base tissue recommendation rating of C1. assessment using the PUSH Tool(p<0.001), but it was compared with silver-containing zinc ointment References alone. Therefore, its recommendation level was rated 1)Beam JW : Topical silver for infected wounds. J Athl as C1. Train, 44(5):531-533, 2009.(LevelⅠ) *While there are randomized controlled trials 2)Munter KC, Beele H, Russell L, et al : Effect of a examining the use of hydrocolloid, hydropolymer, sustained silver-releasing dressing on ulcers with polyurethane foam, and polyurethane foam/soft delayed healing : the CONTOP study. J Wound Care, silicone, none of these studies reports on the effect of 15(5):199-206, 2006.(LevelⅡ) these dressings on granulation tissue formation ; 3)Beele H, Meuleneire F, Nahuys M, et al : A prospec- recommendation level : C1. tive randomized open label studyto evaluate the *Chitin and Hydrofiber® are addressed onlyin case potential of a new silver alginate/carboxymethylcel- reports. As the evidence level is low, the recommenda- lulose antimicrobial wound dressing to promote tion rating given is C1. wound healing. Int Wound J, 7( 4 ):262-270, 2010. References (LevelⅡ) 4)Sato T, Ishikawa S, Terabe Y, et al : Silver calcium 1)Carter MJ, Tingley-Kelley K, Warriner RA 3rd : Silver alginate dressings reduce bacterial burden in wounds treatments and silver-impregnated dressings for the after surgical debridement. Jpn JPU,15(2):105-110, healing of leg wounds and ulcers : A systematic 2013.(LevelⅢ) review and meta-analysis. J Am Acad Dermatol, 63 (4):668-679, 2010.(LevelⅠ) CQ 2. 11:Which dressings are recommended for 2)Belmin J, Meaume S, Rabus MT, et al : Investigators promoting granulation tissue formation in pressure of the sequential treatment of the elderlywith ulcers where it is deficient? pressure sores(STEPS)trial. Sequential treatment [Recommendation]Alginate silver, alginate, hyd- with calcium alginate dressings and hydrocolloid rocolloid, hydropolymer, polyurethane foam, dressings accelerates pressure ulcer healing in older polyurethane foam/soft silicone, chitin membrane, subjects : a multicenter randomized trial of sequential

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versus nonsequential treatment with hydrocolloid for the first four weeks, then with a combination of dressings alone. J Am Geriatr Soc, 50(2):269-274, alginate and hydrocolloid for the next four weeks. 2002.(LevelⅡ) Another group was treated for eight weeks with 3)Chuangsuwanich A, Chortrakarnkij P, Kangwan- hydrocolloid alone. A comparison of the results poom J : Cost-effectiveness analysis in comparing indicated greater reductions in wound size for the alginate silver dressing with silver zinc sulfadiazine former(p<0.01). In a case report using alginate and cream in the treatment of pressure ulcers. Arch Plast foam dressing5), the wound size was 12.5±7.5 mm2 at Surg, 40(5):589-596, 2013.(LevelⅡ) the beginning of the studyand 3.7±5.2 m 2 12 weeks after the beginning of treatment using alginate and CQ 2. 12:Which dressings are recommended to foam dressing, showing a significant decrease promote the reduction of the size of wounds with (p<0.001). Accordinglythe methods discussed here adequate/normal granulation tissue formation? have been given the recommendation rating of B. [Recommendation] On the basis of these reports, consider using silver- 1.Using silver-containing Hydrofiber®, alginate containing Hydrofiber®, silver alginate, or alginate silver, or alginate is recommended. when attempting to achieve wound-size reduction in [Rating]B cases with adequate granulation formation. [Recommendation] A systematic review claiming greater efficacy in 2.Hydrocolloid, hydrogel, hydropolymer, wound-size reduction for hydrocolloid in a comparison polyurethane foam, polyurethane foam/soft silicone with saline gauze dressings6) also states that no dressing, alginate foam, chitin membrane, significant difference in efficacywas found in a Hydrofiber®, Hydrofiber®/hydrocolloids, alginate/ comparison of hydrocolloid with alginate, hydrogel, CMC are also options, depending on the amount of and polyurethane foam. For this reason, the use of exudate present. hydrocolloid has been accorded the same recom- [Rating]C1 mendation rating of C1 as the other types of dressing [Analysis]The one systematic review1)examining previouslydiscussed. the effect of silver-containing Hydrofiber® concluded Although a number of randomized controlled trials that while wound reduction could be achieved in the have examined the other types of dressing, including short term, Hydrofiber® could not be recommended hydrogel, hydropolymer, and polyurethane foam, none for promoting wound healing due to the paucityof of these studies documented evidence pertaining to evidence ; recommendation rating B. their efficacyin wound reduction. Polyurethane In their randomized controlled trial, Beale et al. foam/soft silicone, alginate foam, chitin, Hydrofiber®, reported the efficacyof silver alginate on wound-size and aliginate/CMC have been discussed in case reduction, but their comparison of silver-containing reports only; recommendation rating : C1. alginate/CMC and non-silver-containing alginate/ From these reports, anyof the dressings discussed CMC concluded that the use of silver-containing above, namely hydrocolloid, hydrogel, hydropolymer, alginate led to greater reductions in wound size polyurethane foam, polyurethane foam/soft silicone, compared to alginate alone(p=0.017)and therefore alginate foam, chitin, Hydrofiber®, and alginate/CMC to a stronger wound healing effect2). On the basis of can be used according to the amount of exudates. this conclusion, the use of silver-containing alginate References has been assigned a recommendation rating of B. Although the wound reduction effect of alginate is 1)Carter MJ, Tingley-Kelley K, Warriner RA, et al : mentioned in a systematic review by Madhuri et al., Silver treatments and silver-impregnated dressings the studyfailed to offer clear proof of this assertion 3). for the healing of leg wounds and ulcers : A In a randomized controlled trial4), the result of a systematic review and meta-analysis. J Am Acad comparison of alginate and dextranomer paste found Dermatol, 63(4):668-679, 2010.(LevelⅠ) that wounds treated with alginate showed greater 2)Beele H, Meuleneire F, Nahuys M, et al : A prospec- reduction in size. Further, in an eight-week experi- tive randomized open label studyto evaluate the ment one group of subjects was treated with alginate potential of a new silver alginate/ carboxymethylcel-

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lulose antimicrobial wound dressing to promote pressure sores. J Wound Care, 5(10):444-446, 1996. wound healing. Int Wound J, 7( 4 ):262-270, 2010. 2)Parnell LK, Ciufi B, Gokoo CF : Preliminaryuse of a (LevelⅡ) hydrogel containing enzymes in the treatment of 3)Madhuri R, Sudeep S, Rochon P : Treatment of stageⅡ and stageⅢ pressure ulcers. OstomyWound pressure ulcers:Asystematic review. JAMA, 300 Manage, 51(8):50-60, 2005. (22):2647-2662, 2008.(LevelⅠ) 4)Belmin J, Meaume S, Rabus MT, et al : Sequential CQ 2. 14:Which dressings are recommended if treatment with calcium alginate dressings and undermining is found? hydrocolloid dressings accelerates pressure ulcer [ Recommendation ]If necrotic tissue is present healing in older subjects : A multicenter randomized within the undermining, first remove this through trial of sequential versus nonsequential treatment lavation. If the amount of exudate is excessive, with hydrocolloid dressings alone. J Am Geriatr Soc, consider using alginate, silver-containing Hydrofiber®, 50(2):269-274, 2002.(LevelⅡ) or alginate silver. 5)Ausili E, Paolucci V, Triarico S, et al : Treatment of [Rating]C1 pressure sores in spina bifida patients with calcium [ Analysis ]One case report claimed favorable alginate and foam dressings. Eur Rev Med Pharmacol results for the use of alginate inside the undermining, Sci, 17(12):1642-1647, 2013.(LevelⅤ) after granulation formation and reduction in the size 6)Heyneman A, Beele H, Vanderwee K, et al : A of the undermining were achieved(Evidence Level systematic review of the use of hydrocolloids in the Ⅴ)1). treatment of pressure ulcers. J Clin Nurs, 17(9): No studies have been published on the efficacyof 1164-1173, 2008.(LevelⅠ) silver-containing Hydrofiber® and silver alginate when applied to undermining, and the method is CQ 2.13:Which dressings are recommended when endorsed onlybyexpert opinion(Evidence LevelⅥ). necrotic tissue is present? When using these dressings inside the wound pocket, [ Recommendation ]If surgical debridement or care must be taken not to force the dressing too topical agents capable of removing necrotic tissue are deeplyinto the cavityor cause undue pressure on the unavailable, hydrogel may be considered. surrounding tissue surfaces. If necrotic tissue re- [Rating]C1 mains, prioritize debridement. [ Analysis ]One randomized controlled trial1) ex- References amined the use of hydrogel and dextranomer paste in connection with the removal of necrotic tissue and 1)Tsukada K : Usefulness of sponge-type alginate gel reported no significant difference in the rate of dressing on tissue granulation of pressure ulcers . Jpn removal of necrotic tissue for either type of dressing. JPU, 5(1):27-32, 2003.(Japanese, English abstract) The recommendation level assigned to these dres- sings is therefore C1. In addition to these studies, CQ 2.15:Is the so-calledkwrap dressingl*effec- Parnell et al. have published a case report in which tive in treating pressure ulcers? hydrogel with endopeptidase was used to treat stage [Recommendation]Wrap dressings can be consi- Ⅱ and Ⅲ pressure ulcers assessed clinicallyas in- dered for use whenever medicallyapproved dressings fected and requiring removal of necrotic tissue2). The are unavailable or difficult to obtain on a continual stageⅡ and Ⅲ pressure ulcers which had not been basis, such as in a home based medical care. However, treated for three months prior to commencement of use of the wrap dressing should be supervised bya the studyhealed in an average of 3.3 weeks and 6.5 physician with an adequate knowledge of pressure weeks, respectively, but the effect of hydrogel could ulcer care and onlyafter the patients and their family not be assessed because it was used in combination have been instructed in the procedure and given their with other dressings. consent. kWrap* dressinglis a dressing technique of References covering wounds with non-medicallyapproved(un- 1)Colin D, Kurring PA, Yvon C : Managing sloughy sterilized)and non-adhesive commerciallyavailable

―G−38― 褥瘡会誌(2016) ― 493 ― plastic wrap. References [Rating]C1 [ Analysis ]A comprehensive survey of evidence 1)Takahashi J, Yokota O, Fujisawa Y, et al : An pertaining to thekwraplmethod of dressing wounds evaluation of polyvinylidene film dressing for treat- showed that while there is an abundance of case ment of pressure ulcers in older people. J Wound reports and comments byspecialists, there is onlyone Care, 15(10):449-454, 2006.(LevelⅢ) randomized clinical trial, and two non-randomized 2)Mizuhara A, Bito S, Onishi S, et al : The therapeutic clinical trials systematically comparing this dressing effectiveness of wrap therapy: A studycomparing to standard dressings. wrap therapyto standard therapyper current A non-randomized controlled trial involving sub- guidelines. Jpn JPU, 13( 2 ):134-141, 2011.( Level jects with classⅢ-Ⅳ class pressure ulcers(according Ⅱ)(Japanese, English abstract) to the NPUAP guidelines ), found a significantly 3)Ueda T, Shimokubo S, Honda K, et al : The evaluation greater reduction in wound size after 12 weeks of food-wrap treatment for pressure ulcers. Jpn JPU, following the use of wrap dressings in comparison to 8(4):551-559, 2006.(LevelⅢ)(Japanese, English the control dressings, as indicated bythe DESIGN abstract) scores(p=0.011). The cure rate and the exacerba- 4)Moriyama Y : Severe complication associated with tion rate were the same1). Furthermore, a randomized inadequate wet dressing therapy: benefits and risks clinical trial conducted jointlyinvolving NPUAP class of so-calledT wrap therapyU. Jpn J Dermatol, 120 Ⅱ-Ⅲ adult pressure ulcer patients found no significant (11):2187-2194, 2010.(LevelⅤ)(Japanese, English difference in effect between wrap dressings and the abstract) comparison group across three parameters, the 5)Moriyama Y, Hirakawa K, Ota M : Proposals regard- DESIGN-R score, the PUSH score, and changes in ing wet dressing therapyeducation based on cases of wound size. However, the cost of wrap dressings was wrap therapyencountered at our hospital. Jpn JPU, appreciablylower than that of other typesof 14(4):598-604, 2012.(LevelⅤ) dressing2). Further, in a non-randomized controlled trial involving adult patients3), no difference was CQ 3 Surgical Intervention recorded in midpoint of treatment period for wrap In cases requiring surgical intervention for the dressings and conventional dressings( p=0. 92 ). treatment of pressure ulcers, the use of anesthetics, However, the dailycost of wrap dressings was postoperative positioning, and other perioperative significantlylower 3). In all three of these clinical trials matters must be managed with care. The timing and there was no difference between wrap and other extent of the surgerywill largelybe determined by types of dressing in terms of worsening symptoms or the general state of the patientls physical health as deleterious effects. However, two case reports4, 5) well as the condition of the specific area targeted for claimed that there were two cases in which symptoms intervention. worsened as a result of the use of wrap dressings. As indicated in theTAlgorithm on the prevention On the basis of the reports discussed above, and in and management of pressure ulcersU(Fig. 1), surgical accordance with the official position of the 2010 Board intervention is seen as one option for local treatment of the Japan Societyof Pressure Ulcers, the use of of pressure ulcers. officiallyapproved dressings is recommended for the Importantly,k Pressure ulcer present lin the treatment of pressure ulcers. As a non-medically TAlgorithm on surgical interventionU(Fig. 3)is to approved item, the wrap dressing maybe considered be understood as referring to patients who have for use in home based medical care and other settings alreadyreceived systemiccare and predictive assess- in which the continued use of approved dressings ment, but whose existing pressure ulcers have proved maybe difficult. However, its use should be supervised resistant to conservative forms of treatment, such as bya physicianwith an adequate knowledge of external medication and dressing. pressure ulcer care and onlyafter the patients and Determining the optimal area of the pressure ulcer their familyhave been instructed in the procedure to be treated with surgical intervention and deciding and given their consent. the best timing for the procedure are often difficult.

―G−39― ― 494 ―

Fig. 3 Algorithm illustrating options for surgical interventions

For this reason, we have decided to discuss the conducted if there is evidence of pus, foul odor, or indications for reconstructive surgeryseparately osteomyelitis accompanying the infection. from anydiscussion of the condition of the pressure [Rating]C1 ulcer as a local factor more pertinent to the question of [Analysis]Surgical debridement should be consi- whether or not surgical debridement should be dered for infected pressure ulcers that resist systemic employed. Surgical treatment of undermining is also administration of antibiotics or topical application of addressed in a separate CQ as a factor resistant to external antibiotic preparations and dressings. Local conservative treatment. abscesses and retention fluid should be lanced and Further, given the fact that even deep ulcers(D3) drained to prevent expansion into surrounding intact do not always require reconstructive surgery but may tissue and/or progression to systemic sepsis. be treated successfullywith conservative treatments The presence of hardened and thickened necrotic that promote granulation tissue formation to achieve tissue( eschar )accompanied byfever, local in- wound closure, the general topic of surgical treatment flammation( redness, swelling, and pain ), and foul has been divided into surgical debridement and odor maypoint to an underlyingpus-filled abscess. reconstructive surgeryfor more separate discussion. For this reason an incision into a portion of the In addition, the use of negative pressure wound necrotic tissue is recommended to confirm the therapy(NPWT)to treat wounds resulting from the presence of pus1). Especiallyin cases in which the removal of necrotic tissue following surgical debride- nidus of infection in the necrotic tissue has caused ment is considered in CQ in this section. sepsis, it is stronglyrecommended that first, the abscess be incised and the sinus and fistula be drained CQ 3. 1:Is surgical debridement indicated when as soon as possible, and second, that the necrotic signs of infection/inflammation of the pressure ulcer tissue be removed completelyif the patientls condi- are present? tion allows. [Recommendation]Surgical debridement maybe Indeed the efficacyof surgical debridement in

―G−40― 褥瘡会誌(2016) ― 495 ― controlling infections associated with pressure ulcers resection on infection-free survival. J Bone Joint Surg has been corroborated bythe findings of a controlled Br, 83(3):403-407, 2001.(Evidence level : Ⅳ) study2). Furthermore, two guidelines issued by NPUAP/EPUAP3) and WOCN4) assign theTStrength CQ 3.2:What is the optimal timing for the surgical of EvidenceUrating of C to surgical debridement in debridement of necrotic tissue in pressure ulcers? the presence of advancing cellulitis, crepitus, fluc- [Recommendation] tuance, and/or sepsis secondaryto ulcer-related 1.Surgical debridement maybe considered when infection. Also, in suspected patients with necrotizing a clear line of demarcation between necrotic and fasciitis, bacteriological evaluation with examination healthytissue is visible. of the LaboratoryRisk Indicator for Necrotizing [Rating]C1 Fasciitis(LRINEC)score and the administration of [Recommendation] antibiotics appropriate for the causative microorgan- 2.Surgical debridement is considered when pre- isms and debridement bring about high therapeutic existing infection has been brought under control. efficacy5). The remaining sources dealing with surgic- [Rating]B al interventions for the treatment of infection are [Analysis]In cases in which infection has resulted general, textbook descriptions with limited utility. in tissue necrosis, anyattempt to remove the necrotic There are at present no high-level studies dealing tissue too rapidlymayresult in severe pain and with the efficacyof surgical treatment of osteomyelitis bleeding in the wound margins. Surgical debridement accompanying pressure ulcers. However, a cohort is recommended after the acute phase( about 3 studycomprising 50 cases of osteomyelitisunrelated weeks)when the demarcation line between necrotic to pressure ulcers has reported a lowered recurrence tissue and the surrounding intact tissue has become rate following wide resectioning of degraded bone clear1,2). tissue6). Necrotic tissue which is allowed to remain within the wound bed or on the edges of the pressure ulcers References mayevolve into a nidus of infection and impede the 1)Bergstrom N, Bemet M, Carlson C, et al : Pressure wound healing process. For this reason, the WOCN ulcer treatment. Clinical practice guideline : Quick and AHCPR guidelines recommend external medica- reference guide for clinicians. No.15. Rockville, MD : U. tions, dressings, enzyme preparations, and surgical as S. Department of Health and Human Services. Public well as biological debridement as treatment options1, 2). Health Service, Agencyfor Health Care Policyand References Research. AHCPR Pub, No.95-0653, 1994. 2)Galpin JE, Chow AW, Bayer AS, et al : Sepsis 1)Ratliff CR, Tomaselli N : WOCN update on evidence- associated with decubitus ulcers. Am J Med, 61(3): based guideline for pressure ulcers. J Wound Ostomy 346-350, 1986.(Evidence level : Ⅳ) Continence Nurs, 37( 5 ):459-460, 2010.[ Update of 3)National Pressure Ulcer AdvisoryPanel and Euro- Wound Ostomyand Continence Nurse Society: pean Pressure Ulcer AdvisoryPanel : Surgeryfor Guideline for Prevention and Management of Press- Pressure Ulcers. Prevention and treatment of press- ure Ulcers. Adv Skin Wound Care, 18(4):204-208, ure ulcers : clinical practice guideline, 96-99, National 2005] Pressure Ulcer AdvisoryPanel, Washington DC, 2)Bergstorm N, Allman RM, Alvarez MA, et al : 2009. Treatment of Pressure Ulcers Clinical Practice 4)Ratliff CR, Tomaselli N : WOCN update on evidence- Guidelines number 15, No95-0652, US Department of based guideline for pressure ulcers. J Wound Ostomy Health and Human Services. Public Health Service, Continence Nurs, 37(5):459-460, 2010. Agencyfor Health Care Policyand research. AHCPR 5)Mizokami F, Furuta K, Isogai Z : Necrotizing soft Publication, Rockville Maryland, 1994.(LevelⅣ) tissue infections developing from pressure ulcers. J Tissue Viability, 23(1):1-6, 2014.(LevelⅣ) CQ 3.3:Is surgical incision or debridement recom- 6)Simpson AH, Deakin M, Latham JM : Chronic mended if undermining is present? osteomyelitis. The effect of the extent of surgical [ Recommendation ]Surgical incision or debride-

―G−41― ― 496 ― ment is recommended for treating undermining prospective cohort studyof pressure ulcers bythe which fails to respond to more conservative treat- Japanese national hospital organization. Wound ments. Repair Regen, 21(4):512-519, 2013.(LevelⅣ) [Rating]B 4)Kosaka M, Morotomi T, Suzuki H : Selection of [Analysis]The presence of undermining raises the perforator flaps for sacral pressure ulcers with a possibilityof necrotic tissue underlyingthe formation. subdermal pocket. Jpn JPU, 4( 3 ):371-378, 2002. In such cases, surgical intervention to lance and drain, (Level Ⅴ)(Japanese, English abstract) or debride, the abscess, sinus tract, or bursa should be 5)Seike T, Hashimoto I, Nakanishi H, et al : Two cases of considered if no improvement results from more pressure ulcers healed using undermining skin as a conservative treatments such as wound cleansing, or bipedicle flap. Jpn JPU,15(2):135-143, 2013.(Level application of topical agents. However, a thorough Ⅳ) systemic assessment should be made, including an assessment of the patientls propensityto bleed, before CQ 3.4:When is surgical debridement indicated? the undermining is incised with the aid of the [Recommendation] appropriate tools to stop bleeding1). In cases of 1.Conservative treatments are the preferred pressure ulcers of long duration or with an excep- option, but surgical debridement maybe performed tionallylarge cavity(DESIGNscore of P3 or higher), when infection/inflammatorysigns are under control. surgical incision of the undermining should be [Rating]C1 considered2). Since a cohort studyreported an 2.Surgical debridement maybe considered for improvement in the total score of DESIGN-R with a patients with a D3 or D4 pressure ulcer. significant difference in the categoryof G, pocket [Rating]C1 incision is considered useful3). On the other hand, 3.Surgical debridement maybe considered Kosaka et al.4)argue that a preoperative incision to the according to the location of the infected pressure skin overlying the undermining may lead to scar ulcer, the volume and extent of the necrotic tissue, the contracture and hamper reconstructive flap surgery; blood supplyto the surrounding tissue, condition of hence the undermining should be allowed to remain if the wound margin, and the patientls level of pain there is no infection. There is also a report that a tolerance. surgical procedure in which pocket incision and [Rating]C1 drainage are performed while the skin over the [Analysis]Surgical debridement is generally indi- pocket is conserved was beneficial for wound cated when the pressure ulcer infection has been healing5). However, in cases in which surgical in- brought under control and the necrotic tissue or tervention is ruled out, incision of the pocket is still degraded granulation tissue fails to respond to preferable to onlycontinuing more conservative conservative treatments. The NPUAP/EPUA and forms of treatment. WOCN guidelines recommendT maintenance de- The present change in the recommendation level bridementUfor the acute phase1, 2). was determined because of the presence of extremely This form of treatment is indicated for wound stage high-qualityliterature with an evidence level of Ⅳ. D3 or deeper. Due to the long recoveryperiod required when the pressure ulcer has invaded muscle References tissue and penetrated to the bone( D4 ), surgical 1)WhitneyJ, Phillips L, Aslam R, et al : Guidelines for debridement is recommended in order to expedite the treatment of pressure ulcers. Wound Repair recovery3). If the wound margin is deteriorated, the Regen, 14(6):663-679, 2006. wound environment can be improved byrefreshing 2)Nakamura M, Ito M : Slide-swing Plastyfor the Repair the wound margin bydebridement 4). of Pressure Ulcers Ⅰ: Operation Techniques. Jpn As indicated above, surgical debridement can prove JPU, 2(3):236-243, 2000.(LevelⅥ)(Japanese, either too invasive or insufficient. This fact needs to be English abstract) considered pre-operativelywhen evaluating the 3)Nagase T, Iizaka S, Kato H et al : Undermining balance of risk and benefit of the procedure to the incision and healing of deep pressure ulcers : a patient1, 2, 5, 6).

