―12― 褥瘡会誌（Jpn J PU），16（1）：12〜90，2014

JSPU Guidelines for the Prevention and Management of Pressure Ulcers（3rd Ed.）

The Japanese Societyof Pressure Ulcers Guideline Revision Committee

Committee Chairperson : *Ryoji Tsuboi 1) Vice Chairperson : Makiko Tanaka2) Committee Members : Takafumi Kadono3), Yayoi Nagai4), Katsunori Furuta5), Yasuhiro Noda6), Yusuke Sekine7), Toshiko Kaitani8), Hitomi Kataoka9), Hiromi Nakagawa10), Taku Iwamoto11), Masakazu Kurita12), Mikio Kinoshita13), Yuta Kurashige14), Gojiro Nakagami15), Shoko Kakizaki16), Masami Hidaka17), Hideyuki Hirose18), Masaharu Sugimoto19), Masako Miyajima20), Madoka Noguchi21), Mayumi Okuwa22), Mihoko Ishizawa23), Yukiko Kinoshita24), Masayo Sobue25), Yoko Murooka26), Yuko Matsui27), Tomoko Ohura28) Advisers : Chizuko Konya29), Shigeru Ichioka30), Junko Sugama22), Hideko Tanaka26), Kayoko Adachi16), Takeo Nakayama31) Trustee : Yoshiki Miyachi32）

1)Tokyo Medical University, Department of Dermatology; 2)Yamaguchi Prefectural University, Faculty of Nursing and Human Nutrition; 3)Universityof TokyoFacultyof Medicine, Department of Dermatology;4) Gunma UniversityGraduate School of Medicine, Department of Dermatology;5)National Center for Geriatrics and Gerontology, Department of Clinical Research and Development; 6)Kinjo Gakuin University College of Pharmacy; 7)Tokyo Medical University Hospital, Department of Pharmacy; 8)Sapporo City University School of Nursing, Adult Nursing; 9)Yamagata UniversitySchool of Medicine, Department of Nursing; 10)Yokohama Soei UniversityFacultyof Nursing; 11)Tomei Atsugi Hospital, Department of Plastic Surgery;12)KyorinUniversity School of Medicine Department of Plastic Surgery; 13)Tokyo-Nishi Tokushukai Hospital, Department of Plastic and Reconstructive Surgery; 14 ) Tokyo Medical University Hachioji Medical Center, Department of Dermatology; 15)University of Tokyo Graduate School of Medicine, Division of Health Science and Nursing, Department of Gerontological Nursing/ Wound Care Management; 16 ) Sempo Tokyo Takanawa Hospital, Department of Clinical Nutrition; 17)Hyogo University of Health Sciences, School of Rehabilitation, Department of Physical Therapy; 18)Research Institute, National Rehabilitation Center for Persons with Disabilities; 19) Kobegakuin UniversityFacultyof Rehabilitation; 20)WakayamaMedical University,Department of Health and Nursing Sciences; 21)Kobe UniversityHospital; 22)Kanazawa UniversityFacultyof Health Sciences, Institute of Medical, Pharmaceutical and Health Sciences; 23 ) Nara Medical UniversitySchool of Medicine, Facultyof Nursing; 24)Gifu UniversityHospital Health Administration Center; 25)JA Aichi Konan Kosei Hospital; 26) Shukutoku UniversitySchool of Nursing and Nutrition; 27)Kanazawa Medical University,School of Nursing, Department of Human Science and Fundamental Nursing; 28 ) Seijoh UniversityFacultyof Care and Rehabilitation, Division of Occupational Therapy; 29 ) Kanazawa Medical University School of Nursing; 30 ) Saitama Medical University, Department of Plastic and Reconstructive Surgery; 31)Kyoto University School of

＊Correspondence : Ryoji Tsuboi, MD, PhD Department of Dermatology, Tokyo Medical University 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan Tel & Fax :（+ 81）-3-3340-1855 E-mail : [email protected]

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Public Health, Department of Health Informatics; 32)Kyoto University Graduate School of Medicine, Department of Dermatology. Abstract

The Japanese Societyof Pressure Ulcers（JSPU）has compiled an English version of the updated third 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-calledXwrap therapyYused 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.