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[Rating]C1 References [Analysis]Two cohort studies1, 2)of direct suturing 1)Ratliff CR, Tomaselli N : WOCN update on evidence- and skin grafts support performing wound closure based guideline for pressure ulcers. J Wound Ostomy under infection-free conditions. Although these stu- Continence Nurs, 37(5):459-460, 2010.[Update of dies deal with general wounds and not pressure ulcers Wound Ostomyand Continence Nurse Society: in particular, the findings are worth listing for their Guideline for Prevention and Management of Press- value in assessing surgical indication. ure Ulcers. Adv Skin Wound Care, 18(4):204-208, Surgical reconstructive surgeryis recommended 2005] for D3 or D4 pressure ulcers, which penetrate beyond 2)National Pressure Ulcer AdvisoryPanel and Euro- subcutaneous tissue3). When the wound depth extends pean Pressure Ulcer AdvisoryPanel : Debridement. beyond the subcutaneous tissue in areas normally In : DealeyC, Cuddigan J, eds. Prevention and favoring pressure ulcer formation, tissue characteris- treatment of pressure ulcers : clinical practice guide- ticallyhaving low blood supplysuch as the bone line, 77-80, National Pressure Ulcer AdvisoryPanel, cortex, ligaments, joints and tendons capsules, are Washington DC, 2009. often exposed in the wound bed. When pressure 3)Motegi S : Consideration for Better Treatment of ulcers fail to close after conservative treatment, Pressure Ulcers Based on MyExperience. Jpn JPU, 2 surgical intervention to repair the wound should be (1):57-64, 2000.(LevelⅤ)(Japanese, English ab- considered rather than continue a less effective stract) regimen4). 4)Agosti JK, Chandler LA, Anderton CM et al : Serial An advancing wound edge fibrosis and scar sharp debridement and formulated collagen gel to formation surrounding the pressure ulcer are signs of treat pressure ulcers in elderlylong-term care delayed wound healing5). Debridement of such fibro- patients : a case study. Ostomy Wound Manage, 59 tic/scar tissue typically creates a wound penetrating (11):43-49, 2013.(LevelⅤ) beyond the subcutaneous tissue. In such cases, 5)Kurita M, Oshima Y, Ichioka S, et al : Effects of reconstructive surgeryshould be seriouslyconsi- invasive treatments in pressure ulcer patients on the dered, as mentioned above. general condition(analysis using the POSSUM). Jpn Surgical removal or sequestrectomyoften leaves a JPU, 7(2):178-183, 2005.(LevelⅣ) skin defect extending beyond the subcutaneous 6)Kurita M, Ichioka S, Oshima Y, et al : Orthopaedic tissue. The need for surgical repair should seriously POSSUM scoring system : An assessment of the risk be considered in such cases6). of debridement in patients with pressure sores. Scand References J Plast Reconstr Surg Hand Surg, 40(4):214-218, 2006.(LevelⅣ) 1)Kizek TJ, Robson MD, Kho E : Bacterial growth and skin graft survival. Surg Forum, 18 : 518-519, 1967. CQ 3.5:When is reconstructive surgeryindicated? (LevelⅠ) [Recommendation] 2)Robson MC, Lea CE, Dalton JB, et al : Quantitative 1.Reconstructive surgerymaybe considered for bacteriologyand delayedwound closure. Surg Forum, D3−D4 pressure ulcers that do not respond to 19 : 501-502, 1968.(LevelⅠ) conservative treatments. 3)Disa JJ, Carlton JM, Goldberg NH : Efficacyof [Rating]C1 operative cure in pressure sore patients. Plast 2.Surgical reconstruction maybe considered for Reconstr Surg, 89(2):272-278, 1992.(LevelⅣ) ulcers showing a non-advancing edge and scar 4)Motegi S : Consideration for Better Treatment of formation. Pressure Ulcers Based on MyExperience. Jpn JPU, 2 [Rating]C1 (1):57-64, 2000.(LevelⅤ)(Japanese, English ab- 3.Reconstructive flap surgeryfollowing seques- stract) tration maybe considered as a therapeutic option for 5)Ichioka S, Ohura N, Nakatsuka T : Benefits of surgical osteomyelitis in pressure ulcers. reconstruction in pressure ulcers with a non- advancing edge and scar formation. J Wound Care, 14

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(7):301-305, 2005.(LevelⅤ) Surg, 41(12):1113-1119. 1998.(LevelⅣ)(Japanese, 6)WhitneyJ, Phillips L, Asla m R : Guidelines for the English abstract) treatment of pressure ulcers. Wound Repair Regen, 2)Foster RD, AnthonyJP, Mathes SJ, et al : Flap 14(6):663-679, 2006. selection as a determinant of success in pressure sore coverage. Arch Surg, 132(8):868-873, 1997.(Level CQ 3.6:Which reconstructive surgical procedure is Ⅴ) considered especiallyeffective for pressure ulcers? 3)Larson DL, Machol JA 4th, King DM : Vastus lateralis [ Recommendation ]There are numerous options flap reconstruction after Girdlestone arthroplasty: for reconstructive surgeryfor pressure ulcers, but thirteen consecutive and outcomes. Ann Plast Surg, insufficient evidence on the outcome of anyof these 71(4):398-401,2013.(LevelⅤ) procedures. For this reason, no single surgical 4)Nojima K : The surgical Treatment of Pressure procedure can be recommended as applicable to all Ulcers : Analysis of 92 cases. Tokyo Jikei-kai Ika cases. Daigaku Zasshi, 119( 6 ):441-453, 2004.( LevelⅤ ) [Rating]C1 (Japanese, English abstract) [Analysis]Surgical reconstruction is indicated for 5)Kuwahara M, Tada H, Mashiba K, et al : Mortalityand pressure ulcers in which complications have been recurrence rate after pressure ulcer operation for brought under control, and wound infection and elderlylong-term bedridden patients. Ann Plast Surg, necrotic tissue have been removed bysystemic, 54(6):629-632, 2005.(LevelⅤ) conservative, physiotherapeutic, or surgical treat- 6)Wong TC, Ip FK : Comparison of gluteal fasciocu- ment. If the decision is made to perform surgical taneous rotational flaps and myocutaneous flaps for debridement and reconstructive surgerysimul- the treatment of sacral sores. Int Orthop, 30(1):64- taneously, any tissues involved in the pressure ulcer 67, 2006.(LevelⅤ) such as skin, granulation tissue, necrotic tissue, 7)Sameem M, Au M, Wood T, et al:Asystematic subdermal sinuses, abscesses, bursae, and bone must review of complication and recurrence rates of first be removed surgically1). According to one study, musuculocutaneous, fasciocutaneous, and perforator there is no significant difference in the cure rate based flaps for treatment of pressure sores. Plast between simultaneous and two-stage surgery2). Sur- Reconstr Surg, 130(1):67e-77e, 2012.(LevelⅠ) gical treatments for septic arthritis of the hip as a complication have also been reported3). CQ 3. 7:What kind of physiotherapy is recom- Within the past several years, three retrospective mended for pressure ulcers with low amounts of case controlled studies have been published compar- granulation tissue? ing the recurrence rate among patients who under- [ Recommendation ]Negative pressure wound went surgical procedures4−6). However, due to the therapy(NPWT)may be considered for the treat- small number of cases in each study, and the lack of ment of wounds following debridement of infectious or standardization or uniformityin perioperative man- necrotic tissue. agement and care, the cure and recurrence rates [Rating]C1 claimed bythese reports cannot be assessed with any [ Analysis ]Negative pressure wound therapy accuracy. Yet, a systematic review7) infers that (NPWT)is designed to control the wound healing reconstruction methods are selected according to process under negative pressure conditions by various factors of treatment contents rather than covering the whole wound surface with an airtight complications or the recurrence rate, and the estab- dressing. lishment of a standard perioperative management The various kinds of NPWT equipment featured in procedure is awaited for the future. review articles and guidelines are commercially available. When using anyof these products, the References wound surface should first be sealed air-tight using 1)Yamamoto Y, Koyama A, Tsutsumida S, et al : the sponge speciallyprovided for this purpose. A Reconstructive Surgerywith the Fasciocutaneous pressure of -125mmHG is typically recommended1−3). Flap for the Treatment of Pressure Sores. Jpn J Plast The WOCN4) and NPUAP/EPUAP guidelines5)

―G−44― 褥瘡会誌(2016) ― 499 ― assign NPWT an evidence level of(B)for its efficacy Pressure Ulcer AdvisoryPanel, Washington DC, in rapidlyreducing wound depth, and improving the 2009. healing rate and granulation tissue formation6). 6)Srivastava RN, Dwivedi MK, Bhagat AK, et al : A non- Further, two meta-analytical studies1, 3) rated NPWT randomized controlled clinical trial of an innovative more highlythan conventional treatments for its device for negative pressure wound therapyof efficacyagainst chronic skin ulcers, such as diabetic, pressure ulcers in traumatic paraplegia patients. Int stasis, and pressure ulcers, and trauma. However, Wound J, 2014 Jun 3 ; doi:10.1111/iwj.120309.(Level randomized controlled trials reported no significant Ⅲ) difference7) and a significant reduction in the wound 7)Gregor S, Maegele M, Saucherland S, et al : Negative size8) compared with conventional treatments for Pressure Wound TherapyA Vacuum of Evidence?. wounds such as wet-to-drydressing and external Arch Surg, 143(2):189-196, 2008.(LevelⅠ) medications. Although a report of a randomized 8)de Laat EH, van den Boogaard MH, Spauwen PH, et controlled trial concerning pressure ulcers of the heel al : Faster wound healing with topical negative was added8), it was not sufficient to elevate the pressure therapyin difficult-to-heal wounds ; a recommendation level, because the number of pa- prospective randomized controlled trial. Ann Plast tients was small, and the treatment of the control Surg, 67(6): 626-631, 2011.(LevelⅡ) group differed from treatment performed in Japan. 9)Sano H, Ichioka S, Tajima S : Topical oxygen therapy NPWT is an option for treating pressure ulcers for sacral pressure ulcer. Jpn JPU,14(4):605-609, when infection/necrosis is controlled. However, there 2012.(LevelⅤ) are no grounds for prioritizing it over other treat- ments. CQ 4 General management There is also a case report that granulation was CQ 4.1:Which underlying medical conditions may promoted in refractorypressure ulcer bytopical entail the risk of leading to pressure ulcers? oxygen therapy following surgical debridement9). [Recommendation] 1.Conditions including congestive heart failure, References pelvic fracture, spinal cord injury, diabetes, cerebro- 1)Ubbink DT, Westerbos SJ, Evans D, et al : Topical vascular disease, and chronic obstructive pulmonary negative pressure for treating chronic wounds. disease maybe considered. Cochrane Database Syst Rev 2008, Issue 3. Art. No. : [Rating]C1 CD001898. DOI : 10. 1002/14651858. CD001898. pub2. 2.In the perioperative management, it is recom- (LevelⅠ) mended to consider diabetes in particular. 2)Wanner MB, Schwarzl F, Strub B, et al : Vacuum- [Rating]B assisted wound closure for cheaper and more [Analysis]The following is evidence pertaining to comfortable healing of pressure sores : a prospective co-morbidityrisk factors for pressure ulcer develop- study. Scand J Plast Reconstr Surg Hand Surg, 37 ment. Regarding analytical epidemiological studies, (1):28-33, 2003.(LevelⅡ) those with 1,000 or more subjects were adopted. 3)Ford CN, Reinhard ER, Yeh D, et al : Interim analysis There are four analytical epidemiological studies of a prospective, randomized trial of vacuum-assisted that evaluated the relationship between underlying closure versus the health point system in the medical conditions and the occurrence of pressure management of pressure ulcers. Ann Plast Surg, 49 ulcer in non-perioperative clinical conditions. Of the (1):55-61, 2002.(LevelⅡ) two cohort studies in nursing home residents, the one 4)Ratliff CR, Tomaselli N : WOCN update on evidence- with 36,649 subjects1) showed that the occurrence of based guideline for pressure ulcers. J Wound Ostomy pressure ulcer was significantlyrelated to pelvic Continence Nurs, 37(5):459-460, 2010. fracture, diabetes, and peripheral vascular disorders, 5)National Pressure Ulcer AdvisoryPanel and Euro- and the one with 4,232 subjects2) showed that it was pean Pressure Ulcer AdvisoryPanel : Surgeryfor significantlyrelated to diabetes alone. A cohort study Pressure Ulcers. Prevention and treatment of press- in 75, 158 outpatients3) showed significant relations ure ulcers : clinical practice guideline, 96-99, National with malignant neoplasm, Alzheimerls disease, con-

―G−45― ― 500 ― gestive heart failure, rheumatoid arthritis, osteopor- Also, there is one meta-analysis that evaluated the osis, deep vein thrombosis, diabetes, urinarytract relationship between diabetes and the perioperative infection, cerebrovascular disease, Parkinsonls dis- occurrence of pressure ulcer6) and reported that the ease, and chronic obstructive lung disease. In a case- risk of perioperative pressure ulcer was significantly control studyin 51,842 hospital inpatients 4), significant higher in diabetic patients. Since onlycohort studies relationships with congestive heart failure, diabetes, and case-control studies were reviewed, the recom- cerebrovascular disease, and chronic obstructive lung mendation level was rated as B. disease were observed. Also, in the guidelines bythe References American Professional Wound Care Association5) spinal cord injuryis mentioned as a risk factor for 1)Berlowitz DR, Brandeis GH, Anderson JJ, et al : pressure ulcer. While these underlying conditions Deriving a risk-adjustment model for pressure ulcer maybe regarded as risk factors for pressure ulcer, development using the Minimum Data Set. J Am theyare also reported to be unrelated. In the present Geriatr Soc, 49(7):996-997, 2001.(LevelⅣ) guidelines, therefore, congestive heart failure, pelvic 2)Brandeis GH, Ooi WL, Hossain M, et al : A longitudinal fracture, diabetes, cerebrovascular disease, and chro- studyof risk factors associated with the formation of nic obstructive lung disease, which were significantly pressure ulcers in nursing homes. J Am Geriatr Soc, related to pressure ulcer in multiple studies, and 42(4):388-393, 2004.(LevelⅣ) spinal cord injury, which was mentioned in other 3)Margolis DJ, Knauss J, Bilker W, et al : Medical guidelines, are listed as diseases that need particular conditions as risk factors for pressure ulcers in an attention in Recommendation 1. outpatient setting. Age Ageing, 32(3):259-264, 2003. (LevelⅣ) 4)Lyder CH, Wang Y, Metersky M, et al : Hospital- acquired pressure ulcers : results from the national Medicare patient monitoring system study. J Am Geriatr Soc, 60(9):1603-1608, 2012.(LevelⅣ) 5)Stechmiller JK, Cowan L, WhitneyJD, et al : Guidelines for the prevention of pressure ulcers. Wound Repair Regen, 16(2):151-168, 2008. 6)Liu P, He W, Chen HL : Diabetes mellitus as a risk factors for surgery-related pressure ulcers : a meta- analysis. J Wound Ostomy Continence Nurs, 39(5): 495-499, 2012.(LevelⅠ) Fig. 4 Algorithm illustrating options for general manage- ment of pressure ulcer prevention

Fig. 5 Algorithm illustrating general management after occurrence of pressure ulcer

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CQ 4. 2:What form of nutritional intervention is References recommended for the prevention of pressure ulcers in malnourished patients? 1)Langer G, Fink A : Nutritional interventions for [ Recommendation ]For patients suffering from preventing and treating pressure ulcers. Cochrane protein-energymalnutrition( PEM ) , using a en- Database Syst Rev,(6):CD003216, 2014.(LevelⅠ) hanced energyand protein supplement after due 2)Stratton RJ, Ek AC, Engfer M, et al : Enteral consideration of anyunderlyingconditions is recom- nutritional support in prevention and treatment of mended. pressure ulcers:Asystematic review and meta- [Rating]B analysis. Ageing Res Rev, 4( 3 ):422-450, 2005. [ Analysis ]A high-calorie, high-protein dietary (LevelⅠ) supplement was found to be effective in promoting 3)Bourdel-MarchassonⅠ, Barateau M, RondeauⅤ, et al : healing of pressure ulcers among PEM( protein- A multi-center trial of the effects of oral nutritional energymalnutrition )patients who are unable to supplementation in criticallyill older inpatients. obtain the requisite quantities of these nutrients from GAGE Group. Groupe Aquitain Geriatrique their regular meals1, 2). dlEvaluation. Nutrition, 16(1):1-5, 2000.(LevelⅡ) In the Cochrane Database Systematic Review1),a 4)Hartgrink HH, Wille J, König P, et al : Pressure sores meta-analysis of 8 studies of nutritional supplements and tube feeding in patients with a fracture of the hip : and hospital diet for the prevention of pressure ulcer A randomized clinical trial. Clin Nutr, 17(6):287- was carried out. In one study, pressure ulcer occurred 292, 1998.(LevelⅡ) less frequentlyin the group of elderlypatients in the 5)Houwing RH, Rozendaal M, Wouters-Wesseling W, et acute phase given 200 kcal/dayof nutritional supple- al : A randomised, double-blind assessment of the ment for 15 days( 295 patients, 40. 6% )compared effect of nutritional supplementation on the preven- with the control group( 377 patients, 47. 2% )3).In tion of pressure ulcers in hip-fracture patients. Clin patients with femoral neck fracture at a high risk of Nutr, 22(4):401-405, 2003.(LevelⅡ) pressure ulcer, the serum total protein and albumin 6)Delmi M, Rapin CH, Bengoa JM, et al : Dietary levels were significantlyhigher in the group that supplementation in elderlypatients with fractured received nutritional support4), and the incidence of neck of the femur. Lancet, 335( 8696 ):1013-1016, stageⅡ pressure ulcer was lower, and the time until 1990.(LevelⅡ) onset was longer, when the patients were given 7)Ek AC, Unosson M, Larsson J, et al : The development supplementaryfood with high protein, arginine, zinc, and healing of pressure sores related to the nutrition- and antioxidant contents5). When patients with al state. Clin Nutr, 10(5):245-250, 1991.(LevelⅣ) femoral neck fracture were managed with nutritional 8)Little MO : Nutrition and skin ulcers. Cur Opin Clin support, the clinical outcome was favorable, and the Nutr Metab Care, 16(1):39-49, 2013.(LevelⅠ) incidence of complications was significantlylower 6).In addition, dietaryintake has been reported to be a CQ 4. 3:How should patients incapable of oral predictive index of pressure ulcer7). A systematic intake of nutrition and hydration be fed? review8) showed that the resting energyexpenditure [Recommendation]Required nutrition is supplied ( REE )is significantlyhigher in bedridden elderly byenteral tube-feeding, but, if it is impossible, women with stageⅢ or Ⅳ pressure ulcer than in parenteral feeding maybe employed. those with no pressure ulcer and indicated the [Rating]C1 necessityof the assessment of the nutritional require- [ Analysis ]If oral nutrition intake is impossible, ment and intake and appropriate nutritional support. enteral tube-feeding or parenteral feeding is selected. On the basis of the evidence level of these studies, However, there has been no studythat comparatively nutritional intervention is assigned the recommenda- evaluated the superiorityof the feeding route from tion rating of B with the proviso that the underlying the viewpoint of treatment/prevention of pressure condition of the patient, if any, be duly considered. ulcer. While the NPUAP/EPUAP quick reference guide1)shows the necessityof enteral tube-feeding or parenteral feeding if oral nutrition intake is inadequ-

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ate or impossible, it does not discuss the superiorityof assess risk. feeding routes. Therefore, as a general rule for the In analytical epidemiological studies of pressure selection of the feeding route,T Use enteral tube- ulcer risk, total protein, serum albumin, and pre- feeding as much as possible, and use parenteral albumin values are examined to determine risk. feeding when oral nutrition intake is impossible or Among these, the serum albumin or prealbumin level insufficient Ustated as expert opinion or in the is a commonlyused index of pressure ulcer risk. Low guidelines of the Japanese Societyfor Parenteral & serum albumin values indicate high risk for pressure Enteral Nutrition2) was adopted. On the basis of the ulcers1−7). Values below 3.5 g/dl indicate a particularly evidence level, and recommendation level was rated high risk3−6). Moreover, according to a systematic as C1. The manner in which the patient is fed should review of RCTs and analytical epidemiological studies, be decided after due consideration of the prognosis, 7(63.6%)of 11 studies reported that albumin is a goals of treatment, and individual differences. risk factor for pressure ulcer8). However, as rebuttal evidence, the albumin level has been reported not to References be significantlycorrelated with the total-bodyand 1)European Pressure Ulcer AdvisoryPanel and Nation- limb muscle mass or lean bodymass 9) and to be al Pressure Ulcer AdvisoryPanel : Prevention and negativelycorrelated( p<0.01)with C-reactive pro- treatment of pressure ulcers : quick reference guide. tein( CRP ), which is a marker of inflammatory National Pressure Ulcer AdvisoryPanel, Washington reaction, in pressure ulcer patients10). Thus, while DC, 2009. albumin cannot be recommended as an index of 2)Japanese Societyfor Parenteral and Enteral Nutri- malnutrition, it is an important risk factor for pressure tion : Practical guidelines for parenteral and enteral ulcer, and as the evaluation of albumin is significant, nutrition 3rd Ed, Shorinsha, Tokyo, 2013.(Japanese) its recommendation level was rated as C1. However, as albumin shows false values depending on inflamma- CQ 4. 4:What indices can be used to assess the tion and dehydration, it must be added that it is valid level of malnutrition as a risk factor for pressure without inflammation or dehydration. ulcers? The bodyweight is a simple index of the nutritional [Recommendation] state, and a bodyweight loss is considered to be a risk 1.In the absence of inflammation or dehydration, factor for pressure ulcer. Among newlypatients at the serum albumin levels maybe used. StageⅢ or Ⅳ pressure ulcers, a decrease in % usual [Rating]C1 bodyweight( UBW )is reportedlycorrelated to 2.Rate of weight loss maybe considered for use. increased pressure ulcer risk11). Haydock and Hill [Rating]C1 report that moderatelyto severelyundernourished 3.Consider using the rate( amount )of food surgical patients showed a decrease in bodyweight of intake as an index. 9.6% and 19.6%, respectively, and wound healing was [Rating]C1 impaired more than in patients assessed to be in 4.Mini Nutritional Assessment(MNA)or MNA®- k good lcondition( p<0. 001 )12). In a cohort study Short Form(SF)maybe used with elderlypatients. examining the risk for pressure ulcers at StageⅡ or [Rating]C1 higher among in-patients who were either bed-ridden 5.CONUT( controlling nutritional status )may or confined to a sitting position, a decrease in body be used. weight was reported to be a significant risk factor for [Rating]C1 pressure ulcer development13). According to the 6.Consider using Subjective Global Assessment EPUAP nutritional guidelines, undesirable weight (SGA). loss, defined as weight loss exceeding 10% of normal [Rating]C1 bodyweight over 6 months, or exceeding 5% over 1 [ Analysis ]Normally in a clinical setting, bioche- months, maypoint to malnutrition, and requires mical measures such as serum albumin levels, as well regular monitoring of the patientls bodyweight 14). as physiological parameters, food intake rate, and However, in a systematic review, a weight loss was nutritional assessment and screening tools are used to reported to be related to the occurrence of pressure

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ulcer in only4( 33. 3% )of the 12 studies that impaired, transitional phase to moderatelyimpaired, evaluated the relationship between weight loss and and moderatelyor severelyimpaired ) , and the the occurrence of pressure ulcer8). Therefore, no clear percentage of patients with pressure ulcer was relationship was observed between weight loss and compared. As a result, the percentage was significant- the occurrence of pressure ulcer, and the recom- lyhigher( p<0. 01 )in patients with moderate to mendation level was rated as C1 in consideration of severe impairment(37.5%)than in those with nor- the evidence level. mal or mildlyimpaired nutritional state. The recom- Regarding the relationship between dietaryintake mendation level was rated as C1 based on the and pressure ulcer, a systematic review reported that evidence level. the dietaryintake was related to the occurrence of The Subjective Global Assessment, published by pressure ulcer in 4( 57. 1% )of the 7 studies that Detskyet al. in 1987, is widelyused as a comparatively investigated this relationship8). In Japan, the food precise tool for assessing the nutritional state of intake rate was reported to be 75% or less in 48% of patients. However, it has been assigned the Recom- the patients with pressure ulcer15). Also, in the Braden mendation Rating of C1 due to the fact that at present Scale, the food intake is included as an item of risk onlyexpert opinion supports the relationship between assessment for the occurrence of pressure ulcer, and SGA and pressure ulcer prevention. the risk of pressure ulcer is considered to increase, References particularly, when the food intake rate is 50% or less16). However, according to a studythat evaluated the food 1)Reed RL, Hepburn K, Adelson R, et al : Low serum intake using this scale alone, low food intake was albumin levels, confusion, and fecal incontinence are reported not to be a significant risk factor for pressure these risk factors for pressure ulcers in mobility- ulcer8). Thus, no clear relationship has been observed impaired hospitalized adults?. Gerontology, 49(4): between the food intake rate and the occurrence of 255-259, 2003.(LevelⅣ) pressure ulcer. Moreover, as the food intake rate does 2)Pinchcofsky-Devin GD, Kaminski MV Jr : Correlation not necessarilyreflect the degree of fulfillment of the of pressure sores and nutritional status. J Am Geriatr nutritional requirement, and as it is affected bythe Soc, 34(6):435-440, 1986.(LevelⅣ) method for its assessment, the recommendation level 3)Mino Y, Morimoto S, Okaishi K, et al : Risk factors for was rated as C1 in consideration of the evidence level. pressure ulcers in bedridden elderlysubjects : Concerning the tools for the assessment of the Importance of turning over in bed and serum albumin nutritional state, a cross-sectional studyusing MNA ® level. Geriatr Gerontol Int, 1:38-44, 2001.(LevelⅣ) ( mini nutritional assessment )and a cohort study 4)Nakajo T, Oishi S : Prevention of pressure ulcer and using MNA® -SF( mini nutritional assessment-short nutrition management : Cutoff values of serum form ), a simplified version of MNA, evaluated the albumin and hemoglobin. Geriatr Med, 40(8):1023- usefulness of these tools for the assessment of the risk 1028, 2002.(LevelⅥ)(Japanese) of pressure ulcer in elderlysubjects, and both MNA ® 5)Konagaya M, Takasaki K : The development of nutri- and MNA®-SF were concluded to be useful16, 17). Also, a tional index for pressure ulcer incidence. Jpn J PU, 2 cross-sectional studyof the relationships of MNR ® (3):257-263, 2000.( LevelⅣ )( Japanese, English with other nutritional indices suggested that MNR® abstract) maybe more useful than visceral proteins that reflect 6)Sugiyama M, Nishimura A, Ohura T, et al : Effect of inflammation(albumin, prealbumin)for screening of nutritional care for prevention and treatment for the nutritional state18). Its recommendation level was pressure ulcers : Health and labor sciences Research rated as C1 based on the evidence level. Among Grants(H10-Comprehensive Research on Aging and reports of the use of other tools, there is a report of a Health-012). 37-45, 2000.(LevelⅣ)(Japanese) cross-sectional studyusing a tool for controlling 7)Rochon PA, Beaudet MP, McGlinchey-Berroth R, et nutritional status( CONUT )in inpatients of the al : Risk assessment for pressure ulcers : an adapta- recuperation ward19). In this report, the level of tion of the National Pressure Ulcer AdvisoryPanel nutritional impairment was classified into 3 categories risk factors to spinal cord injured patients. J Am according to the CONUT score( normal or mildly Paraplegia Soc, 16(3):169-177, 1993.(LevelⅡ)

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8)Coleman S, Gorecki C, Nelson EA, et al : Patient risk incidence of decubitus and the infections. Jpn J Med factors for pressure ulcer development : systematic Tech, 58(8):928-933, 2009.(LevelⅤ) review. Int J Nurs Stud, 50( 7 ):974-1003, 2013. (LevelⅠ) CQ 4. 5:When is the systemic administration of 9)Bouillanne O, HayP, Liabaud B, et al : Evidence that antibiotics( antimicrobials )indicated in patients albumin is not a suitable marker of bodycomposition- with an infected pressure ulcer? related nutritional status in elderlypatients. Nutri- [ Recommendation ]If physical examination find- tion, 27(2):165-169, 2011. ings or test results indicate advancing cellulitis and 10)Tanaka Y, Sugino H, Nakanishi H, et al : Is the serum osteomyelitis, necrotizing fasciitis, bacteremia, or albumin level a good index of the nutritional state in sepsis, administering systemic antibiotics may be pressure ulcer patients?. J Metab Clin Nutr, 14(1): considered. If onlysymptomsof local infection are 9-15, 2011.(LevelⅣ) found, administration of systemic antibiotics need not 11)Guenter P, Malyszek R, Bliss DZ, et al : Survey of be considered. nutritional status in newlyhospitalized patients with [Rating]C1 stageⅢ or stage Ⅳ pressure ulcers. Adv Skin Wound [Analysis]An effort was made to identify specific Care, 13(4 Pt 1):164-168, 2000.(LevelⅥ) disease states in cases of infected pressure ulcers 12)Haydock DA, Hill GL : Impaired wound healing in which required the systemic administration of antibio- surgical patients with varying degrees of malnutri- tics. However, given the generallyaccepted notion tion. JPEN J Parenter Enteral Nutr, 10(6):550-554, that failure to administer systemic antibiotics entails 1986.(LevelⅣ) an intolerable risk to the patientls health, there are no 13)Allman RM, Goode PS, Patrick MM, et al : Pressure controlled studies examining the differences in the ulcer risk factors among hospitalized patients with effect of administering or not administering systemic activitylimitation. JAMA, 273( 11 ):865-870, 1995. antibiotics. Our recommendations here are therefore (LevelⅣ) based on published guidelines or reviews. The 14)European Pressure Ulcer AdvisoryPanel : Nutritional NPUAP/EPUAP guidelines recommend using guidelines for pressure ulcer prevention and treat- lsystemic antibiotics for individuals with clinical ment. Registered charityNo : 1066856, European evidence of systemic infection, such as positive blood Pressure Ulcer AdvisoryPanel, 2003. cultures, cellulitis, fasciitis, osteomylelitis, systemic 15)Ohura T, Nakajo T, Okada S, et al : Influence of inflammatoryresponse syndrome,or sepsis, if consis- nutritional intervention to the patients who have risk tent with the individualls goalsl1). The WOCN factors for pressure ulcer. Jpn JPU, 10(2):122-129, guidelines similarlyendorse the view that systemic 2008.(LevelⅣ)(Japanese, English abstract) antibiotics should be administered, as needed, in cases 16)Hengstermann S, Fischer A, Steinhagen-Thiessen E, of bacteremia, sepsis, advancing cellulitis and et al : Nutrition States and Pressure ulcer : What We osteomyelitis2). The AWMA guidelines state,T Use Need for Nutrition. Prenteral and Nutr, 31(4):288- systemic antibiotics when the patient with a pressure 294, 2007.(LevelⅤ) injuryhas clinical evidence of CBR spreading and/or 17)Yatabe MS, Taguchi F, Ishida I, et al : Mini nutritional systemic infectionU3). From a clinical point-of-view, if assessment as a useful method of predicting the the physical examination findings or the test results development of pressure ulcers in elderlyinpatients. are found to correspond to the condition of a given Am Geriatr Soc, 61(10):1698-1704, 2013.(LevelⅣ) patient, consider the administration of systemic 18)Langkamp-Henken B, Hudgens J, Stechmiller JK, et antibiotics. However, for cases in which the infection is al : Mini nutritional assessment and screening scores local, there is no evidence to support the use of are associated with nutritional indicators in elderly systemic antibiotics. For such cases, refer to the people with pressure ulcers. J Am Diet Assoc, 105 sections dealing with conservative treatment or (10):1590-1596, 2005.(LevelⅤ) surgical treatment. 19)Sugimori E, Imasato Y : Search of the nutritional References estimation method in NST activity: The utilityof CONUT scoring method and the correlation with the 1)National Pressure Ulcer AdvisoryPanel and Euro-

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pean Pressure Ulcer AdvisoryPanel : Prevention and diovascular diseases maybe considered as factors treatment of pressure ulcers : clinical practice guide- which mayprolong the healing of pressure ulcers. line, National Pressure Ulcer AdvisoryPanel, [Rating]C1 Washington DC, 2009. [ Analysis ]Evidence relating to co-morbidity di- 2)Wound OstomyContinence Nurses Society: Guide- agnoses was assembled because of their potential lines for prevention and management of pressure importance as factors influencing the healing of ulcers. 2nd edition, WOCN clinical practice guidelines pressure ulcers, including chronic wounds. The series 2, 2010. majorityof the information found was comprised of 3)Australian Wound Management Association : Pan expert opinions and case reports, with onlytwo pacific clinical practice guideline for the prevention analytical-epidemiological and case-controlled and management of pressure injury. Cambridge studies1, 2). Media, Osborne Park WA, 2012. The rate of healing in pressure ulcers among cardiovascular patients was found to be significantly CQ 4. 6: Which antibiotics( antimicrobials )are lower according to a cohort studyof pressure ulcer recommended for treating infection? patients1). According to the findings of another cohort [ Recommendation ]Using empiric antibiotics studyof cancer patients with pressure ulcers and promptlyto suspected pathogens common in clinical other types of skin ulcer2), cancer patients showed a settings maybe considered. Reconsider using more significant lower rate of healing than non-cancer specific antibiotics to pathogens byreferring the patients. Further, according to expert opinion in results of susceptibilitytesting. Japan3), the exacerbation of diabetes mellitus, malig- [Rating]C1 nancies, liver cirrhosis, or peripheral vascular disease [Analysis]There are no studies at present indicat- impeded the healing rate of pressure ulcers. ing the best choice of systemic antibiotic for infected In summary, malignancies and cardiovascular pressure ulcers. In the NPUAP/EPUAP guidelines, diseases can be cited as comorbidityfactors which lAntibiotics should be chosen based on confirmed mayprolong the healing of pressure ulcers. Although antibiotic susceptibilities of the suspected or known specific epidemiological figures cannot be given for pathogens. For life-threatening infections, empiric lack of data, a general care regimen which includes antibiotics should be based on local antimicrobial management of the patientls condition and nutrition is susceptibilitypatterns, and re-evaluated when defini- recommended in order to hasten healing of pressure tive cultures become availablel1). In the present ulcers in patients whose general health has been guidelines as well, the immediate administration of adverselyaffected bytheir disease state. antibiotics appropriate to the suspected pathogen is References recommended. However, infectious disorders such as necrotizing fasciitis is expected to be exacerbated 1)Jones KR, Fennie K : Factors influencing pressure even with the administration of antibiotics appropri- ulcer healing in adults over 50 : an exploratorystudy. ate for the causative microorganisms, its combination J Am Med Dir Assoc, 8(6):378-387, 2007.(Level with surgical debridement must always be evaluated. Ⅳ) 2)McNees P, Meneses KD : Pressure ulcers and other References chronic wounds in patients with and patients without 1)National Pressure Ulcer AdvisoryPanel and Euro- cancer : a retrospective, comparative analysis of pean Pressure Ulcer AdvisoryPanel : Prevention and healing patterns. OstomyWound Manage, 53(2): treatment of pressure ulcers : clinical practice guide- 70-78, 2007.(LevelⅣ) line, National Pressure Ulcer AdvisoryPanel, 3)Mino Y : The latest basic information : How to treat a Washington DC, 2009. refractorypressure ulcer?. JPN J Clin Nurs(Rinsho Kango ), 27(9):1377-1382, 2001.( LevelⅥ ) CQ 4.7:Which underlying conditions may pose a (Japanese) risk of prolonging the healing of pressure ulcers? [ Recommendation ]Malignant tumors and car-

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CQ 4.8:Should a nutritional screening and assess- reduction in wound surface area and a faster wound ment be performed for pressure ulcer patients? healing rate 8 weeks after the intervention than the [ Recommendation ]A nutritional screening and control group, who were given only1. 16 times the assessment and nutritional intervention maybe BEE. Because this studyeliminated factors unrelated considered if required. to nutrition and used the same nutritional source for [Rating]C1 all of its subjects, it merits the Recommendation [Analysis]Assessing the nutritional status of the rating of B. pressure ulcer patient and instituting the nutritional Also, concerning energysupplementation for pa- regimen most appropriate for each case has been tients with stageⅢ−Ⅳ(NPUAP staging)pressure found to contribute to improving the patientls health1). ulcers, sub-analysis of this study showed that cure of The NPUAP/EPUAP quick reference guide2) also pressure ulcer was promoted byaggressive enteral recommends that screening and assessment of the feeding compared with conventional nutritional man- patientls nutritional status be conducted when the agement, and the evaluation of the energyrequire- patient is admitted to hospital, shows changes in ment suitable for the condition of pressure ulcer is health condition, or shows evidence of retardation of considered necessary5). wound healing. With regard to the quantityof protein in the diet, greater reduction in the wound surface area was seen References in patients who had received large quantities of 1)Donini LM, De Felice MR, Tagliaccica A, et al : Nutri- protein(energyratio 25%)via enteral feeding com- tional status and evolution of pressure sores in pared to those who had received onlythe standard geriatric patients. J Nutr Health Aging, 9(6):446- diet6). Further, a group of under-nourished patients 454, 2005.(LevelⅣ) who had received large quantities of protein in their 2)European Pressure Ulcer AdvisoryPanel and Nation- diet either via enteral feeding or as a dietary al Pressure Ulcer AdvisoryPanel : Prevention and supplement( 24% protein ; 61 g/L )reportedly treatment of pressure ulcers : quick reference guide, showed a greater reduction in wound surface area National Pressure Ulcer AdvisoryPanel, Washington after 8 weeks compared to the group who had DC, 2009. received only14% protein( 37 g/L ) 7). However, because the number of subjects was small and the CQ 4.9:How much nutrition in general should be experimental design was inadequate, these data have provided to pressure ulcer patients? been assigned a low Evidence Level. On the other [Recommendation] hand, a randomized controlled studyexamining the 1.In order to ensure adequate energyfor healing effect of providing patients with a diet augmented of pressure ulcers, recommend providing patients with larger quantities of specific nutrients as required, with 1.5 times the basal energyexpenditure(BEE). demonstrated an improved PUSH scores and wound [Rating]B healing rate in the intervention group, although a [Recommendation] comparison of energycontent and amount of added 2.Recommend providing additional protein as protein with wound healing rate and PUSH scores required. showed no difference8). However, the studyemployed [Rating]B a relativelysmall number of cases and failed to explain [ Analysis ]Two systematic reviews have ex- the relationship between individual nutrients, press- amined the effect of nutrition on pressure ulcers1, 2). ure ulcer healing rate, and PUSH scores. The The NPUAP/EPUAP guidelines recommend 30-35 NPUAP/EPUAP guidelines3) recommend 1. 25-1. 5g/ kcal/kg of bodyweight as the basic energy kg/dayaccording to the severityof the symptoms 3), requirement3). A randomized controlled study4) of but because there are no recent studies on the basis of nutritional intervention in patients with pressure which specific recommendations can be made, we ulcers found that the intervention group, who were have not indicated anyspecific amount for protein given 300 kcal in addition to their dailydiet( 1. 55 supplementation. times the BEE ), showed a significantlygreater

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including protein, zinc, and ascorbic acid was per- References formed but showed no significant difference1). 1)Langer G, Schloemer G, Knerr A, et al : Nutritional In the literature about zinc, there is one randomized interventions for preventing and treating pressure controlled trial, which showed no significant differ- ulcers. Cochrane Database Syst Rev, 4 : CD003216, ence in healing of pressure ulcers between the group 2003.(LevelⅠ) administered zinc sulfate and the group administered 2)Stratton RJ, Ek AC, Engfer M, et al : Enteral nutri- placebo2). However, the number of subjects was small, tional support in prevention and treatment of and medical care, dietaryintake, nutritional state, or pressure ulcers:asystematic review and meta- the serum zinc level was unclear. Also, according to analysis. Ageing Res Rev, 4( 3 ):422-450, 2005. the NPUAP/EPUAP guidelines3), supplementation of (LevelⅠ) 40 mg/dayor more zinc in zinc-deficient patients is 3)National Pressure Ulcer AdvisoryPanel and Euro- indicated, but as there is no literature with a high pean Pressure Ulcer AdvisoryPanel : Prevention and evidence level concerning the effect of zinc supple- treatment of pressure ulcers : clinical practice guide- mentation on the cure of pressure ulcers, the line. National Pressure Ulcer AdvisoryPanel, recommendation level was rated as C1. Washington DC, 2009. Concerning the literature on ascorbic acid, there are 4)Ohura T, Nakajo T, Okada S, et al : Evaluation of 2 randomized controlled trials4, 5). One of them4) effects of nutrition intervention on healing of pressure reported that the surface area of pressure ulcer ulcers and nutritional states : randomized controlled decreased significantlyin the group administered trial. Wound Rep Reg, 19 : 330-336, 2011.(LevelⅡ) ascorbic acid compared with the control group(P< 5)Ohura T, Nakajo T, Okada S, et al : Effects of nutrition 0.05). However, it was a small-scale studyof 20 intervention for pressure ulcer patients -Healing rate subjects, and as there is no new literature supporting and speed of wound size and nutrition-. Jpn J Geriatr, the usefulness of the treatment, the recommendation 50(3):377-383, 2013.(LevelⅤ) level was rated as C1. 6)Chernoff RS, Milton KY, Lipschitz DA : The effect of a Concerning the literature about arginine, there are veryhigh-protein liquid formula on decubitus ulcers 3 randomized controlled trials6−8) and 1 historical healing in long term tube-fed institutionalized pa- control study9). In the randomized controlled trials, a tients. J Am Diet Assoc, 90 : A-130, 1990.(LevelⅡ) significant improvement in the PUSH score was 7)Breslow RA, Hallfrisch J, GuyDG, et al : The observed in the group eating a supplement containing importance of dietaryprotein in healing pressure arginine(P<0.05). However, since all 3 randomized ulcers. J Am Geriatr Soc, 41( 4 ):357-362, 1993. controlled trials were small-scale studies with 16-43 (LevelⅡ) subjects, the recommendation level was rated as C1. 8)Cereda E, Gini A, Pedrolli C, et al : Disease-specific, As the literature concerning L-carnosine, there is 1 versus standard, nutritional support for the treatment report of a historical control study10). In the group of pressure ulcers in institutionalized older adults : a administered L-carnosine, the mean weeklyimprove- randomized controlled trial. J Am Geriatr Soc, 57 ment in the PUSH score was significantlygreater( P (8):1395-1402, 2009.(LevelⅡ) <0.05). However, as it was a small-scale studywith 42 subjects, the recommendation level was rated as C1. CQ 4.10:Should the diet of pressure ulcer patients As the literature concerning n-3 fattyacids, there be supplemented with anyspecific nutrients? are 2 randomized controlled study11, 12). The adminis- [ Recommendation ]The diet maybe sup- tration of a nutritional preparation rich in n-3 fatty plemented with zinc, ascorbic acid, arginine, L- acids was effective for the prevention of the occurr- carnosine, n-3 fatty acids, collagen hydrolysate, etc. in ence and exacerbation of pressure ulcers, but no effect consideration of the disease. on the healing of pressure ulcers was noted. There- [Rating]C1 fore, the recommendation level was rated as C1. [ Analysis ]A systematic review of the effect of Concerning collagen hydrolysate, there is one nutritional support on the prevention and treatment report of a randomized controlled trial13). The PUSH of pressure ulcers, meta-analysis concerning nutrients score significantlyimproved in the group adminis-

―G−53― ― 508 ― tered collagen hydrolysate(P<0.05). However, this malnourished patients. Nutrition, 26( 9 ):867-872, studywas carried out with less than 100 subjects, and 2010.(LevelⅡ) the numbers of subjects in the intervention and 7)Desneves KJ, Todorovic BE, Cassar A, et al : control groups were uneven. Therefore, the recom- Treatment with supplementaryarginine, vitamin C mendation level was rated a C1. and zinc in patients with pressure ulcers : a rando- Concerning HMB(β-hydroxy β-methylbutyric mised controlled trial. Clin Nutr, 24( 6 ):979-987, acid ), there is one randomized controlled study14). 2005.(LevelⅡ) Granulation cells and epithelial cells showed signifi- 8)Cereda A, Gini A, Pedrolli C, et al : Disease-specific, cantlymore proliferation in the group administered versus standard, nutritional support for the treatment HMB-containing nutritional supplement compared of pressure ulcers in institutionalized older adults : a with the control group(P<0.05), but no difference randomized controlled trial. J Am Geriatr Soc, 57 was observed in the PUSH score or ulcer size. (8):1395-1402, 2009.(LevelⅡ) Concerning ornithine α-ketoglutarate(OKG), there 9)Brewer S, Desneves K, Pearce L, et al : Effect of an is one randomized controlled trial15). Pressure ulcers arginine-containing nutritional supplement on press- with a size of less than 8 cm2 showed a significant ure ulcer in communityspinal patients. J Wound Care, decrease in size in the group administered OKG 19(7):311-316, 2010.(LevelⅢ) compared with the control group(P<0.05). Howev- 10)Sakae K, Agata T, Kamide R, et al : Effects of L- er, in pressure ulcers 8 cm2 or greater in size, no carnosine and its zinc complex( Polaprezinc )on difference was observed between the two groups. pressure ulcer healing. Nutr Clin Pract, 28(5):609- Outcomes indicating the effectiveness of these 616, 2013.(LevelⅢ) nutrients are awaited. Since nitrogen compounds such 11)Theilla M, Singer P, Cohen J, et al : A diet enriched in as amino acids mayexacerbate the renal function, eicosapentanoic acid, gamma-linolenic acid and anti- theymust be supplied in consideration of the disease, oxidants in the prevention of new pressure ulcer so the recommendation was formulated as,Tmaybe formation in criticallyill patients with acute lung supplemented in consideration of the disease.U injury: A randomized, prospective, controlled study. Clin Nutr, 26(6):752-757, 2007.(LevelⅡ) References 12)Theilla M, Schwartz B, Zimra Y, et al : Enteral n-3 1)Langer G, Fink A : Nutritional interventions for fattyacids and micronutrients enhance percentage of preventing and treating pressure ulcers. Cochrane positive of pressure ulcer healing in criticallyill Database Syst Rev,(6):CD003216, 2014.(LevelⅠ) patients. Brit J of Nutr, 107( 7 ):1056-1061, 2012. 2)Norris JR, Reynolds RE : The effect of oral zinc sulk- (LevelⅡ) fate therapyon decubitus ulcer. J Am Geriatr Soc, 19 : 13)Lee SK, Posthauer ME, Dorner B, et al : Pressure ulcer 793-797, 1971.(LevelⅡ) healing with a concentrated, fortified, collagen protein 3)National Pressure Ulcer AdvisoryPanel and Euro- hydrolysate supplement : a randomized controlled pean Pressure Ulcer AdvisoryPanel : Prevention and trial. Adv Skin Wound Care, 19( 2 ):92-96, 2006. treatment of pressure ulcers : clinical practice guide- (LevelⅡ) line. National Pressure Ulcer AdvisoryPanel, 14)Wong A, Chew A, Wang CM, et al : The use of a Washington DC, 2009. specialised amino acid mixture for pressure ulcers : a 4)Taylor TV, Rimmer S, Day B, et al : Ascorbic acid placebo-controlled trial. J Wound Care, 23(5):259- supplementation in the treatment of pressure-sores. 260, 2014.(LevelⅡ) Lancet, 2(7880):544-546, 1974.(LevelⅡ) 15)Meaume S, Kerihuel JC, Constans T, et al : Efficacy 5)Ter Riet G, Kessels AG, Knipschild PG : Randomized and safetyof ornithine alpha-ketoglutarate in heel clinical trial of ascorbic acid in the treatment of pressure ulcers in elderlypatients : results of a pressure ulcers. J Clin Epidemiol, 48( 12 ):1453- randomized controlled trial. J Nutr Health Aging, 13 1460, 1995.(LevelⅡ) (7):623-630, 2009.(LevelⅡ) 6)van Anholt RD, Sobotka L, Meijer EP, et al : Specific nutritional support accelerates pressure ulcer healing CQ 4.11:Should a registered dietician or multidisci- and reduces wound care intensityin non- plinarynutritional team participate in the care of

―G−54― 褥瘡会誌(2016) ― 509 ― pressure ulcer patients? nutritional management on the long term hospitalized [ Recommendation ]Participation bya registered patients. Jpn J National Med Service, 59(6):300- dietician or multidisciplinarynutrition support team 305, 2005.(LevelⅤ)(Japanese) in the care of pressure ulcer patients maybe 5)European Pressure Ulcer AdvisoryPanel : Nutritional recommended. guidelines for pressure ulcer prevention and treat- [Rating]C1 ment. Registered charityNo : 1066856, European [Analysis]A studyof the economic viabilityof a Pressure Ulcer AdvisoryPanel, 2003. nutrition support team( NST )in pressure ulcer management1)found that two years after deployment, CQ 4.12:Should bodyweight be used as a means of the incidence of pressure ulcers fell from 14. 9% to assessing the efficacyof nutritional supplementation 5.85%(roughly1/3 of the original rate)in the study in pressure ulcer patients? population and that the cost of treating pressure [ Recommendation ]Recommend using body ulcers substantiallyfell in the second yearof the weight as a means of assessing the effectiveness of NSTls operations. Two other studies have reported nutritional supplementation if edema or dehydration similar findings with regard to the economic viability can be ruled out. of the NST2, 3). Another studyreported 4) an improve- [Rating]B ment in the patientsl condition as a result of [Analysis]A randomized controlled study examin- intervention bythe NST, but because the number of ing the effectiveness of nutritional intervention in cases was small, no statistical data were given. pressure ulcer patients found that the intervention The EPUAP nutritional guidelines recommend that group showed a significantlygreater increase in body for gradeⅢ and Ⅳ pressure ulcers, a multi- weight 12 weeks after commencement of the study disciplinaryteam assess the basic metabolic rate of compared with the control group(p<0.001), which the patient and monitor the amount of exudates from showed little change in bodyweight 1). Further, the the wound5). wound size in the intervention group decreased more All of the studies examined are unanimous in rapidlythan in the control group( p<0. 001 ). The asserting the need for preventive intervention and results of this studyhave been deemed reliable recommend appropriate nutritional assessment, as because factors unrelated to nutrition but affecting well as intervention bythe registered dietician or the the pressure ulcers were controlled. Accordingly, NST. However, none of the studies mentioned gives bodyweight is recommended as an index for specific data concerning the efficacyof this form of assessing whether the patient has received adequate intervention in promoting pressure ulcer healing. nutrition. Further, the NPUAP/EPUAP guidelines2) recom- References mend that, if the bodyweight of a pressure ulcer 1)Okude K, Higashiguchi T, Fukumura S, et al : patient decreases, the patient should be given Economic effect of pressure ulcers management sufficient calories to restore bodyweight. However, based on nutrition therapy. J Jpn Soc Parenteral edema and dehydration should first be ruled out as Enteral Nutrition, 17( 4 ):29-33, 2002.( LevelⅤ ) potential causes of fluctuations in bodyweight. (Japanese, English abstract) References 2)Onoki K, Isozaki T, Yonekawa O, et al : Medical economic effect of nutrition support team(NST)in 1)Ohura T, Nakajo T, Okada S , et al : Evaluation of a general hospital in Japan. Med J Seirei Hamamatsu effects of nutrition intervention on healing of pressure General Hospital, 4( 1 ):23-27, 2004.( LevelⅤ ) ulcers and nutritional states : randomized controlled (Japanese) trial. Wound Repair Regen, 19 : 330-336, 2011.(Level 3)Toma T, Kitanishi M, Hasegawa K : Clinical outcomes Ⅱ) of femoral neck fracture with nutrition support team. 2)National Pressure Ulcer AdvisoryPanel and Euro- Central Japan J of Orthopaedic Surgery& Traumatol- pean Pressure Ulcer AdvisoryPanel : Prevention and ogy, 48(4):659-660, 2005.(LevelⅤ)(Japanese) treatment of pressure ulcers : clinical practice guide- 4)Ohara H, Kurihara Y, Dohi M : Improvement effect of line. National Pressure Ulcer AdvisoryPanel,

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Fig. 6 Algorithm illustrating preventive care options

Fig. 7 Algorithm illustrating care options after occurrence of pressure ulcer

Washington DC, 2009. thrombosis, presence of pneumonia, historyof press- ure ulcers, to be relevant factors. No relationship was CQ 5 Rehabilitation found between age and degree of injury. Among CQ 5.1:Which factors account for pressure ulcer studies conducted in Japan, some have reported that development in chronic spinal cord injurypatients? all pressure ulcers recur within 14 years2), or that the [Recommendation]For patients with a historyof recurrence maylead to sepsis or death 3). The pressure ulcers, vigilance is recommended to prevent Recommendation Rating of B is assigned to these recurrence. evidence sources in view of the apparentlyserious [Rating]B consequences of recurrence. [ Analysis ]A systematic review1) which has ex- References amined the factors leading to pressure ulcer develop- ment among chronic spinal cord injurypatients found 1)Gelis A, Dupeyron A, Legros P, et al : Pressure ulcer gender(greater susceptibilityof men), length of time risk factors in persons with spinal cord injuryPart2 : following appearance of the wound, complete injury The chronic stage. Spinal Cord, 47:651-661, 2009. rather than partial injury, the presence of deep vein (LevelⅠ)

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2)Hirose H, Niituma J, Iwasaki Y, et al : An approach to seating cushion for a person with spinal cord injury determine situations in which pressure ulcers occur and hip disarticulation. J Jpn Acad Prosthetists in patients with spinal cord injury. Jpn J PU, 12(2): Orthotists, 12(1):48-53, 2004.(LevelⅤ)(Japanese) 118-125, 2010.( LevelⅣ )( Japanese, English ab- 4)Kaneko M, Nakashima M, Kurosaki S, et al : Indi- stract) viduallyplanned visits for self-care guidance and 3)Imai K, Kadowaki T, Aizawa Y : Standardized indices livelihood support byco-medical staff could prevent of mortalityamong persons with spinal cord injury: pressure ulcer recurrence in a patient with spinal Accelerated aging process. Ind Health, 42(2):213- injury. Jpn J PU, 132-136, 2010.(LevelⅤ)(Japanese, 218, 2004.(LevelⅣ) English abstract)

CQ 5.2:Which methods are effective for prevent- CQ 5.3:What type of cushion should be used with ing pressure ulcer development in spinal cord injury elderlypatients in a seated position to prevent patients? pressure ulcers? [ Recommendation ]Conducting rehabilitation [Recommendation] while monitoring interface pressure maybe consi- 1.A pressure-redistributing seat cushion for dered. individuals with spinal cord injuryis recommended to [Rating]C1 prevent pressure ulcer development while seated. [Analysis]Hirose et al1). have compared the length [Rating]B of time that elapsed between discharge from hospital 2.The use of a dynamic cushion may be evaluated. following treatment for pressure ulcers and readmis- [Rating]C1 sion for recurrence among patients who received [Analysis]A randomized controlled trial compar- rehabilitation either with or without monitoring ing the efficacyof three typesof pressure- interface pressure. The results of the studydemons- redistributing seat cushions designed for spinal cord trated a significantlylower incidence of recurrence injurypatients with that of a segmented foam cushion among patients when their interface pressure was ( 8cm in thickness )in preventing pressure ulcers1) monitored during rehabilitation( p<0. 02 ). Further, found that while the rate of pressure ulcer develop- three separate studies2−4) on pressure ulcer preven- ment decreased significantlyin the tissue overlying tion for spinal cord injurypatients performed at the ischial bone as a result of the use of pressure- multiple rehabilitation facilities in Japan reported that redistributing seat cushions(p=0.04), there was no seat-type pressure measuring devices are extremely measurable change in the rate of pressure ulcer useful in gauging pressure on the buttocks and in development in the coccyx and sacral areas. However, providing feedback to the patient during rehabilita- there is a case report published in Japan claiming that tion. On this basis, we have assigned the recommenda- the application of a segmented air cushion 10 cm in tion rating of C1 to this section. thickness to the ischial area of three elderlypatients did not result in the development of pressure ulcers2). References On the basis of these data, the methods discussed here 1)Hirose H, Niituma J, Iwasaki Y, et al : An approach to are assigned a recommendation rating of B. determine situations in which pressure ulcers in There is a case report that pressure ulcers showed patients with spinal cord injury. Jpn J PU, 12(2): a tendencyto heal as the patients regularlysat up in 118-125, 2010.( LevelⅣ )( Japanese, English ab- the wheelchair for about 1 hour at each meal using a stract) dynamic cushion3). There are also three case series 2)Morita T, Maeda J, Sakuma F, et al : A case studyof a reports comparing dynamic and static cushions in spinal cord injury( SCI )patient who developed a healthysubjects( crossover experimental studies ). pressure ulcer after changing his wheelchair cushion One studycompared a dynamiccushion was com- and life-style-Physical therapy intervention of the pared with a static air-cell cushion in elderlysubjects treatment of pressure ulcer in SCI-. Physical Therapy and showed that the maximum bodypressure 30 Japan, 35(3):104-109,2008.(LevelⅤ)(Japanese) minutes after the beginning of sitting was significant- 3)Matsubara H, Hirose H, Hama Y : Fabrication of lylower, and the contact area was significantlywider,

―G−57― ― 512 ― with the dynamic cushion4). Another studycompared placed near their beds1). The studyindicated that the contact pressure and cutaneous blood flow limiting sitting time to two hours or less resulted in a diffusion in 8 subjects and found a lower maximum significantlylower rate of pressure ulcer formation pressure and more satisfactorycutaneous blood flow compared to unlimited sitting time(p<0.001). The diffusion with a dynamic cushion5). In the last study, NPUAP/EPUAP guidelines, which cite the same similar comparison was made in 17 subjects, and the study, assign the data a recommendation rating of B reactive hyperemia index was significantly lower with and endorse the view that seating time should be a dynamic cushion while no difference was observed limited, although theydo offer specific recommenda- in the maximum pressure6). From these findings, the tions on the length of sitting time2). Also, a systematic recommendation level was rated as C1. review that evaluated the risk of the use of the wheelchair in elderlyindividuals suggested the References duration of sitting as a risk factor of the occurrence of 1)Brienza D, KelseyS, Karg P, et a l : A randomized pressure ulcer3). clinical trial on preventing pressure ulcers with On the basis of these considerations, we have also wheelchair seat cushions. J Am Geriatr Soc, 58:2308- decided to recommend onlythat seating time be 2314, 2010.(LevelⅡ) limited without offering anyspecific recommenda- 2)Hirose H, Tanaka H, Mawaki A, et al : Case studies of tions regarding permissible seating time. coccygeal pressure ulcers caused by improper References wheelchair seating. Jpn J PU, 13( 1 ):54-60, 2011. (LevelⅤ)(Japanese, English abstract) 1)Gebhardt K, Bliss MR : Preventing pressure sores in 3)Fukuda M, Tabata K, Ichikawa Y, et al : Effect of a orthopedic patients is prolonged chair nursing dynamic cushion on healing of pressure ulcer : A case detrimental. J Tissue Viability, 4( 2 ):51-54, 1994. studyof a chair-bound elderlyindividual with a D3 (LevelⅡ) pressure ulcer on the left ischial tuberosity. J Soc 2)National Pressure Ulcer AdvisoryPanel and Euro- Nurs Pract, 25(1):96-101, 2013.(LevelⅤ) pean Pressure Ulcer AdvisoryPanel : Prevention and 4)Fujikawa J, Nakagami G, Akase T, et al : Evaluation of treatment of pressure ulcers : clinical practice guide- pressure redistribution using new dynamic cushion line. National Pressure Ulcer AdvisoryPanel, for the elderly. Jpn JPU,12(1):28-35, 2010.(Level Washington DC, 2009. Ⅴ) 3)Sotomura M, Shirai M : Literature Review about Risks 5)Stockton L, RithaliaS:Isdynamic seating a modality and Risk Factors Associated with ElderlyWheelchiar worth considering in the prevention of pressure Users. Osaka CityUnivers J Nurs, 9:45-52, 2013. ulcers?. J Tissue Viability, 17( 1 ):15-21, 2008. (LevelⅠ) (LevelⅤ) 6)Nakagami G, Sanada H, Sugama J : Development and CQ 5. 5:At what intervals should the seated evaluation of a self-regulating alternating pressure air individual be repositioned? cushion. Disabil Rehabil Assist Technol, 10(2):165- [Recommendation]Repositioning every15 min is 169, 2015.(LevelⅤ) recommended for seated individuals who are capable of changing their bodyposition without assistance. CQ 5.4:Should limitations be set on the length of [Rating]C1 time in which the individual remains continuously [Analysis]There are no published studies to date seated? addressing the question of optimal intervals for body [ Recommendation ]Elderlyindividuals unable to repositioning for wheelchair-bound individuals who reposition without assistance are recommended to are capable of changing their bodyposition without limit the duration of continued sitting. assistance. However, the WOCN guidelines1), as well [Rating]B as the Centers for Medicare and Medicaid2), recom- [Analysis]A randomized controlled trial involving mend an interval of 15 minutes. 57 patients in two orthopaedic wards examined the On the basis of this information, we recommend effect of limiting the time patients could sit in chairs that wheelchair-bound individuals capable of reposi-

―G−58― 褥瘡会誌(2016) ― 513 ― tioning on their own do so at regular 15 minute References intervals, although it should be noted that there is no clear evidence endorsing this recommendation. 1)Hirose H, Tanaka H, Mawaki A, et al : Case studies of coccygeal pressure ulcers caused by improper References wheelchair seating. Jpn J PU, 13( 1 ):54-60, 2011. 1)Ratliff CR, Bryant DE : Wound, Ostomy, and Conti- (LevelⅤ)(Japanese, English abstract) nence Nurses Society(WOCN):Guideline for pre- 2)National Pressure Ulcer AdvisoryPanel and Euro- vention and management of pressure ulcers. WOCN pean Pressure Ulcer AdvisoryPanel : Prevention and clinical practice guideline No.2. WOCN, Glenview, IL, treatment of pressure ulcers : Clinical practice 2003. guideline. National Pressure Ulcer AdvisoryPanel, 2)CMS Manual System : Pub. 100-07 State Operations, Washington DC, 2009. Provider Certification, Transmittal 4. Guidance to 3)AHCPR : AHCPR Supported clinical practice guide- Surveyors for Long Term Care Facilities, https:// lines. 3. Pressure ulcers in adults : Prediction and www.cms.gov/Regulations-and-Guidance/Guidance/ prevention, Clinical practice guideline Number 3, Transmittals/Downloads/R5SOM.pdf, 2004. AHCPR Pub. No.92-0047. 4)Sugiyama M, Kubota K, Kiyomiya K, et al : Wheel- CQ 5. 6:Should the individualls posture while chair cushion selection in patients with spinal cord seated be considered? injuryand hip joint contractures. Jpn JPU, 15(1): [Recommendation]The alignment and balance of 48-52, 2013.(LevelⅤ) the seated individualls bodyshould be considered. [Rating]C1 CQ 5.7:Should donut-type devices be used? [Analysis]To date there exist only one case report [ Recommendation ]Donut-type devices are not and two guidelines addressing the question of the recommended. effect that prolonged sitting has on pressure ulcers. [Rating]D According to the case report1), three patients at a [Analysis]A case report investigating the effect of nursing home for elderlywith shallow ulcers in the various types of cushion on the development of coccygeal area underwent rehabilitation with the pressure ulcers in hospitalized elderlypatients assistance of a trained physical therapist who chose indicated that donut-shaped devices either conduced bodypositions and support surfaces according to to the development of pressure ulcers or worsened exercise physiological principles to lessen pressure on existing cases1). The NPUAP/EPUAP guidelines the wounds. As a result of this treatment, the pressure similarlyrecommend,kAvoid use of syntheticsheeps- ulcers healed successfullyeven while the patients kin pads ; cutout, ring, or donut type devices ; and remained in their wheelchair. The NPUAP/EPUAP water-filled gloves l2). The WOCN guidelines also guidelines recommendk selecting a posture that is state,kAvoid foam rings, foam cutouts, or donut type acceptable for the individual and minimizes the devicesl3). pressures and shear exerted on the skin and soft The preponderance of evidence suggests that tissuesl2). The WOCN guidelines also stateTspecial donut-shaped devices should be avoided ; recom- attention to the individualls anatomy, postural align- mendation rating D. ment, distribution of weightU3). Moreover, there is a References case report in which the wheelchair cushion was selected byexamining the asymmetryofthe posture 1)Crewe RA : Problems of rubber ring nursing cushions and inclination of the pelvis4). and a clinical surveyof alternative cushions for ill On the basis of the above information, measures to patients. Care Sci Pract, 5(2):9-11, 1987.(LevelⅤ) prevent pressure ulcer development can be im- 2)National Pressure Ulcer AdvisoryPanel and Euro- plemented even while the patient remains confined to pean Pressure Ulcer AdvisoryPanel : Prevention and a sitting position ; recommendation rating C1. treatment of pressure ulcers : clinical practice guide- line. National Pressure Ulcer AdvisoryPanel, Washington DC, 2009.

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3)AHCPR : AHCPR Supported clinical practice guide- perceptions of an implanted neuroprosthesis for lines. 3. Pressure ulcers in adults : prediction and exercise, standing, and transfers after spinal cord prevention, Clinical practice guideline Number 3, injury. J Rehab Res Develop, 40(3):241-252, 2003. AHCPR Pub. No.92-0047. (LevelⅤ) 3)Giangregorio L, McCartneyN : Bone loss and muscle CQ 5.8:What kind of physical modality can be used atrophyin spinal cord injury: Epidemiology,fracture to treat muscular atrophy? prediction, and rehabilitation strategies. J Spinal Cord [ Recommendation ]Consider using electric sti- Med, 29(5):489-500, 2006.(LevelⅥ) mulation therapy. [Rating]C1 CQ 5.9:What kind of therapeutic exercise can be [ Analysis ]There is a case report1) and a case used to treat joint contracture? series2) examining the use of neuromuscular electric [Recommendation]Consider using passive range stimulation therapyto treat muscular atrophy.Bogie of motion exercises. et al.1) performed electric stimulation therapyin the [Rating]C1 gluteus maximus muscle of a 42-year-old patient 22 [Analysis]Four randomized controlled studies1-4) years after spinal cord injury(C4)with a history of discuss the use of therapeutic exercise to treat joint GradeⅣ pressure ulcer and reported that there was contracture in individuals at risk of developing no skin trouble for 2 years thereafter and that the pressure ulcers. Moseleyet al. 1)performed an RCT to patient could work part-time. Also, Sanjeev et al.2) compare the effectiveness of therapeutic programs performed electric stimulation therapyusing im- including and not including passive traction(short- planted electrodes for the acquisition of activities of time/long-time)in patients with cast immobilization dailyliving and reported a decrease in the occurrence of the ankle and reported no difference between the of pressure ulcer in patients with the risk of pressure two groups. Steffen et al.2)compared treatment using ulcer. All these studies onlyreported maintenance of a device that could applyprolonged mild traction and the muscle thickness and changes in dailylife and did manual passive traction in elderlypatients with not mention the preventive effect of the treatment on flexion contracture of the bilateral knees and reported pressure ulcer. Giangregorio et al.3) reviewed the no difference between the two treatments. Harveyet literature concerning loss of bone mass and muscle al.3) performed an RCT of treatments with and atrophyin patients with spinal cord injuryand without 30-minute dailystretching for 4 weeks in showed that electric stimulation therapywas effective patients with spinal cord injuryand reported no for maintaining/increasing the muscle cross-sectional difference. Fox et al.4) evaluated the therapeutic area, but theydid not report the preventive effect of effects of positioning on the bed in elderlypatients the treatment on pressure ulcer. All studies that with flexion contracture of the knees byan RCT with reported a decrease in the risk of pressure ulcer used a cross-over design and reported no difference electric stimulation with implanted electrodes, and the compared with the no-intervention group. While there evidence is insufficient to affirm a preventive effect of are multiple RCTs concerning intervention bypassive electric stimulation using surface electrodes on exercise, the treatment was insufficient for prevent- pressure ulcer although the treatment maybe ing joint contracture. Therefore, the recommendation effective for the prevention of muscle atrophy. level of passive exercise was rated as C1. Therefore, the recommendation level was rated as C1. References References 1)AM Moseley, RD Herbert, EJ Nightingale, et al : 1)Bogie KM, Wang X, Triolo RJ : Long-term prevention Passive stretching does not enhance outcomes in of pressure ulcers in high-risk patients : A single case patients with plantar flexion contracture after cast studyof use of gluteal neuromuscular electric immobilization for ankle fracture : a randomized stimulation. Arch Phys Med Rehabil, 87( 4 ):585- controlled trial. Arch Phys Med Rehabil, 86( 6 ): 591, 2006.(LevelⅤ) 1118-1126, 2005.(LevelⅡ) 2)Sanjeev A, Triolo RJ, Kobetic R, et al : Long-term user 2)TM Steffen, LA Mollinger : Low-load, prolonged sty-

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retch in the treatment of knee flexion contractures in References nursing home residents. Phys Ther, 75( 10 ):886- 897, 1995.(LevelⅣ) 1)Buss IC, Halfens RJ, Abu-Saad HH : The effectiveness 3)HarveyLA, BattyJ, Crosbie J, et a l : A randomized of massage in preventing pressure sores : a literature trail assessing the effects of 4 weeks of daily review. Rehab Nursing, 22( 5 ):229-234, 242, 1997. stretching on ankle mobilityin patients with spinal (LevelⅠ) cord injuries. Arch Phys Med Rehabil, 81( 10 ): 2)Duimel-Peeters IG, Halfens RJ, Berger MP, et al : The 1340-1347, 2000.(LevelⅡ) effects of massage as a method to prevent pressure 4)Fox P, Richardson J, MCInners B, et al : Effectiveness ulcers. A review of the literature. OstomyWound of a bed positioning program for treating older adults Manage, 51(4):70-80, 2005.(LevelⅠ) with knee contractures who are institutionalized. 3)Duimel-Peeters IG, JG Halfens R, Ambergen AW, et Phys Ther, 80(4):363-372, 2000.(LevelⅡ) al : The effective of massage with and without dimethyl sulfoxide in preventing pressure ulcers : A CQ 5.10:Should tissue overlying bony prominen- randomized, double-blind cross-over trial in patients ces be massaged? prone to pressure ulcers. Int J Nurs Stud, 44(8): [ Recommendation ]Massaging areas covering 1285-1295, 2007.(LevelⅡ) bonyprominences is not recommended. 4)Catherine R Ratliff : WOCNNs evidence based press- [Rating]D ure ulcer guideline. Adv Skin Wound Care, 18(4): [ Analysis ]Two systematic reviews1, 2) and one 204-208, 2005. randomized controlled trial3) examine the use of massage in pressure ulcer care and management. CQ 5.11:How can dailyuse of the wheelchair by Buss et al.1) reviewed 10 papers and concluded that patients with shallow pressure ulcers be facilitated? massaging improved the skin temperature and [Recommendation]A suitable sitting posture, an subcutaneous blood flow but cannot be recommended appropriate support cushion, and limitation on sitting for the prevention of pressure ulcer to patients at a time maybe considered. high risk of developing pressure ulcer. Duimel- [Rating]C1 Peeters et al.2) reviewed 12 papers and summarized [Analysis]To date there exist two case reports1, 2) them as follows : While positive results have been and one guideline3) addressing the question of what reported concerning the skin temperature and effect a sitting posture has on pressure ulcers. subcutaneous blood flow, the differences were not According to the first case report1), three patients at statisticallysignificant, and manypapers supported an elderlycare facilitywith shallow ulcers in the the attitude that massaging of areas with bone coccygeal area underwent rehabilitation with the protrusion should be avoided. Duimel-Peeters et al.3) assistance of a trained physical therapist who chose performed a randomized cross-over studyin 144 bodypositions and support surfaces according to patients at a high risk for pressure ulcer with a kinesiologyto lessen pressure on the pressure ulcers. Braden score of 20 or above. The incidences of As a result of this procedure, the pressure ulcers pressure ulcer in Periods 1 and 2 were 41.9 and 13.6%, healed successfullyeven while the patients remained respectively, with massaging in the control group, 62. in their wheelchair. In the other case report2), the 1 and 12.0% with massaging using DMSO cream, but patient had D3 pressure ulcer but showed a tendency 38.9 and 5.9% bychanging the bodyposition alone, to cure while continuing life in the seated position by showing no difference according to the use of cream using dynamic cushions. The NPUAP/EPUAP or compared with changing the bodyposition alone. guidelines3) recommend re-evaluating the patients' The WOCN guidelines4) also state that strong pressure ulcer state, and on the basis of the findings, massaging should be avoided. In summary, the selecting an appropriate cushion, limiting sitting time, evidence given above generallyindicates that massag- and determining the effects of posture to avoid ing bonyprominences should be avoided ; recom- pressure on the wound area to enable the patient to mendation rating D. continue using the wheelchair. For these reasons, the methods described above are assigned the recom-

―G−61― ― 516 ― mendation rating of C1. 3)Ho CH, Bensitel T, Wang X, et al : Pulsatile lavage for the enhancement of pressure ulcer healing : A References randomized controlled trial. Physical Therapy, 92 1)Hirose H, Tanaka H, Mawaki A, et al : Case studies of (1):38-48, 2012.(LevelⅡ) coccygeal pressure ulcers caused by improper wheelchair seating. Jpn J PU, 13( 1 ):54-60, 2011. CQ 5. 13:What kind of physical modality can be (LevelⅤ)(Japanese, English abstract) used for pressure ulcers containing necrotic tissue? 2)Fukuda M, Tabata K, Ichikawa Y,et al : Effect of a [Recommendation]Consider hydrotherapy or pul- dynamic cushion on healing of pressure ulcer : A case satile lavage with or without suction. During bed rest, studyof a chair-bound elderlyindividual with a D3 a vibrator maybe used with a bodypressure pressure ulcer on the left ischial tuberosity. J Soc dispersion mattress. Nurs Pract, 25(1):96-101, 2013.(LevelⅤ) [Rating]C1 3)National Pressure Ulcer AdvisoryPanel and Euro- [Analysis]Based on expert opinion, the NPUAP/ pean Pressure Ulcer AdvisoryPanel : Prevention and EPUAP guidelines1) state to consider a course of treatment of pressure ulcers : Clinical practice whirlpool as an adjunct for wound cleansing and guideline. National Pressure Ulcer AdvisoryPanel, facilitating healing. The same guidelines further state Washington DC, 2009. to consider a course of pulsatile lavage with suction for wound cleansing and debridement. In Japan the CQ 5. 12:What kind of physical modality can be Hubbard tank is used in wound cleansing procedures, used for patients with infected pressure ulcers? but no studies assessing its efficacyhave been [Recommendation]Hydrotherapy and pulsed lav- published to date. While the cure rate of pressure age/suction maybe performed. ulcers has been reported to be improved bypulsed [Rating]C1 lavage/suction2), indices of debridement were not [Analysis]The NPUAP/EPUAP guidelines state included in the evaluation items, and the mechanism considering a course of whirlpool for reducing of cure cannot be identified. Given these considera- bioburden and infection1). Although hydrotherapy tions, the methods described here have been assigned providing agitation and turbulence to the water by the recommendation rating of C1. In Japan, also, the mixing air and water byturbines in a tank has not decrease in necrotic tissue was reported to be been found to effective in suppressing infection, accelerated bythe use of a vibrator in addition to a according to expert opinion2)it is effective in reducing bodyweight dispersion mattress during bed rest bya the bacterial load in wounds, therebypromoting semi-randomized controlled trial3). Since the long- wound healing. While an improvement in the healing term effect of the treatment is unclear, and the rate of pressure ulcers bypulsed lavage/suction number of reports is small, the recommendation level therapyhas been reported 3), the evaluation items did was rated as C1. not include an index of improvement in infection, and References the mechanism of healing cannot be identified. For this reason this form of therapyhas been assigned the 1)National Pressure Ulcer AdvisoryPanel and Euro- recommendation rating of C1. pean Pressure Ulcer AdvisoryPanel : Prevention and treatment of pressure ulcers : clinical practice guide- References line. National Pressure Ulcer AdvisoryPanel, 1)National Pressure Ulcer AdvisoryPanel and Euro- Washington DC, 2009. pean Pressure Ulcer AdvisoryPanel : Prevention and 2)Ho CH, Bensitel T, Wang X, et al : Pulsatile lavage for treatment of pressure ulcers : clinical practice guide- the enhancement of pressure ulcer healing : A line. National Pressure Ulcer AdvisoryPanel, randomized controlled trial. Physical Therapy, 92 Washington DC, 2009. (1):38-48, 2012.(LevelⅡ) 2)Burke D, Ho C, Saucier M, et al : Effects of hydro- 3)Ueda A, Sugama J, Okuwa M, et al : Effects of therapyon pressure ulcer healing. Am J PhysMed vibration on the healing of pressure ulcers with Rehabil, 77(5):394-398, 1998.(LevelⅣ) necrotic tissue. Jpn JPU, 12( 2 ):111-117, 2010.

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(LevelⅢ) therapy17) has reported less than adequate results for this form of therapy, in a case report, Maeshige et al.18) CQ 5. 14:What kind of physical modality can be state that ultrasound therapyhad a positive effect on used to promote wound reduction? reducing wound size. For this reason, ultrasound [Recommendation] therapyhas been assigned the recommendation 1.Implementing electrical stimulation therapyis rating of C1. Non-thermal pulsed electromagnetic recommended. therapy19)showed a positive effect on the reduction of [Rating]B wound size, but this modalityis assigned the 2.Near infrared therapy, ultrasonic therapy, or recommendation rating of C1 due to the small size of electromagnetic therapymaybe considered. Also, randomized clinical trial. In Japan, the cure rate and during bed rest, a vibrator maybe used in addition to wound size reduction rate of stage I pressure ulcers a bodyweight dispersion mattress. were reported to be significantlyincreased bythe use [Rating]C1 of a vibrator in addition to a bodypressure dispersion [Analysis]Two meta-analyses1, 2)and one systema- mattress20). Since this studywas a non-randomized tic review3) have compared the relative efficacyof controlled study, the recommendation level was rated electrical stimulation therapyand conventional ther- as C1. apies for treating pressure ulcers, including chronic References ulcers. The recommended parameters for electrical stimulation therapydiverge widelyin these studies, 1)Gardner S, Frantz R, Schmidt F : Effect of electrical but the results reported for this form of treatment are stimulation on chronic wound healing : A meta- uniformlypositive. Reductions in wound size have also analysis. Wound Repair Regen, 7(6):495-503, 1999. been reported byrandomized controlled trials using (LevelⅠ) direct current stimulation4), direct micro-current 2)Polak A, Franek A, Taradaj J : High-voltage pulsed stimulation5), and high-voltage pulsed electric current electrical stimulation in wound treatment. stimulation6, 7). While there have been reports of case Adv Wound Care, 3(2):104-117, 2014.(LevelⅠ) studies8−10), a self-controlled study11), and a randomized 3)Regan MA, RW Teasell, DL Wolfe, et al:Asystematic controlled trial in Japan, the recommendation level review of therapeutic interventions for pressure was rated as B, because of the absence of a ulcers after spinal cord injury. Arch Phys Med multicenter study. Rehabil, 90 : 213-231, 2009.(LevelⅠ) Of the studies examining the effect of phototherapy 4)Iwamoto E : Clinical effects of transcutaneous electric- on pressure ulcer, two randomized controlled trial12, 13) al nerve stimulation in patients with pressure ulcers. and one case report14) specificallyexamine the use of Jpn JPU, 13(4):551-557, 2011.(LevelⅡ) near infrared therapy. These studies have found near 5)Stefanovska A, Vodovnik L, Benko H, et al : Treat- infrared therapyto be effective in promoting wound ment of chronic wound bymeans of electric and reduction. Although near infrared irradiation was electromagnetic fields. Part2. Value of FES para- found to increase blood flow in the wound periphery meters for pressure sore treatment. Med Biol Eng with significantlypositive effects on wound healing 14), Comput, 31(3):213-220, 1993. the mechanism underlying this phenomenon has not 6)Pamela E, Karen E, Campbell RN, et al : Electrical yet been explained and for this reason this technique Stimulation TherapyIncreases Rate of Healing of has been assigned a recommendation rating of C1. Pressure Ulcers in Community-Dwelling People With Ultrasound/ultraviolet-C irradiation has been found to Spinal Cord Injury. Arch Phys Med Rehabil, 91(5): reduce wound size15), but the wayin which each 669-678, 2010. intervention produces these results has not been 7)Recio AC, Felter CE, Schneider AC, et al : High- clarified. In addition, the two randomized controlled voltage electrical stimulation for the management of trials examining the efficacyof low-level laser StageⅢ and Ⅳ pressure ulcers among adults with irradiation on wound healing has not reported spinal cord injury: Demonstration of its utilityfor significant improvement15, 16). recalcitrant wounds below the level of injury. J Spinal Although the systematic review of ultrasound Cord Med, 35(1):58-63, 2012.(LevelⅡ)

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8)Yoshikawa Y, Sugimoto M, Maeshige N,et al : Clinical on wound healing of pressure ulcers in spinal cord- application of direct micro-current stimulation to injured patients : A randomized, double-blind study. sacral pressure ulcer. Jpn JPU, 14(4):582-586, 2012. Wounds, 7(1):11-16, 1995. (LevelⅤ) 20)Arashi M, Sugama J, Sanada H, et al : Vibration 9)Yoshikawa Y, Sugimoto M, Maeshige N,et al : Effect of therapyaccelerates healing of Stage I pressure ulcers Direct Micro-current on Pressure Ulcer with Under- in older adult patients. Adv Skin Wound Care, 23 mining. Jpn Soc Physio Ther, 19 : 82-86, 2012.(Level (7):321-327, 2010.(LevelⅢ) Ⅴ) 10)Honda H, Sugimoto M, Maeshige N,et al : Efficacyof CQ 6 Risk assessment galvanic pulsed stimulation for healing of pressure CQ 6.1:Is risk assessment effective in predicting ulcer-A single-case design-. Jpn JPU, 14( 1 ):64-67, the development of pressure ulcers? 2012.(LevelⅤ) [Recommendation]Use of risk assessment scales 11)Yoshikawa Y, Sugimoto M, Maeshige N,et al : The is recommended for predicting pressure ulcer de- Promotional Effect of Low-intensityDirect Current velopment. Stimulation with Electrode Placement of Negative [Rating]B Poles at Wound Site on Pressure Ulcer Healing. J Jpn [Analysis]Deeks1) published a systematic review Phys Ther Assoc, 40(3):200-206, 2013.(LevelⅣ) in which the validityof seven risk assessment scales, 12)Schubert V : Effects of phototherapyon pressure namely, the Norton, Gosnell, Knoll, Braden, Waterlow, ulcer healing in elderlypatients after a falling trauma. Pressure Sore Predictor Scale(PSPS), and Andersen A prospective, randomized, controlled study. Photo- scales, were evaluated in terms of the parameters of dermatol Photoimmunol Photomed, 17( 1 ):32-38, sensitivity, specificity, and pressure sore incidence 2001. rates. However, differences in sample size and target 13)Dehlin O, Elmstahl S, Gottrup F : Monochromatic population varied widelyaccording to scale, rendering phototherapyin elderlypatient s : A new wayof their relative utilityfor predicting, and therefore treating chronic pressure ulcers?. Aging Clin Exp preventing, pressure ulcer occurrence unclear at best. Res, 15(3):259-263, 2003. On the other hand, the occurrence of pressure ulcers 14)Kurokawa M, Yamada N, Hanemori Y, et al : Effect of can be reduced if the appropriate preventive in- linear polarized near infrared therapyfor pressure terventions are conducted on the basis of information ulcers. Geriat Med, 40( 8 ):1165-1170, 2002. obtained from risk assessment scales. (Japanese) Another systematic review2) assessing the Braden, 15)Nussbaum EL, Biemann I, Mustard B : Comparison of Norton, and Waterlow scales in terms of the para- ultrasound/ ultraviolet-C and laser for treatment of meters of clinical judgment and predictive validity pressure ulcers in patients with spinal cord injury. subjected the odds ratio of the three scales(4.08, 2.16, Phys Ther, 74(9):812-823, 1994. and 2.05, respectively)and the odds ratio of clinical 16)Lucas C, van Gemert MJ, de Haan RJ : Efficacyof low- judgment(1.69)to meta-analysis and found that the level laser therapyin the management of stageⅢ risk assessment scale was effective in predicting the decubitus ulcers : A prospective, observer-blinded occurrence of pressure ulcers. Moreover, in a sys- multicentre randomized clinical trial. Lasers Med Sci, tematic review of a wider range of reports(year of 18(2):72-77, 2003. publication, predictive scale)and limited to prospec- 17)Flemming K, Cullum N K, Cullum N, et al : Therapeu- tive studies, the Braden scale, Norton scale, Waterlow tic ultrasound for pressure ulcer. Cochrane Database scale, Cubbin-Jackson scale, EMINA scale, and PSPU Syst Rev, Issue 4, 2009. scale were compared with clinical prediction of the 18)Maeshige N, Terashi H, Sugimoto M, et al : Evaluation occurrence of pressure ulcer bymeta-analysisaccord- of combined use of ultrasound irradiation and wound ing to the relative risk(RR)3). The RRs of the scales dressing on pressure ulcer. J Wound Care, 19(2): were 4.26, 3.69, 2.66, 8.36, 6.17, and 21.4, respectively, 63-68, 2010. and that of clinical judgments was 1.89. 19)Salzberg CA, Stephanie A, Francisco JP, et al : The The above reports suggest that the incidence of effects of non-thermal pulsed electromagnetic energy pressure ulcer can be reduced bypredicting the

―G−64― 褥瘡会誌(2016) ― 519 ―

occurrence of pressure ulcers on the basis of clinical in both predicting pressure ulcer occurrence as well judgments in combination with risk assessment scales as reducing costs associated with pressure ulcer care. rather than alone and coupling them with appropriate As such, the adoption of this scale is recommended as preventive intervention. part of a prevention program.

References References

1)Deeks JJ : Pressure sore prevention : Using and 1)Defloor T, Grydonck MFH : Pressure Ulcers : valida- evaluating risk assessment tools. Br J Nurs, 5(5): tion of two risk assessment scales. J Clin Nurs, 14 313-320, 1996.(LevelⅠ) (3):373-382, 2005.(LevelⅣ) 2)Pancorbo-Hidalgo PL, Garcia-Fernandez FP, Lopez- 2)Brown SJ : The Braden Scale. A review of the re- Medina IM, et al : Risk assessment scales for pressure search evidence. Orthop Nurs, 23(1):30-38, 2004. ulcer prevention:asystematic review. J Adv Nurs, 54 (LevelⅠ) (1):94-110, 2006.(LevelⅠ) 3)Bergstrom N, Braden B, Boynton P, et al : Using a 3)García-Fernández FP, Pancorbo-Hidalgo PL, Agreda research-based assessment scale in clinical practice. JJ : Predictive capacityof risk assessment scales and Nurs Clin North Am, 30(3):539-551, 1995.(Level clinical judgment for pressure ulcers : a meta- Ⅳ) analysis. J Wound Ostomy Continence Nurs, 41(1): 24-34, 2014.(LevelⅠ) CQ 6. 3:What method of assessment used for elderlypatients? CQ 6. 2:Which risk assessment scale should [Recommendation]Assessing the risk factors for generallybe used? pressure ulcer development maybe considered. [ Recommendation ]Use of the Braden Scale is [Rating]C1 recommended for most situations. [Analysis]A retrospective cohort study1) studied [Rating]B the odds ratios for the six risk factors of the [Analysis]The efficacy of the Braden Scale and occurrence pressure ulcers( basic mobility, morbid the Norton Scale for predicting pressure ulcer bonyprominence, articular contracture, malnutrition, occurrence was examined in a cohort studyusing two skin moisture, edema)stipulated bythe Ministryof randomlyassigned groups, thek turning group lin Health, Labor, and Welfare in Supplement No.4 of the which subjectskbodyposition was rotated, and the Clinical Practice for Pressure Ulcer Development knon-turning groupl1). The results showed that the (March 6, 2006)in 173 bedridden patients bylogistic subjects in the non-turning group developed GradeⅡ regression analysis using the above factors as or higher pressure ulcers at a significantlyhigher rate covariates. The odds ratios were 2.7 for morbid bony than the turning group. Further, a comparison of the prominence, 11. 2 for articular contracture, 1. 2 for sensitivity, specificity, and the odds ratio of both malnutrition, 1.3 for skin moisture, and 2.0 for edema, scales, when applied to the non-turning group, indicating articular contracture to be the most demonstrated the equivalence of these two scales. important risk factor. An Internet search usingkBraden Scalelas the The Ministryof Health, Labour and Welfare keyword produced a systematicreview 2) of nine presented standards for the management of pressure studies dealing with the predictive validityof the ulcer and recommended the assessment of risk factors Braden Scale. However, due to the fact that the cut-off for pressure ulcer according to Supplement No. 3 of value varied widelyfrom 14-20 points, no agreement the Clinical Practice for Pressure Ulcer Development could be found among these studies. issued with the 2014 revision of medical treatment Another article3) dealing with a cohort studyusing fees. the Braden Scale found that use of this scale enabled a References 50-60% reduction in the incidence of pressure ulcers, as well as reductions in costs associated with specialty 1)Kaigawa K, Moriguchi T, Oka H, et al : Analysis of the bed rentals and pressure reduction mattress overlays. pressure ulcer risk in bedridden patients, Jpn JPU, 8 In summary, the Braden Scale has proved effective (1):54-57, 2006.(LevelⅣ)(Japanese, English ab-

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stract) CQ 6. 5:Which risk assessment scale is recom- mended for pediatric patients? CQ 6. 4:Which risk assessment scale is recom- [Recommendation]The Braden Q Scale maybe mended for use with the elderly? considered for risk assessment in pediatric patients. [Recommendation] [Rating]C1 1.The OH Scale maybe used with bedridden [Analysis]A prospective cohort study1) was con- elderlypatients. ducted in 332 pediatric patients in PICU with no [Rating]C1 historyof pressure ulcer or congenital heart disease [Recommendation] (CHD)(aged 21 days to 8 years)to determine the 2.The K Scale maybe used with bedridden elderly predictive validityand cut-off value of the Braden Q patients in hospital. Scale. With a cut-off value of 16, the sensitivitywas 88. [Rating]C1 0%, and the specificitywas 58. 0%, warranting [Analysis]A case control report1)using the Ohura recommendation of preventive intervention. Risk Assessment Scale to evaluate four risk factors, There is also a retrospective cohort studythat namely, the state of consciousness, degree of sacral evaluated the predictive validityin patients admitted bonyprominence, edema, and articular contracture in to PICU bystratifyingthem byage and dividing them 95 pressure ulcer patients and 318 non-pressure ulcer according the presence or absence of CHD2).In patients found a significant difference between the patients aged 3 weeks to 8 years, with a cut-off value total average score for the pressure ulcer group(6.7) of 16, the sensitivityand specificitywere reported to and that of the non-pressure ulcer group(3.4). The be 66.7% and 75.4%, respectively, in those with CHD Ohura Risk Assessment Scale has since been revised (516 patients)and 100% and 73.1%, respectively, in and is now accepted as an highlyaccurate OH scale. those without CHD(282 patients). The accuracyof The reliabilityand predictive validityof the K Scale this scale was high in children with no CHD. have been examined in a prospective cohort studyof References hospitalized bedridden elderlypatients 2). The study found that in terms of reliability, the K Scale did not 1)CurleyMAQ, Razmus IS, Roberts KE, et al : require as high a level of experience or skill in the user Predicting pressure ulcer risk in pediatric patients : as the Braden Scale. Further, an assessment of the The Braden Q Scale. Nurs Res, 52(1):22-33, 2003. predictive validityof the K Scale found the specificity (LevelⅣ) of the underlying subscales to be 29.0% whereas that 2)Tume LN, Siner S, Scott E, et al : The prognostic of the trigger subscales was 74. 2%. These results abilityof earlyBraden Q Scores in criticallyill demonstrated the clinical significance of the K Scale children. Nurs Crit Care, 19( 2 ):98-103, 2014. as an effective tool for predicting the development of (LevelⅣ) pressure ulcers byobserving the changes in interface pressure, moisture, and shear within a short period of CQ 6. 6:Which risk assessment scale is recom- time. mended for spinal cord injurypatients? [ Recommendation ]The SCIPUS scale maybe References considered for risk assessment in spinal cord injury 1)Fujioka M, Hamada Y : Usefulness of the Ohura risk patients. assessment scale for predicting pressure ulcer [Rating]C1 development, Jpn JPU, 6(1):68-74, 2004.(LevelⅣ) [Analysis]The Spinal Cord Injury Pressure Ulcer (Japanese, English abstract) Scale(SCIPUS)comprises 15 parameters : level of 2)Okuwa M, Sanada H, Sugama J, et al : The Reliability activity, mobility, complete spinal cord injury, urine and Validityof the K Scale for Predicting Pressure incontinence or constantlymoist, autonomic dysrefle- Ulcer Development for the Elderly. Jpn JPU, 3(1): xia or severe spasticity, age, tobacco use/smoking, 7-13, 2001.(LevelⅣ)(Japanese, English abstract) pulmonarydisease, cardiac disease or abnormal ECG, diabetes or hyperglycemia, renal disease, impaired cognitive function, internment in a nursing home or

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hospitalization, albumin or total protein, and hematoc- [Rating]C1 rit(hemoglobin). A retrospective cohort study1) of [Recommendation] the efficacyof this scale for pressure ulcer risk 3.The ABI(ankle brachial index)maybe used to assessment in spinal cord injurypatients reported a predict the depth of pressure ulcers in the heel region. high degree of reliabilityand validity.However, it [Rating]C1 should be borne in mind that as no similar studyhas [Analysis]Sato, et al.1)have examined the develop- been conducted in Japan, results mayvarywhen the ment of non-blanchable erythema characterizing scale is used with Japanese subjects. StageⅠ pressure ulcers(NPUAP)in order to deter- mine the utilityof clinical signs for pressure ulcer References prognosis. From their observations, theyconcluded 1)Salzberg CA, Byrne DW, Cayten CG, et al:Anew that the presence of double erythema( graduated pressure ulcer risk assessment scale for individuals redness ), non-blanchable erythema confirmed by with spinal cord injury. Am J Phys Med Rehabil, 75 glass plate compression, erythema away from a bony (2):96-104, 1996.(LevelⅣ) prominence, or expanding erythema predicted the development of tissue defects penetrating to the CQ 6. 7:Which risk assessment scale is recom- dermis or even to underlying tissue. In particular, the mended for subjects in a home-care setting? prognostic value of double erythema and erythema [Recommendation]A pressure ulcer risk assess- awayfrom a bonyprominence for StageⅠ pressure ment scale specificallydesigned for patients in a home ulcers was extremelyhigh, and helpful in predicting care setting maybe used. the deterioration of d1 pressure ulcers. [Rating]C1 In their studyof 12 cases, Aoi, et al. determined that [Analysis]The Pressure Ulcer Risk Assessment the level of deep tissue injurycould be predicted on Scale for the Home Care Setting(home care setting the basis of an initial macroscopic observation of the version of the K Scale)combines the K Scale with patient and ultrasound findings2). The studyrelied on care capacityassessment. A prospective cohort four types of images, among which those of the study1) using this scale rated its predictive validity discontinuous fascia and heterogeneous hypoechoic veryhighly.However, as this studywas conducted in areas had greatest diagnostic value. Further, ultraso- a medium-sized city, differences in results may be nographyproved useful for predicting tissue loss in expected due to variations in familystructure and cases where the depth of the pressure ulcer was care capacity. These considerations need to be borne otherwise unclear. In addition, there is one paper that in mind before using this scale. retrospectivelyevaluated the results of assessment bycombining thermographyand ultrasound images References of patients who developed deep tissue injury(DTI) 1)Murayama S, Kitayama Y, Okuwa M, et al : Develop- obtained from earlyafter the appearance of pressure ment of a pressure ulcer risk assessment scale for the ulcer3). In pressure ulcers that advanced to DTI,Tthe home-care setting. Jpn J PU, 9( 1 ):28-37, 2007. temperature being higher at the ulcer site than the (LevelⅣ)(Japanese, English abstract) surrounding areasUandTheterogeneous hypoechoic areas Uwere common findings. Earlyprediction of CQ 7 Skin assessment DTI is possible bya combination of thermographyand CQ 7.1:How can the depth of pressure ulcers be ultrasonography. predicted? Another studyof 27 cases of pressure ulcer in the [Recommendation] heel region examined the relationship between ABI 1.The prediction of d1 pressure ulcer prognosis ( Ankle Brachial Index )findings at the initial ex- maybe based on the presence of double erythema amination and the final stage of pressure ulcer (graduated redness)awayfrom a bonyprominence. development4). The ABI value for d1 and d2 pressure [Rating]C1 ulcers in the heel region was 0.87, and 0.48 for wounds [Recommendation] of level D3 or deeper in the heel region. The ROC 2.Ultrasonographymaybe used. analysis yielded an ABI outlier value of 0.6. The ABI

―G−67― ― 522 ― can be used to predict the depth of pressure ulcers in References the heel region. In conclusion, the accuracyof the prognosis of 1)Vanderwee K, Grypdonck M, De Bacquer D, et al : pressure ulcer progression can be increased through The reliabilityof two observation methods of close observation of erythema and the use of methods nonblanchable erythema, Grade 1 pressure ulcer. such as ultrasonographyand ABI. Appl Nurs Res, 19(3):156-162, 2006.(LevelⅤ)

References CQ 7. 3:Which methods can be used to identify 1)Sato M, Sanada H, Konya C, et al : Prognosis of stage I deep tissue injury(DTI)? pressure ulcers and related factors. Int Wound J, 3 [Recommendation] (4):355-362, 2006.(LevelⅤ) 1.Palpate the area to see whether pain, induration, 2)Aoi N, Yoshimura K, Kadono T, et al : Ultrasound edema, or changes in skin temperature( warm or assessment of deep tissue injuryin pressure ulcers : cool )are present in comparison with the adjacent Possible prediction of pressure ulcer progression. tissue. Plast Reconstr Surg, 124(2):540-550, 2009.(Level [Rating]C1 Ⅴ) [Recommendation] 3)Higashino T, Nakagami G, Kadono T, et al : Combina- 2.Consider using ultrasonography. tion of thermographic and ultrasonographic assess- [Rating]C1 ments for earlydetection of deep tissue injury.Int [ Analysis ]According to the National Pressure Wound J, 11(5):509-516, 2014.(LevelⅤ) Ulcer AdvisoryPanel( NPUAP )classification, a 4)Okuwa M, Sanada H, Sugama J, et al : Relationship suspected Deep Tissue Injury(DTI)is categorized between heel pressure ulcer severityand the ankle askpurple a or maroon localized area of discolored brachial index among bedfast elderlypatient. Jpn J P intact skin or blood-filled blister due to damage of U, 9( 2 ):177-182, 2007.( LevelⅤ )( Japanese, En- underlying soft tissue from pressure and/or shear. glish abstract) The area maybe preceded bytissue that is painful, firm, mushy, boggy, warmer or cooler as compared to CQ 7.2:How can redness/d1 stage pressure ulcer adjacent tissue.lAlthough the NPUAP advisorypanel be identified? states that the extent of deep soft tissue damage may [Recommendation]The transparent disk method be difficult to detect from skin surface appearance, or the finger method maybe considered. theydiscuss changes in skin sensation and assess- [Rating]C1 ment bypalpation as valid clinical findings 1). The [Analysis]Acontrolled studybyVanderwee et al. clinical findings from palpation mayprovide useful examined the reliabilityand diagnostic accuracyof information for identifying DTI. the transparent disk method and the finger method Ultrasonographycan be used as an objective means for identifying StageⅠ pressure ulcers( EPUAP )1). of assessing DTI, according to one case report2). The The concordance rate of the two methods was higher use of the CT scan, MRI, or ultrasonography, in than 90%, and Cohenls k co-efficient was higher than addition to macroscopic observation and palpation, is 0.6, both indicating a high level of agreement. In terms recommended for an objective assessment of the of diagnostic accuracyas well, these methods yielded condition. Of these various methods, onlyultraso- a veryhigh degree of agreement irrespective of the nographyis mentioned in connection with pressure attending nursesllength of experience. ulcer assessment. Although at present there are no further high- References evidence-level reports on the topic, both of the methods discussed here, namelythe transparent disk 1)Black J, Baharestani MM, Cuddigan J, et al : National method and the finger method, as well as palpation, Pressure Ulcer AdvisoryPanel. National Pressure can be considered for use in identifying redness/d1 Ulcer AdvisoryPanells update pressure ulcer staging pressure ulcer because of the ease with which they system. Adv Skin Wound Care, 20( 5 ):269-274, can be performed in a clinical setting. 2007.

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2)Nagase T, Koshima I, Maekawa T, et al : Ultrasonog- passim 2001.(LevelⅡ) raphic evaluation of an unusual perianal induration : a 2)Thompson P, Langemo D, Anderson J, et al : Skin care possible case of deep tissue injury. J Wound Care, 16 protocols for pressure ulcers and incontinence in long- (8):365-367, 2007.(LevelⅤ) term care : A quasi-experimental study. Adv Skin Wound Care, 18 : 422-429, 2005.(LevelⅢ) CQ 8 Skin care 3)Clever K, Smith G, Bowser C, et al : Evaluating the CQ 8.1:What kind of skin care is recommended for efficacyof a uniquelydelivered skin protectant and its patients suffering from urinaryand/or fecal inconti- effect on the formation of sacral/buttock pressure nence in order to prevent development of pressure ulcer. OstomyWound Manage, 48(12):60-67, 2002. ulcers? (LevelⅢ) [ Recommendation ]After cleansing with an 4)DealeyC : Pressure sores and incontinenc e : a study appropriate cleansing agent, skin emollients can be evaluating the use of topical agents in skin care. J applied to the anal/genital area and to the peripheral Wound Care, 4 : 103-105, 1995.(LevelⅢ) skin. 5)Hunter S, Anderson J, Hanson D, et al : Clinical Trail [Rating]C1 of a prevention and treatment protocol for skin [ Analysis ]Incontinence is associated with the breakdown in two nursing homes. J Wound Ostomy occurrence of superficial pressure ulcers( partial Continence Nurs, 30(5):250-258, 2003.(LevelⅢ) thickness wounds). One randomized controlled study compared the severityof pressure ulcers in inconti- CQ 8. 2:What type of preventive skin care is nent patients following the use of soap or a mildly recommended for use on bonyprominences in elderly acidic cleansing agent1). The results of this study patients? indicated a significant reduction in the occurrence of [ Recommendation ]The application of GradeⅠ pressure ulcers( pressure ulcers without polyurethane film dressing, dressings with sliding skin defect )following the use of the mildlyacidic function, and polyurethane foam/soft silicone dressing cleansing agent. Two non-randomized clinical trials2, 3) is recommended. and one historical control study4) examined the [Rating]B incidence of pressure ulcers after cleansing only, or [ Analysis ]According to one study, transparent after the application of skin emollients to the anal and film dressings applied to the sacral area resulted in a genital areas and to the peripheral skin. In both significant decrease in the rate of occurrence of groups the incidence of pressure ulcers declined ; in pressure ulcers1). When comparison was made be- one study, however, no statistically significant differ- tween the results with and without the application of a ence was reported3). A before-and-after comparison of dressing material with sliding function to the bilateral 136 subjects interned in a long-term care facilityfound greater trochanters, pressure ulcer was not observed that the number of cases of skin trouble declined from in either group, but the incidence of sustained 68 to 40 subjects, while the rate of occurrence of Stage reddening was significantlylower in the group with Ⅰ and Ⅱ pressure ulcers declined from 19.9% to 8.1% the dressing material with sliding function2). (p<0.01)5). Some of the skin care products mentioned Recently, polyurethane foam/soft silicone dressing in the sources cited are unavailable here in Japan material applied to areas of bonyprominence has been although comparable products can be obtained. reported to be effective for the prevention of pressure On the basis of the above data, the application of ulcers3−9). Theywere mainlystudies in patients skin emollients to the anal/genitalia area to the admitted to the ICU not restricting the subjects to peripheral skin after cleansing with an appropriate elderlypatients, but the incidence of pressure ulcer cleansing agent is assigned a recommendation rating was reduced bythe application of the material to of C1. areas of bonyprominence. Thus, the recommendation level of the application References of polyurethane film dressing, dressing materials with 1)Cooper P, GrayD : Comparison of two skin care sliding function, or polyurethane foam/soft silicone regimes for incontinence. Br J Nurs, 10:S6, S8, S10 dressing was rated as B. However, the absence of

―G−69― ― 524 ― insurance coverage must be considered in their use. anishi et al. compared the rate of occurrence of post- operative pressure ulcers in supine patients with and References without transparent film dressings1). Of the 103 1)Ito Y, Yasuda M, Yone J, et al : Polyurethane film subjects without the dressings, 22 developed pressure dressing applied to the sacral area for prevention of ulcers, whereas in the 98 subjects with dressings, only pressure ulcers. Jpn J PU, 9(1):38-42, 2007.(Level 10 developed pressure ulcers, demonstrating a Ⅳ)(Japanese, English abstract) statisticallysignificant difference between the two 2)Nakagami G, Sanada H, Konya C, et al : Evaluation of a groups(p=0.049). However, in view of the fact that new pressure ulcer preventive dressing containing the BMI of all of the subjects was within the normal ceramide 2 with low frictional outer layer. J Adv Nurs, range, the relevance of these results to patients with 59(5):520-529, 2007.(LevelⅢ) pronounced bonyprominences cannot be ascertained. 3)Moore ZEH, Webster J : Dressings and topical agents In summary, the transparent film dressing is for preventing pressure ulcers. Cochrane Database recommended for application to the sacral area in Syst Rev,(8):CD009362, 2013.(LevelⅠ) patients who will undergo surgeryin a supine 4)Clark M, Black J, Alves P, et al : Systematic review of position ; Rating C1. However, it should be noted that the use of prophylactic dressings in the prevention of this form of treatment is not covered byJapanese pressure ulcers. Int Wound J, 11(5):460-471, 2014. National Health Insurance. (LevelⅠ) References 5)Black J, Clark M, DealeyC, et al : Dressings as an adjunct to pressure ulcer prevention : consensus 1)Imanishi K, Morita K, Matsuoka M, et al : Prevention panel recommendations. Int Wound J, 12(4):484- of postoperative pressure ulcer bya polyurethane 488, 2015.(LevelⅡ) film patch. J Dermatol, 33(3):236-237, 2006.(Level 6)Santamaria N, Gerdtz M, Sage S, et al : A randomised Ⅱ) controlled trial of the effectiveness of soft silicone multi-layered foam dressings in the prevention of CQ 8.4:What kind of skin care is recommended for sacral and heel pressure ulcers in trauma and non-invasive ventilation patients to prevent pressure criticallyill patients : the border trial. Int Wound J, 12 ulcer formation at the face mask contact site? (3):302-308, 2013.(LevelⅡ) [Recommendation]A transparent film dressing or 7)Brindle CT, Wegelin JA : Prophylactic dressing a hydrocolloid dressing may be used for this purpose. application to reduce pressure ulcer formation in [Rating]C1 cardiac surgerypatients. J Wound OstomyConti- [ Analysis ]Weng examined the rate of pressure nence Nurs, 39(2):133-142, 2012.(LevelⅣ) ulcer occurrence in 90 non-invasive ventilation 8)Chaiken N : Reduction of sacral pressure ulcers in the patients1). The subjects were divided into three intensive care unit using a silicone border foam groups, namelythe control group and the transparent dressing. J Wound OstomyContinence Nurs, 39(2): film and hydrocolloid dressing groups and the rate of 143-145, 2012.(LevelⅤ) occurrence of StageⅠ pressure ulcers among them 9)Walsh NS, Blanck AW, Smith L, et al : Use of a sacral was compared. The rate of pressure ulcer occurrence silicone border foam dressing as one component of a was 96. 7% in the control group, 53. 3% in the pressure ulcer prevention program in an intensive transparent film dressing group, and 40% in the care unit setting. J Wound OstomyContinence Nurs, hydrocolloid dressing group, showing a significant 39(2):146-149, 2012.(LevelⅤ) difference with the control group(p<0.01). In Japan also, one case report examined the use of CQ 8.3:What kind of skin care is recommended for hydrocolloid dressings with patients placed on a non- patients undergoing surgeryin a supine position? invasive respirator and found evidence of pressure [ Recommendation ]A transparent film dressing ulcer formation in onlytwo of the 30 cases examined 2). can be applied to the sacral area. Pressure ulcers resulting from the use of medical [Rating]C1 devices( medical device related pressure ulcer : [ Analysis ]In a randomized controlled trial, Im- MDRPU)have previouslybeen cited as a matter of

―G−70― 褥瘡会誌(2016) ― 525 ― concern. The present guidelines have therefore (3):302-308, 2013.(LevelⅡ) included discussion of this topic as well. 2)Brindle CT, Wegelin JA : Prophylactic dressing application to reduce pressure ulcer formation in References cardiac surgerypatients. J Wound OstomyConti- 1)Weng MH : The effect of protective treatment in nence Nurs, 39(2):133-142, 2012.(LevelⅣ) reducing pressure ulcers for non-invasive ventilation 3)Chaiken N : Reduction of sacral pressure ulcers in the patients. Intensive Crit Care Nurs, 24(5):295-299, intensive care unit using a silicone border foam 2008.(LevelⅢ) dressing. J Wound OstomyContinence Nurs, 39(2): 2)Tanaka M, Sakaki Y : Prevention of pressure ulcer in 143-145, 2012.(LevelⅤ) the nose/cheeks due to mask application in non- 4)Walsh NS, Blanck AW, Smith L, et al : Use of a sacral invasive positive pressure ventilation -Effects of the silicone border foam dressing as one component of a use of a skin barrier-. Jpn J PU, 10(1):35-38, 2008. pressure ulcer prevention program in an intensive (LevelⅤ) care unit setting. J Wound OstomyContinence Nurs, 39(2):146-149, 2012.(LevelⅤ) CQ 8.5:What kind of skin care should be given to patients under intensive care for the prevention of CQ 8. 6:How should the skin surrounding a pressure ulcers? pressure ulcer be cleansed in order to promote [ Recommendation ]The application of pressure ulcer healing? polyurethane foam/soft silicone dressing is recom- [Recommendation]Cleansing with a mildlyacidic mended. cleansing agent maybe considered. [Rating]B [Rating]C1 [ Analysis ]There is one randomized controlled [ Analysis ]Skin surrounding a pressure ulcer trial that compared the incidence of pressure ulcers contains insoluble proteins, lipids and other contami- with and without the application of polyurethane nants, and therefore requires cleansing in the same foam/soft silicone dressing in patients under intensive manner as healthyskin 1). One studycomparing the care1). The subjects were 440 patients aged 18 years rate of healing in pressure ulcers before and after a and above with no lesion in the calcaneal or sacral regimen of cleansing peripheral skin using either a region transferred from the emergencydepartment sterile saline solution or a mildlyacidic cleansing to the ICU. Pressure ulcer occurred in 27 of the 221 agent found that the latter shortened the healing time patients in the no application group but in 7 of the 219 of pressure ulcers at anystage 2). Further, the rate of patients in the application group with a significant healing among cases of StageⅡ pressure ulcers difference in the incidence(P=0.002). Although not cleansed with the mildlyacidic cleansing agent was reporting a significant difference, there is one cohort 1.79 times faster than the sterile saline solution group. study2)and two case series3, 4)that reported a decrease As yet there are no reports as to the specific types in the incidence of pressure ulcers in the group that of cleansing agents that promote healing in pressure received preventive application of polyurethane ulcers. However, one studycomparing the effect of a foam/soft silicone dressing. mildlyacidic cleansing agent and a mildlyacidic Therefore, the application of polyurethane foam/ ceramide-containing cleansing agent reported a soft silicone dressing is recommended with a recom- reduction in the quantityof scales and microbes as mendation level of B. However, the absence of well as an increase in the amount of ceramide after insurance coverage must be considered in its use. use of the mildlyacidic ceramide-containing cleansing agent3). Accordingly, if maintaining the normal References physiological function of the skin is sufficient to 1)Santamaria N, Gerdtz M, Sage S, et al : A randomised prevent epithelialization of the skin surrounding the controlled trial of the effectiveness of soft silicone wound, a mildlyacidic cleansing agent containing multi-layered foam dressings in the prevention of skin-protective agents is the best option. Absent this sacral and heel pressure ulcers in trauma and option, a mildlyacidic cleansing agent is preferred to criticallyill patients : the border trial. Int Wound J, 12 conventional soap. A cleaning agent that has entered

―G−71― ― 526 ― the wound during cleaning of the skin around Wound Care, 18(8):422-429, 2005. pressure ulcer should be washed off with a wound 2)DealeyC : Pressure sores and incontinence : a study cleaning fluid such as saline and lukewarm water. In evaluating the use of topical agents in skin care. J summary, a mildly acidic cleansing agent is the Wound Care, 4(3):103-105, 1995. preferred option for cleansing the skin surrounding a 3)Bale S, Tebble N, Jones V, et al : The benefits of pressure ulcer wound in order to promote wound implementing a new skin care protocol in nursing healing ; Rating C1. homes. J Tissue Viability, 14(2):44-50, 2004.

References CQ 9 Repositioning 1)Konya C, Sanada H, Sugama J, et al : Skin debris and CQ 9. 1:How frequentlyshould the bed bound micro-organisms on the periwound skin of pressure patient be repositioned to prevent pressure ulcer? ulcers and the influence of periwound cleansing on [Recommendation]Basically, repositioning at least microbial flora. OstomyWound Manage, 51(1):50- every2 hours is recommended. 59, 2005.(LevelⅤ) [Rating]B 2)Konya C, Sanada H, Sugama J, et al : Dose the use of a [ Analysis ]There are two systematic reviews cleanser on skin surrounding pressure ulcer in order concerning repositioning for the prevention of press- people healing?. J wound care, 14(4):169-171, 2005. ure ulcers1, 2). Regarding the interval of repositioning, (LevelⅢ) the results of repositioning every2 hours and every3 3)Ishikawa S, Togashi H, Tamura S, et al : Influence of hours on a standard mattress of the hospital were new skin cleanser containing synthetic pseudo- compared, and the relative risk of the occurrence of ceramide on the surrounding skin of pressure ulcers. pressure ulcer(categories 1-4)was reported to be Jpn J PU, 5(3):508-514, 2003.(LevelⅢ) 0.90 ( 95% CI : 0. 69-1. 16 )with no significant difference1). The results of repositioning at longer CQ 8.7:In cases with urinaryand/or fecal inconti- intervals could not be compared because of the nence, what kind of skin care is recommended to differences in the mattresses used2). promote pressure ulcer healing? Further, the NPUAP/EPUAP guidelines state that, [Recommendation]Skin emollients can be applied kRepositioning frequencywill be determined bythe to the peripheral skin after cleansing with an individualls tissue tolerance, his/her level of activity appropriate cleansing agent. and mobility, his/her general medical condition, the [Rating]C1 overall treatment objectives, and assessments of the [Analysis]Two non-randomized controlled studies individualls skin conditionl3). The WOCN guidelines comparing healing time between a control group recommend to schedule regular repositioning and whose skin was cleansed using a cleansing agent only turning for bed and chair bound individuals4). Both and an experimental group whose skin was covered guidelines recommend implementation of reposition- with a protective cream after cleansing found that ing with assessment of the patientls condition. There healing time shortened and the healing rate improved have been no large-scale studies in risk groups for significantlyin the latter group 1, 2). pressure ulcer in Japan. It must also be considered On the basis of these data, in order to promote that the present guidelines are applied to a wide range pressure ulcer healing, the application of skin of care environments including home, institution, and emollients on the peripheral skin is recommended in hospital. cases of fecal and/or urinaryincontinence, as with For these reasons, the recommendation level was prevention of pressure ulcers, following cleansing rated as B. with an appropriate cleansing agent. References References 1)Gillespie BM, Chaboyer WP, Mcinnes E, et al : 1)Thompson P, Langemo D, Anderson J, et al : Skin care Repositioning for pressure ulcer prevention in adults, protocols for pressure ulcers and incontinence in long- Cochrane Database Syst Rev, 2014.(LevelⅠ) term care : a quasi-experimental study. Adv Skin 2)Chou R, Dana T, Bougatsos C, et al : Pressure ulcer

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risk assessment and prevention:Asystematic their bodysize, weight, and other factors, from their comparative effectiveness review. Ann Intern Med, counterparts in Japan, and for this reason the 159(1):28-38, 2013.(LevelⅠ) application of the methods outlined in the aforemen- 3)National Pressure Ulcer AdvisoryPanel and Euro- tioned studies to patients in Japan mayentail some pean Pressure Ulcer AdvisoryPanel : Prevention and risk, and offer no guarantee of yielding similar results. treatment of pressure ulcers, clinical practice guide- On the other hand, a case controlled studydealing line, National Pressure Ulcer AdvisoryPanel, with patients in a convalescent hospital assessed the Washington DC, 2009. development of erythema among patients supinely 4)Wound, Ostmyand Continence Nurses Society: positioned on a double-layer air-cell mattress overlay4). Guideline for prevention and management of press- The patients were repositioned at intervals of two ure ulcers. WOCN clinical practice guidelines no. 2 hours or greater, and their skin was observed at 2, 4, Glenview, IL, 2003. and 5 hours from commencement of the experiment for indications of erythema. As a result, 4 hours was CQ 9.2:How frequentlyshould bed bound patient found to be the upper limit at which patients could be be repositioned when a support surface is being used? maintained in one position without the development of [Recommendation] erythema. After 5 hours, 50% of patients were found 1.When a visco-elastic foam mattress is used, to have developed indications of erythema. Recently, repositioning at an interval of 4 hours or less is in Japan, a wide varietyof air mattresses have become recommended. available, and these results maynot universallyapply. [Rating]B The NPUAP/EPUAP guidelines state that,TFre- [Recommendation] quencyof repositioning will be influenced byvariables 2.When a double-layer air-cell mattress overlay is concerning the individual and support surface in used, repositioning maybe performed at an interval of useU5). The WOCN guidelines6) also recommend the 4 hours or less. determination of the interval of repositioning after [Rating]C1 sufficient evaluation of the bodypressure dispersion [ Analysis ]There are two new systematic mattress. reviews1,2) and one new RCT3) concerning reposition- For these reasons, the recommendation level was ing for the prevention of pressure ulcers. In one rated as B for(1)and C1 for(2). systematic review, comparison of repositioning every References 4 hours and every6 hours on a 15-cm thick visco- elastic foam mattress showed no significant difference 1)Gillespie BM, Chaboyer WP, Mcinnes E, et al : with a relative risk of the occurrence of pressure ulcer Repositioning for pressure ulcer prevention in adults, (categories 1-4)of 0.73(95% CI : 0.53-1.02)1). The Cochrane Database Syst Rev, 2014.(LevelⅠ) other systematic review reported that no difference 2)Chou R, Dana T, Bougatsos C, et al : Pressure ulcer was observed in the incidence of pressure ulcers risk assessment and prevention : A systematic when the interval of rotation between the 30°lateral comparative effectiveness review, Ann Intern Med, recumbent position and 30°Fowler position on a 7cm 159(1):28-38, 2013.(LevelⅠ) thick visco-elastic foam mattress was changed( 2 3)Bergstrom N, Horn SD, Rapp MP, et al : Turning for hours in the lateral recumbent position and 4 hours in ulcer reduction : A multisite randomized clinical trial Fowler position in the studygroup, 4 hours in each in nursing homes. J Am Geriatr Soc, 61(10):1705- position in the control group)2). In this study, however, 1713, 2013.(LevelⅡ) it must be considered that grade 1 was excluded from 4)Nakashima F, Toyoda T : Evaluation of pressure ulcer pressure ulcers2). Also, in the RCT, the results of development in patients who underwent positional repositioning every2, 3, and 4 hours on a high-density changes at intervals of 2 hours or more. Jpn J P U, 5 foam mattress were compared in 942 elderlynursing (1):37-41, 2003.(LevelⅣ)(Japanese, English ab- home residents, but the incidence of pressure ulcer stract) did not differ significantly(p=0.680)3). The subject 5)National Pressure Ulcer AdvisoryPanel and Euro- enrolled in these studies, however, differ in respect to pean Pressure Ulcer AdvisoryPanel : Prevention and

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treatment of pressure ulcers, clinical practice guide- 2)Chou R, Dana T, Bougatsos C, et al : Pressure ulcer line, National Pressure Ulcer AdvisoryPanel, risk assessment and prevention:Asystematic Washington DC, 2009. comparative effectiveness review, Ann Intern Med, 6)Wound, Ostmyand Continence Nurses Society: 159(1):28-38, 2013.(LevelⅠ) Guideline for prevention and management of press- ure ulcers. WOCN clinical practice guidelines no. 2 CQ 9. 4:How can patients in intensive care be Glenview, IL, 2010. repositioned in order to prevent pressure ulcer formation? CQ 9. 3:When repositioning bed bound patients, [ Recommendation ]The patient maybe reposi- what positions should be undertaken to avoid tioned in an electric rolling hospital bed. pressure ulcer formation? [Rating]C1 [ Recommendation ]Both the 30-degree and 90- [Analysis]Patients in intensive care with unstable degree lateral recumbent positions are recommended. vital signs pose a greater difficultyto the attending [Rating]B nurse who must periodicallyreposition the patient. A [ Analysis ]There are two systematic reviews historical cohort study1) conducted at a cardiac concerning repositioning for the prevention of press- treatment center examined the rate of pressure ulcer ure ulcers1, 2)When alternation of 30-degree left and development among cardiac patients during the right recumbent positions every3 hours and alterna- period in which theywere repositioned manuallyat 2 tion of 90-degree lateral recumbent and prone hour intervals bynursing staff compared to the period positions every6 or 3 hours were compared, the in which theywere repositioned in an electric rolling results were reported not to have differed significant- hospital bed. The results indicated that the rate of lywith a relative risk of the occurrence of pressure pressure ulcer development in the period during ulcers(categories 1-4)of 0.62(95%CI : 0.10-3.97)1). which the electric rolling hospital bed was used was Also, when alternation of 30-degree lateral recumbent significantlylower( p<0. 001 ). Because the electric positions every3 hours and 90-degree lateral recum- rolling hospital bed featured in the studywere bent positions every6 hours were compared in equipped with various functions, it is difficult to subjects at a low risk for pressure ulcer, the 30- establish the efficacyof anysingle one of these degree recumbent position was reported to be more functions for the prevention of pressure ulcers. In effective with a relative risk of 0.27(95%CI : 0.08- Japan, due to cost considerations and the difficultyof 0.93)2). Since there are two factors of intervention, i.e., technical maintenance, few health care institutions are position and interval of repositioning, it is difficult to equipped with high-tech rolling hospital beds. For the conclude that either factor is significant. above reasons, the use of electric rolling hospital bed The 30-degree tilted side-lying position requires is assigned the recommendation rating of C1. patients to support their bodyweight with their References gluteal muscles. However, due to the decline in nutritional health as well as muscular atrophy 1)Gregor S, Kerstin F, Enrico Z, et al : Kinetic therapy resulting from inactivity, bed bound patients in Japan reduces complications and shortens hospital stayin tend to show more prominent bonyprominences in patients with cardiac shock, a retrospective analysis. the buttock region. For this reason, the bodyposition Eur J Cardiovasc Nurs, 6( 1 ):40-45, 2007.( Level of the patient should be chosen in accordance with the Ⅳ) wishes of the patient or the physical stature of the patient, rather than adhering strictlyto the 30-degree CQ 9. 5:What positioning is recommended for tilted side-lying position ; recommendation rating B. patients with articular contracture? [Recommendation]Positioning maybe performed References using bodypressure dispersion devices/cushions. 1)Gillespie BM, Chaboyer WP, Mcinnes E, et al : [Rating]C1 Repositioning for pressure ulcer prevention in adults, [Analysis]Thereis one studyin 5 elderlypatients Cochrane Database Syst Rev, 2014.(Level Ⅰ) with articular contracture in a recuperation type

―G−74― 褥瘡会誌(2016) ― 529 ― hospital in Japan1). As a result of positioning using area of the wounds was statisticallysignificant, at 0.16 pillows appropriate for the severityof articular for thekchanged,land 1.36 for theknon-changed,l contracture was performed for 1 year, an increase in groups( p=0. 02 ). In a separate study2) measuring the range of joint motion and an improvement in the pressure on healthyskin and the thickened tissue of bodypressure value were reported to have been the wound peripheryin patients in a 30-degree tilted achieved. Also, the NPUAP/EPUAP guidelines2) and side-lying position and 30-degree head-of-bed elevated WOCN guidelines3) recommend the use of cushions position demonstrated significantlyhigher maximal and pillows, minimum positioning, decompression, and pressure(p=0.01, p=0.05)as well as significantly elimination of slipping and friction in patients difficult higher average pressure( p=0. 01, p=0. 03 )on the to reposition. Since the physique of elderly people and thickened tissue. Both above-mentioned studies ex- bodypressure dispersion devices in Japan are amined pressure ulcers among bed bound elderly considered to differ, the recommendation level was patients. rated as C1. The so-called 30-degree rule was become wide- spread as a means of preventing pressure ulcers, and References has also been applied to the management of existing 1)Doken Y, Yasuda T, Umemura T, et al : Effect of pressure ulcers. However, it should be borne in mind positioning on bedridden elderlypeople with joint that this rule mayhave the effect of prolonging contracture. Jpn JPU, 15(4):476-483, 2013.(Level recoveryif applied in all cases regardless of the Ⅴ) physical stature of the patient. We recommend that a 2)National Pressure Ulcer AdvisoryPanel and Euro- bodyposition most suitable to the physicalstature and pean Pressure Ulcer AdvisoryPanel : Prevention and wound condition of the patient be chosen, rather than treatment of pressure ulcers : clinical practice guide- adhering strictlyto the 30-degree rule. On the basis of line. National Pressure Ulcer AdvisoryPanel, these considerations, we have assigned these evi- Washington DC, 2009. dence sources a recommendation rating of C1. 3)Wound, Ostmyand Continence Nurses Society: References Guideline for prevention and management of press- ure ulcers. WOCN clinical practice guidelines no. 2 1)Kitagawa A, Konya C, Omote S, et al : Effects of Glenview, IL, 2010. changing bodyposition on pressure ulcer morphology and blood circulation. JpnJPU,5(3):494-502, 2003. CQ 9. 6:What positions should be undertaken to (LevelⅢ)(Japanese, English abstract) promote healing in patients with pressure ulcers in 2)Okuwa M, Sugama J, Sanada H, et al : Measuring the the gluteal region? pressure applied to the skin surrounding pressure [ Recommendation ]Anyposition besides the 30- ulcers while patients are nursed in the 30°position. J degree tilted side-lying position or head-of-bed ele- Tissue Viability, 15(1):3-8, 2005.(LevelⅢ) vated position maybe undertaken. [Rating]C1 CQ 9.7:What kind of repositioning is effective for [ Analysis ]Two non-randomized self-controlled the prevention of pressure ulcers in patients with studies conducted in Japan have addressed the severe pressure ulcers that need intensive care? question of which bodypositions are best for patients [Recommendation]Basically, repositioning at least with pressure ulcers in the gluteal region. One study1) every2 hours maybe performed. compared the shape of the wounds after a period in [Rating]C1 30- and 90-degree side-lying positions and found that a [Analysis]There is one prospective cohort study total of 5 wounds demonstrated a change in shape, in a surgical intensive care unit( SICU )of a while 4 did not(changes in cross-sectional area of the university1). This studyconducted in 507 patients wound in thekchangedlgroup ; 72.3 : in theknon- reported that intervention byrepositioning every2 changedlgroup ; 8.2, p=0.04). Similar results were hours markedlyreduced pressure ulcers( p<0.0001) found with the 30-degree head-of-bed elevated posi- and suggested that stageⅠ and Ⅱ pressure ulcers tion group. The ratio of change in the cross-sectional can be prevented byaggressive intervention bya

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special staff assigned to turning and repositioning in 2)ReddyM, Gill SS, Rochon PA : Preventing pressure hemodynamically stable SICU patients1). In critical ulcers, a systematic review. JAMA, 296( 8 ):974- situations, sufficient repositioning is often difficult due 984, 2006.(LevelⅠ) to unstable hemodynamics. In this study, the mean 3)Whittemore R : Pressure-reduction support surfaces : Braden score was reported to be 16.5 before interven- A review of the literature. J Wound Ostomy tion and 13. 4( p=0. 04 )after intervention, but in- Continence Nurs, 25(1):6-25, 1998.(LevelⅠ) formation concerning the general condition such as 4)Nicosia G : The effect of pressure-relieving surfaces the APACHⅡ score and SOFA score is lacking. Care on the prevention of heel ulcers in a varietyof conditions such as the mattress used and reposition- settings : a meta-analysis. Int Wound J, 4(3):197- ing method( such as the angle )are considered to 207, 2007.(LevelⅠ) differ from those in Japan. Therefore, the recom- 5)McInnes E, Jammali-Blasi A, Bell-Syer SE, et al : mendation level was rated as C1. Support surfaces for pressure ulcer prevention. Cochrane Database Syst Rev,(4):CD 001735, 2011. References (LevelⅠ) 1)Still MD, Cross LC, Dunlap M, et al : The turn team : a 6)McInnes E, Jammali-Blasi A, Bell-Syer S, et al : novel strategyfor reducing pressure ulcers in the Preventing pressure ulcers-Are pressure- surgical intensive care unit. J Am Coll Surg, 216(3): redistributing support surfaces effective? A Cochrane 373-379, 2013.(LevelⅣ) systematic review and meta-analysis. Int J Nurs Stud, 49(3):345-359, 2012.(LevelⅠ) CQ 10 Support surfaces 7)Chou R, Dana T, Bougatsos C, et al : Pressure ulcer CQ 10.1:Should support surfaces be used to lower risk assessment and prevention : a systematic compa- the incidence of pressure ulcers? rative effectiveness review. Ann Intern Med, 159 [ Recommendation ]Use of support surfaces is (1):28-38, 2013.(LevelⅠ) stronglyrecommended in order to lower the inci- 8)Colin D, Rochet JM, Ribinik P, et al : What is the best dence of pressure ulcers. support surface in prevention and treatment, as of [Rating]A 2012, for a patient at risk and/or suffering from [Analysis]There are eight systematic reviews and pressure ulcer sore? Developing French guidelines meta-analyses which compare the use of standard for clinical practice. Ann Phys Rehabil Med, 55(7): hospital mattresses with other types of support 466-481, 2012.(LevelⅠ) surface1−8). All of these studies found that support 9)National Pressure Ulcer AdvisoryPanel and Euro- surfaces are significantlysuperior to standard hospital pean Pressure Ulcer AdvisoryPanel : Prevention and mattresses in preventing pressure ulcers. On the treatment of pressure ulcers : clinical practice guide- basis of this evidence, the use of support surfaces has line. National Pressure Ulcer AdvisoryPanel, been assigned a recommendation rating of A. Washington DC, 2009. Furthermore, the NPUAP/EPUAP guidelines9) state, TDo not base the selection of support surfaces solely CQ 10.2:Which support surface is recommended on the perceived level of risk for pressure ulcer for completelyimmobile patients? development or the category/stage of any existing [Recommendation] pressure ulcersUand,TChoose a support surface that 1.Recommend using an alternating-pressure air is compatible with the care setting" underscoring the mattress overlay/replacement. need to consider pressure ulcer risk, patientsl [Rating]B preferences, and care settings when choosing a [Recommendation] support surface. 2.Consider using a foam mattress replacement. [Rating]C1 References [ Analysis ]The NPUAP/EPUAP guidelines en- 1)Cullum N : Support surface for pressure ulcer dorse the use of alternating pressure air mattresses prevention. EBM reviews Cochrane Database Syst overlays/replacement for patients who cannot be Rev, 3 : CD001735, 2004.(LevelⅠ) repositioned frequently, adding that this method is

―G−76― 褥瘡会誌(2016) ― 531 ― endorsed bythe highest evidence rating 1). Two efficacyof alternating-pressure large-cell ripple randomized controlled studies which examined the mattresses1, 2), air-filled mattress overlays3), visco- incidence of pressure ulcer development among elastic foam mattresses4, 6), and convoluted foam completelyimmobile patients found that, although mattresses5) and found that alternating-pressure foam mattress replacements were more effective than large-cell ripple mattresses and visco-elastic foam foam mattress overlay, the incidence of pressure mattresses showed no difference in their efficacyin ulcers was still high at 25%, indicating generallypoor preventing pressure ulcers, citing differences in efficacy2). Berthe et al. have also reported that no support surface types and the condition of the significant difference was found between standard individual patients as the reason. A comparison of air- hospital mattresses and foam mattress replacements filled mattress overlayand other control mattresses in the incidence of pressure ulcer development3).On showed no significant difference in efficacy. On the the basis of these data, the use of foam mattress other hand, convoluted foam mattresses showed replacements earns a recommendation rating of C1. significantlyhigher efficacythan other control mat- tresses in preventing pressure ulcers. Nonetheless, References the pressure ulcer development incidence was 26.6%, 1)National Pressure Ulcer AdvisoryPanel and Eu- indicating that convoluted foam mattresses were ropean Pressure Ulcer AdvisoryPanel : Prevention generallyineffective at prevention and could not be and treatment of pressure ulcers : clinical practice recommended for use ; recommendation rating C1. In guideline. National Pressure Ulcer AdvisoryPanel, a randomized controlled trial involving Japanese Washington DC, 2009. subjects, double-layer air-cell mattress, single-layer 2)Vyhidal SK, Moxness D, Bosak KS, et al : Mattress air-cell mattress overlay, and standard hospital replacement or foam overlay? A prospective study on mattress were associated with a pressure ulcer the incidence of pressure ulcers. Appl Nurs Res, 10 development incidence of 3. 4%, 19. 2%, and 37. 0%, (3):111-120, 1997.(LevelⅡ) respectively, with double-layer air-cell mattress show- 3)Berthe JV, Bustillo A, Melot C, et al : Does a foamy- ing a significantlylower incidence than the others block mattress system prevent pressure sores? A (p<0.01)7). The same studyfound that the double- prospective randomized clinical trial in 1729 patients. layer air-cell mattress was similarly effective in a 45- Acta Chir Belg, 107(2):155-161, 2007.(LevelⅡ) degree head-of-bed elevated position. On the basis of these results, the use of the double-layered air-cell CQ 10.3:Which support surface is recommended mattress has been assigned a recommendation rating for prevention of pressure ulcers in elderlyindi- of B. viduals? For elderlypatients, the risk of pressure ulcers, [Recommendation] especiallyin areas with bonyprominences, and the 1.Recommend using a double-layer air-cell mat- particular care setting should also be considered when tress. choosing the most appropriate support surfaces. [Rating]B References [Recommendation] 2.An alternating-pressure air mattress overlay/ 1)Bliss MR : Preventing pressure sores in elderly replacement, air-filled mattress overlay, or foam patients : a comparison of seven mattress overlays. mattress mayalso be used. Age Ageing, 24(4):297-302, 1995.(LevelⅡ) [Rating]C1 2)Exton-Smith AN, Overstall PW, Wedgwood J, et al : [Analysis]Six randomized controlled studies pub- Use ofkair wave systemlto prevent pressure sores in lished outside Japan1-6), and one randomized controlled hospital. Lancet, 1( 8284 ):1288-1290, 1982.( Level studypublished in Japan 7), have examined the Ⅱ) relationship between various types of support sur- 3)Lazzara DJ, Buschmann MT : Prevention of pressure faces and the incidence of pressure ulcer development ulcers in elderlynursing home residents- : Are special among elderlypatients. support surfaces the answer?. Decubitus, 4(4):42- The studies published outside Japan examined the 48, 1991.(LevelⅡ)

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4)Russell LJ, Reynolds TM, Park C, et al : Randomized here. A number of controlled trials examining the clinical trial comparing 2 support surfaces : Results of incidence of pressure ulcers among Japanese subjects the prevention of pressure ulcers study. Adv Skin endorsed the use of alternating-pressure air mattress Wound Care, 16(6):317-327, 2003.(LevelⅡ) overlays as an effective means of lowering the 5)Kemp MG, Kopanke D, Tordecilla L, et al : The role of incidence of pressure ulcers7−9). Subsequently, a support surfaces and patient attributes in preventing clinical controlled trial compared the efficacyof pressure ulcers in elderlypatients. Res Nurs Health, alternating-pressure air mattress overlays, foam 16(2):89-96, 1993.(LevelⅡ) mattress overlays/ replacements and control mattres- 6)Gunningberg L, Lindholm C, Carlsson M, et al : Effect ses found that low air pressure mattresses were of visco-elastic foam mattresses on the development associated with a significantlylower rate of pressure of pressure ulcers in patients with hip fractures. J ulcer development(6%)than the control mattresses Wound Care, 9(10):455-460, 2000.(LevelⅡ) ( 28% ; p<0. 05 )7). On the basis of the evidence 7)Sanada H, Sugama J, Matsui Y, et al : Randomized presented above, these items have been assigned the controlled trial to evaluate a new double-layer air-cell recommendation rating of B. overlayfor elderlypatients requiring head elevation. Owing to advances in medical treatments, the J Tissue Viability, 13(3):112-121, 2003.(LevelⅡ) severityof the condition of patients admitted into the ICU and CCU has been increasing yearly along with CQ 10. 4:Which support surfaces are recom- the risk of pressure ulcer development. Accordingly, mended for prevention of pressure ulcers in intensive differences in care settings should be among the care patients? issues considered when selecting an appropriate [Recommendation] support surface. 1.Recommend using a low air pressure mattress. References [Rating]B [Recommendation] 1)Inmann KJ, Sibbald WJ, Rutledge FS, et al : Clinical 2.A low-air-loss bed, an alternating-pressure air utilityand cost-effectiveness of an air suspension bed mattress overlay, or an air-filled mattress replacement in the prevention of pressure ulcers. JAMA, 269 mayalso be considered. (9):1139-1143, 1993.(LevelⅡ) [Rating]C1 2)Theaker C, Kuper M, Soni N : Pressure ulcer [Analysis]There are five randomized controlled prevention in intensive care- a randomized control trials conducted outside Japan1−5), and four rando- trial of two pressure reliving devices. Anaesthesia, 60 mized controlled trials conducted within Japan (4):395-399, 2005.(LevelⅡ) examining the incidence of pressure ulcer among 3)Gebhardt KS, Bliss MR, Winwright PL, et al : patients admitted to the ICU or CCU6−9). Pressure-relieving supports in an ICU. J Wound Care, The studies conducted outside Japan examined the 5(3):116-121, 1996.(LevelⅡ) efficacyof low air-loss beds, alternating-pressure air 4)Sideranko S, Quinn A, Burns K, et al : Effects of mattress overlays, air-filled mattress overlays, water position and mattress overlayon sacral and heel mattresses, and air-filled mattress replacement in pressure in a clinical population. Res Nurs Health, 15 pressure ulcer prevention. The efficacyof low air-loss (4):245-251, 1992.(LevelⅡ) beds varied according to study1, 2) while air-filled 5)Takala J, Varmavuo S, Soppi E : Prevention of mattress overlays and water mattresses showed no pressure sores in acute respiratoryfailur e : a rando- significant difference when compared with other mized controlled trial. Clin Intensive Care, 7 : 228- control mattresses4). Although the air-filled mattress 235, 1996.(LevelⅡ) replacements were associated with a significantly 6)Fujioka A, Taneike M, Tanaka T, et al : Comparison of lower incidence of pressure ulcer development than two support surfaces from the point of the incidence the controls5), these results could not be corroborated of pressure ulcers and QOL of ICU patients. Jpn J byanystudies done in Japan 6). On the basis of the Nurs Soc : Adult Nursing I, 149-151, 1998.(LevelⅡ) evidence presented above, the recommendation (Japanese) rating of C1 has been assigned to the items discussed 7)Fujikawa Y, Terashi H, Sanada H : The assessment of

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low air pressure mattress for ICU Patients ; Incidence but failed to mention which support surfaces were of pressure ulcers and total cost. JpnJPU,3(1):44- most effective in achieving this result. 49, 2001.(LevelⅡ)(Japanese, English abstract) The studies published outside Japan were chiefly 8)Sugama J, Sanada H, Taneike M, et al : Differences in concerned with assessing the efficacyof gel or visco- the pressure distribution between static and alternat- elastic pad, alternating-pressure air mattress over- ing air mattresses. EmergencyNursing, 8(8):42- lays/replacement, bead bed system, and thermoactive 47, 1995.(LevelⅡ)(Japanese) viscoelastic foam overlay. The gel or visco-elastic pad 9)Sugama J, Sanada H, Taneike M, et al : Prevention of were associated with a significantlylower incidence of pressure sores for patients in intensive care unit pressure ulcer development than the control −Incidence of pressure sores using two types of mattresses5, 6). The results of using the alternating- mattress−. ICU and CCU, 19( 2 ):147-152, 1995. pressure air mattress overlays/replacement during (LevelⅡ)(Japanese) surgery, however, varied according to study and no clear conclusion could be reached regarding its CQ 10.5:Which tools, including support surfaces, efficacyin preventing pressure ulcers 7, 8). Although a are effective in preventing the development of significantlylower incidence of pressure ulcer occurr- pressure ulcers during perioperative periods? ence(15.6%)was associated with the use of the bead [Recommendation] bed system than with the controls, the bead bed 1.Support surfaces on the operating table are system cannot be considered as an effect means of stronglyrecommended for patients at risk of develop- reducing pressure ulcer development due to the high ing pressure ulcers. rate of pressure ulcer occurrence9). Fechtinger et al. [Rating]A have reported that there was no significant difference [Recommendation] in efficacybetween thermoactive viscoelastic foam 2.In addition to using support surfaces, visco- overlayand the control group 10). No randomized elastic pads or gel applied to the heel area, cubital controlled studies examining these support surfaces region, and other areas with bonyprominences is have been conducted in Japan. On the basis of these recommended during operations. data, the use of gel or visco-elastic pad has been given [Rating]B a recommendation rating of B, while the other types of [Recommendation] support surface have been assigned a rating of C1. 3.During and after operations, an alternating- The use of this evidence in Japan should be pressure air mattress overlays/replacement may be preceded bya careful consideration of the surgical used. procedure involved, the surgical environment, and [Rating]C1 risk to the patient. The surgical procedures discussed [Recommendation] in the above-mentioned studies involved maintaining 4.The bead bed system may be used during the lithotomyposition or supine position for three surgeryfor patients undergoing surgeryto repair continuous hours in general, vascular, gynecological, femoral-neck fracture. cardiac, or femoral surgical procedures for treating [Rating]C1 femoral neck fractures. [Recommendation] References 5.Thermoactive viscoelastic foam overlaymaybe used for patients who will undergo cardiac surgery. 1)Cullum N : Support surface for pressure ulcer [Rating]C1 prevention. EBM reviews Cochrane Database Syst [ Analysis ]There are one systematic review1) Rev,3:CD001735, 2004.(LevelⅠ) three meta-analyses2−4)and six randomized controlled 2)McInnes E, Jammali-Blasi A, Bell-Syer SE, et al : trials5−10) which compare pressure ulcer development Support surfaces for pressure ulcer prevention. incidence among perioperative patients. Cochrane Database Syst Rev,(4):CD 001735, 2011. The systematic reviews reported that the use of (LevelⅠ) support surfaces on the operating table had a positive 3)Huang HY, Chen HL, Xu XJ : Pressure-redistribution effect on lowering the incidence of pressure ulcers, surfaces for prevention of surgery-related pressure

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ulcers : a meta-analysis. Ostomy Wound Manage, 59 when using conventional bedding. The same subjects (4):36-48, 2013.(LevelⅠ) also reported experiencing verygood qualityof sleep 4)Colin D, Rochet JM, Ribinik P, et al : What is the best (p=0.024). Furthermore, one in 17 subjects developed support surface in prevention and treatment, as of pressure ulcers in the four-week period during which 2012, for a patient at risk and/or suffering from the automatic turning air mattress was used. A self- pressure ulcer sore? Developing French guidelines controlled trial conducted in Japan reported that the for clinical practice. Ann Phys Rehabil Med, 55(7): caregiverls burden was lessened and no pressure 466-481, 2012.(LevelⅠ) ulcers reported during a two-week period in which 5)Schultz A, Bien M, Dumond K, et al : Etiologyand this mattress was used2). incidence of pressure ulcers in surgical patients. The automatic turning air mattress maybe used in AORN J, 70(3):434-449, 1999.(LevelⅡ) order to facilitate the activityof caregivers in a home 6)Nixon J, McElvennyD, Mason S, et a l : A sequential care setting and to improve the patientls qualityof randomized controlled trial comparing a dryvisco- sleep, but the basic purpose of this device is to assist elastic polymer pad and standard operating table the work of the caregiver. The caregiver still needs to mattress in the prevention of post-operative pressure ensure that the patientls bodyis repositioned on a ulcers. Int J Nurs Stud, 35(4):193-203, 1998.(Level regular basis. Ⅱ) References 7)Aronovitch SA, Wilber M, Slezak S, et al : A comparative studyof an alternating air mattress for 1)Melland HI, Langemo D, Hanson D, et al : Clinical prevention of pressure ulcers in surgical patients. evaluation of an automated turning bed. Orthop Nurs, OstomyWound Manage, 45(3):34-44, 1999.(Level 18(4):65-70, 1999.(LevelⅢ) Ⅱ) 2)Futamura M, Sugama J, Sanada H, et al : A clinical 8)Russel LJ, Lichtenstein SL : Randomized controlled evaluation of automatic turning function of column- trial to determine the safetyand efficacyof a multi- type air-cell mattress-Effect on pressure distribution cell pulsating dynamic mattress system in the and caregiverls burden in home cared elderly-. Jpn J prevention of pressure ulcers in patients undergoing Acad Gerontol Nurs, 10(2):62-69, 2006.(LevelⅢ) cardiovascular surgery. Ostomy Wound Manage, 46 (Japanese) (2):46-55, 2000.(LevelⅡ) 9)Goldstone LA, Norris M, OlReillyM, et a l : A clinical CQ 10. 7:Which support surfaces provide the trial of a bead bed system for the prevention of greatest comfort both while awake and sleeping? pressure sores in elderlyorthopaedic patients. J Adv [Recommendation] Nurs, 7(6):545-548, 1982.(LevelⅡ) 1.Using an alternating-pressure air mattress 10)Fechtinger J, de Bie R, Dassen T, et al : A 4-cm replacement is recommended. thermoactive viscoelastic foam pad on the operating [Rating]B room table to prevent pressure ulcer during cardiac [Recommendation] surgery. J Clin Nurs, 15(2):162-167, 2006.(Level 2.The use of a double-layer air-cell mattress with a Ⅱ) detachable upper layer is recommended for patients after surgeryof the heart/great vessels. CQ 10.6:Which support surfaces can be used to [Rating]B facilitate care for convalescent patients in a home- [Recommendation] care setting? 3.For terminallyill patients, an alternating- [Recommendation]An automatic turning air mat- pressure air mattress with automatic adjustment to tress maybe used. the patient's weight and position maybe considered. [Rating]C1 [Rating]C1 [Analysis]In one self-controlled trial by Melland et [ Analysis ]One systematic review1), two rando- al.1), patients in a home-care setting and a long-term mized controlled trials2, 3)conducted outside Japan and care facilityreported no difference in comfort levels one randomized controlled trial4) conducted in Japan when using an automatic turning air mattress than have examined the qualityof sleep and comfort levels

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experienced bypatients who were used an with the use of dual-fit-air-cell mattresses : A rando- alternating-pressure air mattress replacement. The mized controlled trial for postoperative patients with systematic review found that the comfort levels cardiovascular surgery. Jpn JPU, 13( 2 ):142-149, reported bythe patients were significantlyhigher for 2011.(LevelⅡ) the alternating-pressure air mattress overlays/repl- acement than for the control group. Furthermore, the CQ 10.8:What precautions should be taken when two- and four-cell types were considered more using foam mattresses? comfortable1). In addition, 18. 9% of patients com- [ Recommendation ]Monitor the deterioration of plained about the alternating-pressure air mattress the foam due to fatigue. replacement while 23. 3% complained about the [Rating]C1 alternating-pressure air mattress overlay, indicating a [Analysis]Foam mattresses will degrade with the significantlylower number of complaints for the passage of time. One of the causes of the degradation former( p<0. 05 )2). When the comfortableness was of qualityis fatigue. Fatigue is seen when distortions compare between the double-layer air-cell mattress in the contours of the mattress remain even after the with a detachable upper layer, which has a structure weight or source of pressure has been removed. Two allowing the cells to fit the body, and the conventional analytical epidemiological studies have examined the double-layer air-cell mattress in Japanese patients problem of fatigue in urethane foam mattresses1, 2). after surgeryof the heart/great vessel, the stabilityin These studies found that 66 urethane foam mattres- the sitting position and perceived compression of the ses 5-10 years after their purchase had compressed an back were rated significantlyhigher in the former average of 10. 7±6. 0 mm( range 0-30 mm )from (p<0.000-0.01)4). Grindleyet al. surveyedterminal fatigue. Use of urethane foam mattresses which had patients about their preferences and found that 62.5% compressed an average of 11 mm as a result of fatigue preferred the alternating-pressure air mattress with significantlyincreased interface pressure values automatic adjustment to the patientls weight and compared with new mattresses(p<0.05)1). Further, position, 12.5% preferred the alternating-pressure air the studyexamined the degree of fatigue according to mattress overlay, and 25.0% preferred the standard contact points on the bodyincluding the buttocks, mattress(p<0.05)3). knees, shoulder joints, head, and heel, found that When choosing a mattress, consider the patientsl fatigue was most visible in the area of the mattress in preferences as well as pressure ulcer development direct contact with the buttocks(p<0.05)2). risk and pressure ulcer stage. On the basis of these data, urethane mattresses should be checked periodicallyfor signs of fatigue, References especiallyin the areas that come into frequent or 1)Vanderwee K, Grypdonck M, Defloor T : Alternating prolonged contact with the buttocks. pressure air mattresses as prevention for pressure References ulcers : a literature review. Int J Nurs Stud, 45(5): 784-801, 2008.(LevelⅠ) 1)Matsubara Y : Fatigue of foam mattress and interface 2)Nixon J, CrannyG, Iglesias C, et al : Randomized, pressure in healthyvolunteers. Nursing, 27(11):88- controlled trial of alternating pressure mattresses 93, 2007.(LevelⅣ)(Japanese) compared with alternating pressure overlays for the 2)Heule EJ, Goossens RH, Mugge R, et al : Using an prevention of pressure ulcers : PRESSURE(pressure indentation measurement device to assess foam relieving support surfaces)trial. BMJ, 332(7555): mattress quality. Ostomy Wound Manage, 53(11): 1413, 2006.(LevelⅡ) 56-62, 2007.(LevelⅠ)(LevelⅣ) 3)GrindleyA, Acre s J : Alternating pressure mattres- ses : comfort and qualityof sleep. Br J Nurs(Mark CQ 10. 9:Which support surfaces are recom- Allen Publishing ), 5(21):1303-1310, 1996.( Level mended for promoting healing in d1, d2, and D3-D5 Ⅱ) pressure ulcers? 4)Marutani A, Sugama J, Sanada H, et al : Evaluation of [Recommendation] pressure ulcer prevention and comfort associated 1.Use of an air-fluidized bed or low-air-loss bed is

―G−81― ― 536 ― stronglyrecommended to promote healing in D3-D5 One historical controlled trial15) and one non- pressure ulcers or pressure ulcers in multiple sites. controlled intervention study16) conducted in Japan [Rating]A using stageⅡ-Ⅳ pressure ulcer patients found that [Recommendation] use of double-layer air-cell mattresses was more 2.Use of an alternating-pressure air mattress with conducive to wound reduction than single-layer air- automatic adjustment for the patientls position and cell mattresses( p<0. 05 )15). The low air pressure weight, an alternating-pressure large-cell ripple mat- mattresses were also found to be more effective in tress, a double-layer air-cell mattress, or a low air wound reduction and skin regeneration than air-filled pressure mattress maybe considered to promote mattress overlays(p<0.05)16). healing in d2 or deeper pressure ulcers. On the basis of the data presented above, the use of [Rating]C1 air-fluidized beds and low-air-loss beds is strongly [Recommendation] recommended for patients diagnosed with stageⅢ or 3.Use of an air-filled mattress overlaymaybe Ⅳ, or D3-D5 pressure ulcers or with pressure ulcers in considered to promote healing in d1/2 pressure ulcers. multiple sites. However, in Japan the use of air- [Rating]C1 fluidized beds, low-air-loss beds and other equipment [Recommendation] of this nature is limited bycost and difficultyof 4.Use of an alternating-pressure air mattress with maintenance to veryfew health care institutions. automatic adjustment to the patientls weight and Furthermore, as with prevention measures, the choice position maybe considered after flap reconstruction of support surface involves not onlythe condition of for pressure ulcers. the patientls pressure ulcers but also a varietyof [Rating]C1 other factors, each of which requires due considera- [ Analysis ]The NPUAP/EPUAP1), WOCN2), and tion. the Wound Healing Society3) guidelines recommend References the use of special beds. The basis for their recom- mendation is found in two systematic reviews4, 5) and 1)National Pressure Ulcer AdvisoryPanel and Euro- five randomized controlled trials6−10)which found that pean Pressure Ulcer AdvisoryPanel : Prevention and the use of low-air-loss beds and air-fluidized beds was treatment of pressure ulcers : clinical practice guide- more effective for wound healing and contraction line. National Pressure Ulcer AdvisoryPanel, rates. The efficacyof alternating-pressure air mat- Washington DC, 2009. tress with automatic adjustment to the patientls 2)Wound Ostomyand Continence Nurses Society: position and weight function replacement was ex- Guide-line for prevention and management of press- amined in a randomized controlled trial involving ure ulcers. WOCN clinical practice guideline;no. 2, patients who had received flap surgeryfor pressure Glenview, IL, 2003. ulcers involving fascia, muscle and bone11)as well as in 3)WhitneyJ, Phillips L, Aslam R, et al : Guidelines for a randomized controlled trial involving stageⅡ-Ⅳ the treatment of pressure ulcers. Wound Repair pressure ulcer patients12). Neither studyfound a Regen, 14(6):663-679, 2006. significant difference in effect between the bed type in 4)Smith ME, Totten A, Hickam DH, et al : Pressure question and the controls. Bliss examined the efficacy ulcer treatment strategies : a systematic comparative of alternating-pressure large cell ripple mattresses in effectiveness review. Ann Intern Med, 159(1):39- a randomized controlled trial involving stageⅡ-Ⅳ 50, 2013.(LevelⅠ) pressure ulcers and found that theywere significantly 5)McInnes E, Dumville JC, Jammali-Blasi A, et al : more effective than the controls in promoting Support surfaces for treating pressure ulcers. healing13). On the other hand, Lazzara and Bushmann Cochrane Database Syst Rev,( 12 ):CD 009490, conducted a randomized controlled trial involving 2011.(Level Ⅰ) stateⅠ and Ⅱ pressure ulcer patients to examine the 6)DayA, Leonar d F : Seeking qualitycare for patients efficacyof air-filled mattress overlaysin promoting with pressure ulcers. Decubitus, 6(1):32-43, 1993. wound healing, and found no statisticallysignificant (LevelⅡ) difference with the control groups14). 7)Ferrell BA, Keeler E, Siu AL, et al : A randomized trial

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of low-air loss for treatment of pressure ulcers. [Rating]C1 JAMA, 269(4):494-497, 1993.(LevelⅡ) [Recommendation] 8)Branom R, Rappl LM :TConstant force technologyU 2.Education/training in anyor all of the following versus low-air-loss therapyin the treatment of maybe given : the etiologyof ulcers, risk factors, pressure ulcers. OstomyWound Manage, 47(9):38- staging, principles of wound healing, nutritional 46, 2001.(LevelⅡ) support, program of skincare and skin inspection, and 9)Munro BH, Brown L, Heitman BB : Pressure ulcers, management of incontinence. one bed or another?. Geriatr Nurs, 10(4):190-192, [Rating]C1 1989.(LevelⅡ) [Recommendation] 10)Allman RM, Walker JM, Hart MK, et al : Air-fluidized 3.Periodic telephone consultations with a health beds or conventional therapyfor pressure sores. A care professional maybe done. randomized trial. Ann Int Med, 107( 5 ):641-648, [Rating]C1 1987.(LevelⅡ) [Recommendation] 11)Finnegan MJ, Gazzerro L, Finnegan JO, et al : Com- 4.Periodic skin assessment bya medical expert paring the effectiveness of a specialized alternating using remote-controlled imaging is recommended. air pressure mattress replacement system and an air- [Rating]B fluidized integrated bed in the management of post- [Recommendation] operative flap patients : a randomized controlled pilot 5.Education byan e-learning systemled bythe study. J Tissue Viability, 17(1):2-9, 2008.(Level health care professional maybe given. Ⅱ) [Rating]C1 12)Evans D, Land L, GearyA, et a l : A clinical evaluation [Analysis]There are one randomized controlled of the Ninbus 3 alternating pressure mattress trials, one non-randomized controlled trial, one cohort replacement system. J Wound Care, 9(4):181-186, study, one pilot study, and numerous case reports 2000.(LevelⅡ) pertaining to patient education. 13)Bliss MR : Preventing pressure sores in elderly Instructions in repositioning including positioning, patients : a comparison of seven mattress overlays. posture in using the wheelchair, and maintaining Age Ageing, 24(4):297-302, 1995.(LevelⅡ) correct sitting posture can be carried out to prevent 14)Lazzara DJ, Buschmann MT : Prevention of pressure the development of pressure ulcers. Further, the ulcers in elderlynursing home residents : Are special measurement of pressure on various points of the support surfaces the answer?. Decubitus, 4(4):42- bodyin turn leads to a better understanding of 48, 1991.(LevelⅡ) prevention as well as risk assessment, as reported in a 15)Sato A, Sanada H, Sugama J, et al : The cost- number of published case studies1−3). The recom- effectiveness of double-layer air-cell mattress for mendation level was rated as C1. treating pressure ulcers. Jpn J PU, 8(2):140-147, The WOCN Clinical Practice Guidelines4) has a 2006.(LevelⅢ)(Japanese, English abstract) section on education on the topics including the 16)Sanada H, Sugama J, Inagaki M, et al : Evaluation of a etiologyof ulcers, risk factors, staging, principles of newly-developed overlaying low pressure air- wound healing, nutritional support, program of mattress. Memoirs Health Sci Med Kanazawa Univ, skincare and skin inspection, and management of 21 : 45-49, 1997.( LevelⅤ )( Japanese, English ab- incontinence ; however, these are based on expert stract) opinion. With regard to the efficacyof consultations with CQ 11 Patient education health care professionals, one randomized controlled CQ 11. 1:How can patients and their familyor trial has reported that knowledge of pressure ulcer caregivers be educated to prevent the development prevention among the consultation group was higher or recurrence of pressure ulcers? than among the control group as a result of monthly [Recommendation] telephone contact after discharge in addition to 1.Education/training in repositioning and using enhanced education given to the participants prior to support surfaces can be carried out. discharge from hospital5). However, the content of the

―G−83― ― 538 ― instruction was not specified nor was the statistical 2)Hori M, Kakuya K, Orikasa H, et al : Management of a significance documented. The recommendation level paraplegic patient who suffers from repeated ischial was rated as C1. pressure ulcers. Jpn J PU, 3( 3 ):351-354, 2001. Other studies include a RCT using a remote- (levelⅤ)(Japanese, English abstract) controlled interventional device, which is a dialogue- 3)Ogawa N, Tanaka H, Toyoda M, et al : Improving type vocal response system combining elements curative environment through mental relationship including educational intervention and screening6). -For a bedsore patient with spinal cord injury-. Jpn J Although in females of the intervention group alone, WOCN, 5(2):26-30, 2002.(LevelⅤ)(Japanese, the incidence of pressure ulcers was significantly English abstract) reduced, and the number of health care reports 4)Wound Ostomyand Continence Nurses Society: increased. A non-randomized controlled trial7) com- Guideline for Prevention and Management of Press- paring the efficacyof periodic intervention using ure Ulcers, 24, WOCN Society, IL, 2003. video images as an educational tool, periodic telephone 5)Garber SL, Rintala DH, Holmes SA, et al : A intervention, and telephone counseling as freely structured educational model to improve pressure chosen bythe patient, found that reports of pressure ulcer prevention knowledge in veterans with spinal ulcers were highest among the video group although cord dysfunction. J Rehabil Res Dev, 39( 5 ):575- the differences among the groups were not statistical- 588, 2002.(LevelⅡ) lysignificant. The larger number of reports among 6)Houlihan BV, Jette A, Friedman RH, et al : A pilot the video group is thought be due to the higher rate of studyof a telehealth intervention for persons with detection resulting from the increased opportunities spinal cord dysfunction. Spinal Cord, 51( 9 ):715- for visual contact with health care professionals. 720, 2013.(LevelⅡ) Further, the fact that pressure ulcers detected among 7)Phillips VL, Temkin A, Vesmarovich S, et al : Using the video group were generallyless advanced telehealth interventions to prevent pressure ulcers in suggests that this mode of education/consultation was newlyinjured spinal cord injurypatients post- effective for earlydetection as well. However, the discharge. Results from a pilot study. Int J Technol remote video and telephone consultations featured in Assess Health Care, 15( 4 ):749-755, 1999.( Level these two foreign studies are not covered bythe Ⅲ) National Health Insurance in Japan. On the other 8)Brace JA, Schubart JR : A prospective evaluation of a hand, the viabilityof these methods is being consi- pressure ulcer prevention and management e- dered within the context of home nursing care in learning program for adults with spinal cord injury. Japan. Therefore, the recommendation level was OstomyWound Management, 56( 8 ):40-50, 2010. rated as B. (LevelⅤ) According to one cohort study8) and one pilot- 9)SchubartJ:Ane-learning program to prevent study9), e-learning implemented as a form of visual pressure ulcers in adults with spinal cord injury: a educational method succeeded in raising awareness pre- and post- pilot test among rehabilitation patients about pressure ulcers among the participants, as following discharge to home. OstomyWound Manage- demonstrated bytest results. Although such methods ment, 58(10):38-49, 2012.(LevelⅣ) do not directlyaffect the rates of occurrence or healing of pressure ulcers among the participants, CQ 11. 2:How should patients/family/caregivers theyhave proved effective as educational tools. be educated/trained in the care of existing pressure Therefore, the recommendation level was rated as C1. ulcers? [Recommendation] References 1.Information concerning the procedure to con- 1)Sato M, Shimobatake Y, Nakahara K, et al : Case of tact appropriate medical center maybe provided in spinal cord injuryrecovered pressure ulcer of the event of abnormalities. hipbone. Leaving hospital adjustment for recurrence [Rating]C1 prevention. Jpn AdnⅡ, 36 : 390-391, 2005.(LevelⅤ) [Recommendation] (Japanese) 2.Education bymedical experts maybe per-

―G−84― 褥瘡会誌(2016) ― 539 ― formed using e-learning. [Recommendation] [Rating]C1 5.Assignment of wound ostomyand continence [ Analysis ]A search of the currently existing nurse maybe considered. sources underk education lfailed to produce any [Rating]C1 reports based on clinical trials. The WOCN Practice [Recommendation] Guideline1) recommends contacting a health care 6.Introduction of reimbursement system for professional in the event of anycomplications, based pressure ulcer high risk patient care maybe on expert opinion. The recommendation level was considered. rated as C1. [Rating]C1 Recently, also, there has been a pilot study that [Recommendation] showed an improvement in knowledge about pressure 7.Electronic charts including a pressure ulcer risk ulcer after e-learning about the prevention and assessment tool maybe considered. management of pressure ulcer2). While the cure rate of [Rating]C1 pressure ulcers is unknown, the recommendation [ Analysis ]Comfortls meta-analysis1) of nine stu- level was rated as C1, because the technique was dies found after a search using the keywords, suggested to be effective for education after the kBradenlandksupport surface,lexamines the choice development of pressure ulcer. of support surfaces based on risk assessment con- ducted with the Braden Scale at acute treatment References facilities and universityhospitals. Comfortls study 1)Wound, Ostmyand Continence Nurses Society: found that the odds ratio of pressure ulcer develop- Guideline for prevention and management of press- ment in the group using support surfaces chosen on ure ulcers. WOCN clinical practice guidelines no. 2 the basis of risk assessment using the Braden Scale Glenview, IL, 2010. was 0.335(95% CI=0.220-0.508). This report demons- 2)SchubartJ:Ane-learning program to prevent trates a high level of efficacyin using Braden Scale pressure ulcers in adults with spinal cord injury: a risk assessment as a basis for choosing a support pre- and post- pilot test among rehabilitation patients surface for pressure ulcer prevention, and is therefore following discharge to home. OstomyWound Manage- stronglyrecommended. ment, 58(10):38-49, 2012.(LevelⅣ) There is one systematic review that assessed the effectiveness of a comprehensive and multidisciplin- CQ 12 Outcome management arypressure ulcer prevention program in acute phase CQ 12.1:Which measures should be undertaken in and long-term care hospitals.2). According to this a hospital care setting to prevent pressure ulcers? review, decreases were reported in 16 of the 17 papers [Recommendation] that evaluated the morbidityrate and in 4 of the 5 1.Choice of support surface based on the Braden papers that evaluated the incidence after the use of Scale is stronglyrecommended. the comprehensive pressure ulcer prevention prog- [Rating]A ram in acute phase care hospitals. [Recommendation] A meta-analysis examining the effect of utilizing 2.Implementation of comprehensive programs clinical paths on the formation of pressure ulcers in and protocols maybe considered. post-operative femoral neck fracture patients3) found [Rating]B the odds ratio for pressure ulcer development to be 0. [Recommendation] 48( 95% CI=0. 30-0. 75 )in 2935 subjects across six 3.Choice of support surface based on the OH Scale comparative studies. An historical controlled studyby maybe considered. de Laat et al. involving 399 adult patients in an [Rating]C1 intensive care unit of an universityhospital(28 beds) [Recommendation] examined the efficacyof a care regimen for preven- 4.Deployment of a multidisciplinary wound care tion of pressure ulcer based on the Dutch AHCPR/ team maybe considered. EPUAP guidelines4). The three-month mark was [Rating]C1 established as a baseline, and changes in patientsl

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condition were monitored from months 3 to 6 and employing a wound ostomy and continence nurse may months 12 to15 after implementation of the protocol. have a significantlypositive effect on the prevention The results indicated a significant reduction in the of pressure ulcers. rate of pressure ulcer development( p=0. 04 ).In One prospective cohort studyinvolving 190 wound addition, there are a number of cohort studies which ostomyand continence nurses( 111 nurses who have examined the efficacyof comprehensive press- introduced the afore-mentioned reimbursement sys- ure ulcer prevention regimens. As can be seen, tem(see item 5 above), and 79 who did not)found measures utilizing clinical paths, guidelines, and that the estimated incidence of pressure ulcer comprehensive programs have proved to be effective development in reimbursement system-introduced in preventing pressure ulcer development. hospital was significantlylower than that in non- An historical controlled studybyTakagi et al. introduced hospitals(p=0.008)8). These results indi- evaluated the criteria for selecting support surfaces cate that the reimbursement system can produce a based on the OH scale, using as the experimental significant decrease in the incidence of pressure ulcer group, 445 patients, and as the control group, 354 development. patients, hospitalized in a general hospital with 198 There is one historical controlled trial that evalu- beds5). The results of the studyindicated that the rate ated the pressure ulcer preventing effect of the use of of pressure ulcer development in the experimental an electronic chart including a pressure ulcer risk group was significantlylower( p<0.05), thus demon- assessment tool in 29 hospitals in the state of strating the utilityof the algorithm based on the OH California9). The trial reported that the implementa- Scale for choosing appropriate support surfaces for tion rate of pressure ulcer risk assessment was pressure ulcer prevention. significantlyincreased( p=0.005), and the incidence A longitudinal studybyGranick et al. examined the of pressure ulcer was significantlyreduced( p=0.01), efficacyof prophylactictreatment administered to 690 bythe use of the electronic chart including a pressure patients at an universityhospital byan interdisciplin- ulcer risk assessment tool, physicianslorder entries, arywound care team 6). The results of the study and nursesldocuments. demonstrated that the prevalence of pressure ulcers References declined steadilyfrom the first, through the second and third years of intervention(p<0.05). A compari- 1)Comfort EH : Reducing pressure ulcer incidence son of the number of new cases of pressure ulcers in through Braden Scale risk assessment and support the first and third years shows a significant decline surface use. Adv Skin Wound Care, 21(7):330-334, (p<0.005). In addition, several cohort studies have 2008.(LevelⅠ) reported a decrease in the number of both existing 2)Niederhauser A, VanDeusen Lukas C, Parker V, et al : pressure ulcer cases and new cases following in- Comprehensive programs for preventing pressure tervention bya multidisciplinarywound care team ulcers : a review of the literature. Adv Skin Wound consisting of physicians, nurses, dietitians, occupation- Care, 25(4):167-188, 2012.(LevelⅠ) al therapists, pharmacologists, registered dieticians, 3)Neuman MD, Archan S, Karlawish JH, et al : The and administrative staff at general and acute phase relationship between short-term mortalityand qual- treatment facilities. These data demonstrate the ityof care for hip fractur e : a meta-analysis of clinical efficacyof multidisciplinarywound care team in pathways for hip fracture. J Am Geriatr Soc, 57 preventing pressure ulcers. (11):2046-2054, 2009.(LevelⅠ) An historical controlled studyconducted bySobue 4)de Laat EH, Pickkers P, Schoonhoven L, et al : Guide- et al. examined the prevalence of pressure ulcers in line implementation results in a decrease of pressure hospital before and after group training bya wound ulcer incidence in criticallyill patients. Crit Care Med, ostomyand continence nurse 7). The results of the 35(3):815-820, 2007.(LevelⅣ) studyindicated that the rate of pressure ulcer 5)Takaki Y, Toyohara T : Use of criteria for the development was significantlylower( p<0.05)three selection support surfaces and changes in the years after, compared to six months before, com- incidence of pressure ulcer. Jpn J PU, 10(1):39-43, mencement of training. These data suggest that 2008.(LevelⅣ)(Japanese, English abstract)

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6)Granick MS, McGowan E, Long CD : Outcome that the use of algorithms based on the Braden Scale assessment of an in-hospital cross-functional wound at long-term care facilities is effective for pressure care team. Plast Reconstr Surg, 101(5):1243-1247, ulcers prevention. 1998.(LevelⅣ) References 7)Sobue M, Tanahashi S, Hori S, et al : The effects of caring for pressure ulcers bythe skin care committee. 1)Lyder CH, Shannon R, Empleo-Frazier O, et al : A Jpn J PU, 7(1):43-52, 2005.(LevelⅣ)(Japanese, comprehensive program to prevent pressure ulcers English abstract) in long-term care : exploring costs and outcomes. 8)Sanada H, Mizokami Y, Minami Y, et al : The impact of OstomyWound Manage, 48(4):52-62, 2002.(Level reimbursement system for pressure ulcer high risk Ⅳ) patient care on the pressure ulcer incidence and 2)Sanada H, Sugama J, Sugimura S, et al : The medical cost. Jpn J WOCN, 11( 2 ):59-62, 2007. effectiveness of care algorithm for prevention of (LevelⅣ)(Japanese, English abstract) pressure ulcer in a long term care facility. Jpn J 9)Dowding DW, TurleyM, Garrid o T : The impact of an Nursing Society, elderly, 25 : 170-173, 1994.( Level electronic health record on nurse sensitive patient Ⅳ)(Japanese) outcomes : an interrupted time series analysis. J Am Med Inform Assoc, 19(4):615-20, 2012.(LevelⅣ) CQ 12. 3:Which measures are recommended to promote healing of pressure ulcers in a hospital care CQ 12. 2:Which measures are recommended for setting? pressure ulcer prevention in long-term care facilities? [Recommendation] [Recommendation] 1.Deployment of a multidisciplinary wound care 1.Implementation of comprehensive programs team maybe considered. and protocols maybe considered. [Rating]C1 [Rating]C1 [Recommendation] 2.Use of an algorithm incorporating the Braden 2.Introduction of reimbursement system for Scale to implement preventive care maybe consi- pressure ulcer high risk patient care maybe dered. considered. [Rating]C1 [Rating]C1 [Analysis]The efficacy of pressure ulcer predic- [Recommendation] tion based on the Braden Scale, prevention programs, 3.Assignment of wound ostomyand continence skin care regimens, nutritional supplementation, skin nurse maybe recommended. consultation with WOC nurses and similar compre- [Rating]C1 hensive care for pressure ulcers at two long-term care [ Analysis ]A longitudinal study conducted by facilities(facilityA, 150 beds ; facilityB, 110 beds) Ogawa et al. involving 48 patients with pressure have been examined in a longitudinal study1). The ulcers at a general ward and a nursing ward results indicated that there was a significant decrease examined the efficacyof a multidisciplinarywound in the rate of pressure ulcer development four months management team in pressure ulcer healing rate1). after commencement of the program( P=0. 02 ), The studyreported a significant improvement in the suggesting that the adoption of comprehensive DESIGN scores six months after the start of the programs and protocols at long-term care facilities is teamls activities as compared to scores obtained six effective in preventing pressure ulcer development. months prior to the commencement of their activities An historical controlled studyof the efficacyof a ( p<0. 05 ), stronglyindicating the positive effect of Braden Scale-based pressure ulcer prevention algor- such multidisciplinaryteams on wound healing. ithm employed at a special elderly care facility(120 There is also a retrospective cohort studythat beds)found a marked decrease in the prevalence of evaluated the usefulness of the involvement of pressure ulcer nine months after the implementation pharmacists in the pressure ulcer care team2). When 5 of the algorithm as compared to nine months prior to hospitals in which pharmacists authorized bythe implementation(P<0.01)2). This evidence suggests Japanese Societyof Pressure Ulcers were involved in

―G−87― ― 542 ― the pressure ulcer care team byparticipating a creation of committee. Jpn J PU, 7(2):184-189, activities such as ward rounds and 4 hospitals without 2005.(LevelⅣ)(Japanese, English abstract) involvement of pharmacists were compared, the total 2)Furuta K, Mizokami F, Miyagawa T, et al : Effects of score of DESIGN-R was significantlylower( p=0.013) pressure ulcer treatment teams including physicians, and showed significant decreases(p<0.001)in the pharmacists, and nurses on medical costs. J Jpn Soc hospitals with pharmacist involvement at weeks 2 and Healthc Adm, 50(3):199-207, 2013.(LevelⅣ) 3. In addition, the cost-effectiveness was reported to 3)Sanada H, Nakagami G, Mizokami Y, et al : Evaluating be significantlyhigher( p=0.001). effect of new incentive system for high-risk pressure A prospective cohort studyexamined the impact of ulcer patients on wound healing and cost- introducing reimbursement system for high risk effectiveness : A cohort study. Int J Nurs Stud, 47 patients on pressure ulcer healing at a total of 59 (3):279-286, 2010.(LevelⅣ) health care facilities, including advanced treatment 4)Takaki Y, Shirayama C, Masutomi T, et al : Practice facilities, regional central hospital, and general report of a WOC-certified expert nursels pressure hospitals3). The studyreported that the DESIGN ulcer care in a long team care unit. Jpn J WOCN, 6 scores for patients in facilities that introduced (2):20-24, 2003.(LevelⅤ)(Japanese, English ab- reimbursement system had decreased during three stract) weeks significantlymore compared to those patients in facilities that had no billable services(p=0.002). CQ 12. 4:Which measures are recommended to Further, multiple regression analysis using the promote healing of pressure ulcers in a long-term care decrease in the DESIGN score as a dependent variable facility? found a significant correlation between pressure ulcer [Recommendation] healing and the implementation of the afore- 1.Deployment of a multidisciplinary wound care mentioned care(p<0.001). This data suggests that team is recommended. the introduction of reimbursement system for high [Rating]B risk patient care has a positive impact on the healing [Recommendation] of pressure ulcer. 2.Implementation of comprehensive programs Two case reports examined the impact of care and protocols maybe considered. provided bywound ostomyand continence nurse at a [Rating]C1 nursing ward in a coloproctological facility4).Inone [Analysis]A randomized controlled trial involving case, pressure ulcer was improved after the assess- 44 nursing homes( intervention group, 21 ; control ment bya wound ostomyand continence nurse and group, 23)assessed the efficacyof a multifunctional change of the bodypressure dispersion mattress. The wound care team in promoting pressure ulcer healing second studyfailed to assess the effect of care and found that the intervention group showed a administered bywound ostomyand continence nurse higher healing rate than the control group(P=0.07) on cases of prolonged recoverycaused bycontamina- with a hazard ratio of 1. 73(P=0. 003 )1). This data tion of the wounds byurine. In the former, the indicate that the deployment of a multifunctional deployment of wound ostomy and continence nurse as wound care team at a long-term care facilityis likely one of the conditions stipulated in the introduction of to have a positive impact on the healing rates of reimbursement system for high risk patient care can pressure ulcer. However, it should be noted that only be seen as a major contributing factor in the success 80% of the enrolled patients suffered from pressure of these services3). Taken as a whole, these data ulcers, while 20% had leg ulcers. suggest that the care administered bywound ostomy A historical controlled studycompared healing time and continence nurse has a positive impact on the of pressure ulcers among patients at a long-term care healing of pressure ulcers. facility( 77 beds )who were either administered a care protocol based on guidelines or treated according References to conventional methods2). The subjects were divided 1)Ogawa R, Kikuchi M, Kato K, et al : Prevention effects into three groups based on three time frames : before and therapeutic outcomes of pressure ulcer based on intervention, immediatelyafter intervention, and

―G−88― 褥瘡会誌(2016) ― 543 ― three years after intervention. Using healing of health scores for those patients suffering from pressure ulcer in each group as the end-point, the pressure ulcers were significantlylower in compari- survival curve was assessed bythe Log rank test. The son with those of who did not suffer from pressure results of this assessment found a significant differ- ulcers(p=0.001)3). SF36, Craig Handicap Assessment ence between each of the three groups in terms of the and Reporting Technique(CHART), Life Situation duration required for pressure ulcer healing( Log Questionnaire-Revised( LSQ-R ), and Powers QOL rank=9. 49, P<. 01 ). These data suggest that the Index ver. SCI(PQI)are used as scales of QOL, but adoption of comprehensive programs such as QOL scales effective for psychological evaluation have guideline-based protocols at long-term care facilities not been identified2). has a positive effect on promoting healing of pressure There was one time-series studyconcerning the ulcers. QOL of elderlypressure ulcer patients 4), and there was one transversal studyconcerning the QOL of References home care pressure ulcer patients5). A longitudinal 1)Vu T, Harris A, Duncan G, et al : Cost-effectiveness of multivariate analysis was conducted on the basis of multidisciplinarywound care in nursing homes : a reports filed everysix months bynursing home pseudo-randomized pragmatic cluster trial. Fam residents in which the participants reported the Pract, 24(4):372-379, 2007.(LevelⅡ) relationship between changes in their QOL and the 2)Xakellis GC, Frantz RA, Lewis A, et al : Translating prevalence of their pressure ulcers. The results of the pressure ulcer guidelines into practice : Itls harder studyindicated an inverse relationship between the than it sounds. Adv Skin Wound Care, 14(5):249- prevalence of pressure ulcers( StageⅡ or higher ) 256, 258, 2001.(LevelⅣ) and the sense of autonomy, security, and psychologic- al well-being reported bythe patients at six-month CQ 13 QOL/ Pain intervals4). CQ 13. 1:How can the qualityof life( QOL )of A cross-sectional study5) in home care pressure pressure ulcer patients be assessed? ulcer patients showed that the scores of physical [Recommendation]The QOL of the patients may functioning( p<0. 001 )and social role functioning be assessed along physiological, psychological, and (p<0.001)of the SF-36TM(a widelyaccepted scale social parameters. used to assesskHealth Related Qualityof Lifel), self- [Rating]C1 care(p=0.010), and mobility(p=0.001)were signi- [ Analysis ]Concerning factors that affect the ficantlylower, and bodilypain was stronger( p= health-related QOL of pressure ulcer patients, there is 0.042). one systematic review that accumulated quantitative Thus, as pressure ulcer exerts physical, psycholo- and qualitative studies1). There were the following 11 gical, and social effects, the assessment of the QOL is factors that affect the health-related QOL of pressure important, but which scale should be used is still ulcer patients : Physical effects and limitations, effects unclear. Therefore, the recommendation level was of symptoms of pressure ulcer, disagreement between rated as C1. the patient needs and the effects of intervention, References effects on overall health, psychological effects, recog- nition of the cause( anger at the inadequacyof 1)Gorecki C, Brown JM, Nelson EA, et al : Impact of preventive care), desire for knowledge, social effects, pressure ulcers on qualityof life in older patients : a relationship with healthcare providers, other impacts, systematic review. J Am Geriatr Soc, 57(7):1175- and economic problems. 1183, 2009.(LevelⅠ) There were 1 systematic review2) and one descrip- 2)Hitzig SL, Balioussis C, Nussbaum E, et al : Identifying tive transversal study3) concerning the QOL of and classifying quality-of-life tools for assessing pressure ulcer patients with spinal cord injury. A pressure ulcers after spinal cord injury. Spinal Cord descriptive and transversal studyconducted by Med, 36(6):600-615, 2013.(LevelⅠ) Blanes et al. reported that among out-patients with 3)Blanes L, Carmagnani MI, Ferreira LM : Qualityof life traumatic spinal cord injuries, the average mental and self-esteem of persons with paraplegia living in

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São Paulo, Brazil. Qual Life Res, 18(1):15-21, 2009. conducted on 32 patients with stageⅡ, Ⅲ, or Ⅳ (LevelⅤ) pressure ulcers interned at acute care, extended care, 4)Degenholtz HB, Rosen J, Castle N, et al : The and home care settings using the MPQ(McGill pain association between changes in health status and questionnaire ), 87. 5% reported feeling pain when nursing home resident qualityof life. Gerontologist, 48 their dressings were changed, and 84. 4% reported (5):584-592, 2008.(LevelⅣ) similar sensations when at rest1). Furthermore, 42% of 5)Franks PJ, Winterberg H, Moffatt CJ : Health-related the patients reported continuous pain. These data qualityof life and pressure ulceration assessment in indicate the need to assess pain levels in pressure patients treated in the community. Wound Repair ulcer patients not onlywhen treatment is adminis- Regen, 10(3):133-140, 2002.(LevelⅤ) tered but also when the patients are at rest.

References CQ 13.2:For which stage of pressure ulcer is pain assessment recommended? 1)Szor JK, Bourguignon C : Description of pressure [Recommendation]Pain maybe assessed at any ulcer pain at rest and at dressing change. J Wound stage of pressure ulcer. OstomyContinence Nurs, 26( 3 ) :115-120, 1999. [Rating]C1 (LevelⅤ) [Analysis]A cross-sectional study of 32 patients recruited from acute care settings, extended care CQ 13. 4:Which tools can be used to assess settings, and home care settings with stageⅡ,Ⅲ, and pressure-ulcer-related pain? Ⅳ pressure ulcers found that 75% reported mild pain, [ Recommendation ]Pressure-ulcer-related pain while 18% reported excruciating pain1). Another cross- maybe assessed using a subjective pain assessment sectional studybased on an interview of 44 patients in scale. an acute care setting reported a correlation between [Rating]C1 the VAS(visual analog scale)and stage of pressure [Analysis]A cross-sectional study based on inter- ulcer(r=0.37, P<0.01), with a positive correlation views of 44 patients with StageⅠ-Ⅳ pressure ulcers between the depth of the wound and the intensityof interned in an acute care facilityfound that the degree pain2). However, pain has reportedlyaccompanied of pain reported bythe patients in the interviews even relativelyshallow wounds 1). Accordingly, pain correlated with the VAS(visual analog scale ; r=0.59, assessment is necessaryat everystage of pressure P<0.1)as well as with the FRS(faces pain rating ulcer for the accurate assessment of patientsl QOL. Scale ; r=0.53, P<0.1)1). Another cross-sectional studyof 47 patients with References StageⅡ-Ⅳ pressure ulcers found that 94. 6% of pa- 1)Szor JK, Bourguignon C : Description of pressure tients who reported pressure-ulcer-related pain ulcer pain at rest and at dressing change. J Wound showed a correlation between their FRS and MPQ OstomyContinence Nurs, 26( 3 ) :115-120, 1999. ( McGill pain questionnaire )scores( r=0. 90, (LevelⅤ) P<0.001)2). These data indicate that the VAS, FRS, 2)Dallam L, Smyth C, Jackson BS, et al : Pressure ulcer and MPQ subjective rating systems are able accurate- pain : assessment and quantification. J Wound lyto measure the degree of pain felt bypressure ulcer OstomyContinence Nurs, 22( 5 ) :211-218, 1995. patients and are therefore appropriate tools for the (LevelⅤ) assessment of pressure-ulcer-related pain.

References CQ 13. 3:When should pain assessment be con- ducted? 1)Dallam L, Smyth C, Jackson BS, et al : Pressure ulcer [Recommendation]Pain assessment maybe con- pain : assessment and quantification. J Wound Ostomy ducted during treatment and time with no treatment Continence Nurs, 22(5):211-218, 1995.(LevelⅤ) including rest. 2)Günes UY : A descriptive studyof pressure ulcer [Rating]C1 pain. OstomyWound Manage, 54( 2 ):56-61, 2008. [ Analysis ]According to a cross-sectional study (LevelⅤ)

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