4）A journal-style format consisting of discussion of Introduction treatment followed bythat of prevention. 1．Background 5）Inclusion of algorithms and flow-charts. In 2005, the Japanese Societyof Pressure Ulcers 2．Purpose and Scope publishedXGuidelines for Local Treatment of Press- The purpose of the present guidelines is to provide ure UlcersY1）and followed this in 2009 bya revised the best and most comprehensive recommendations edition,XGuideline for Prevention and Management possible, based on the most recent and reliable of Pressure Ulcers2）. The current guidelines repre- evidence, for the treatment of pressure ulcers for the sent the culmination of an effort headed bythe Fourth benefit of the full range of health care professionals Academic Education Committee to present an up-to- who are in anywayinvolved in the management and date set of guidelines in article format incorporating prevention of this condition. Crucially, the recom- new evidence collected since the publication of the mendations offered in the guidelines have been last edition. In addition to these new guidelines, a formulated with a view to addressing the special handbook designed for quick reference, containing needs of such health care professionals in their photographs and diagrams to facilitate the prevention respective clinical settings and to helping them to and management of pressure ulcers, has been make the best clinical decisions possible in their published. circumstances. While Europe and North America jointlypublished It should be noted that while these guidelines aim to NPUAP/EPUAP guidelines for pressure ulcers in be comprehensive in their scope, theyare also 2009 3）, the guidelines set forth here were designed designed to maximize the expertise and experience of with due consideration of medical issues specific to the individual health care professional and the Japan. This fact, together with the volume and quality resources available in each particular clinical setting of the data gathered, as well as the recommendation in order to achieve the best possible outcome for ratings provided, make the current set of guidelines individual patients and their familyor caretakers. By fundamentallysuperior to the latest revised edition in means of these new guidelines, we hope to set a new terms of clinical utility. and higher standard for pressure ulcer care in Japan Special attention was paid to a number of issues in through improvements in the qualityof pressure the compilation of the new guidelines, including the ulcer prevention and management, as well as in the following: better guidance which health care professionals will 1）The addition of new Clinical Questions（CQs）. be able to offer patients and their families. 2）The inclusion of CQs reflecting the latest medi- 3．Guideline Developers cal issues and the recommendations tailored specifi- The present guidelines are the result of a collabora- callyto the conditions of clinical practice. tive effort between members of the Fourth Academic 3）The inclusion of a CQ on the so-calledXwrap Education Committee of the Japanese Societyof therapyYused in Japan. Pressure Ulcers（see list of authors）, and incorporate

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some of the aims and contents of theXGuidelines for equipment, materials, topical medications, and dres- Local Treatment of Pressure Ulcers Y1）（ first ed., sings mentioned in the present guidelines are 2005 ）and theX Guideline for Prevention and Man- obtainable in Japan. If anyare unavailable in Japan, agement of Pressure Ulcers2）（Second edition, 2009）. this fact has been dulynoted. A list of those who participated in the development of 2）Evidence level and recommendation rating these past editions is presented below, bywayof The criteria for determining the evidence levels and acknowledging their valuable efforts. ratings for recommendation of the present guidelines First Edition（2005）1） were formulated with reference to the Japanese Yoshiki Miyachi（ Chairperson ）, Hiromi Sanada Guidelines for the Management of Stroke 2009,5） the （Vice Chairperson）, Junko Sugama, Takao Tachibana, Minds Reference Guide 2007 for Writing Clinical Motonari Fukui, Katsunori Furuta, Toshiko Kaitani, Practice Guidelines,4）and Clinical Practice Guidelines Keiko Tokunaga, Toshio Nakajo, Yoshio Mino, Takehi- for Skin Cancer6）. ko Oura, Hiroaki Oka, Masahiro Tachi, Toru Fujii, （1）Classification of Evidence Levels Takahiko Moriguchi, Takeo Nakayama, Takashi Ⅰ：Systematic reviews/ meta-analyses Nagase, Masaharu Sugimoto, Masami Hidaka. ⅰ）Randomized controlled trials only Second Edition（2009）2） ⅱ）Randomized controlled trials, cohort studi- Masutaka Furue（ Chairperson ）, Hiromi Sanada es, case-control studies （ Vice Chairperson ）, Takao Tachibana, Takafumi ⅲ）Sources not including i）and ii） Kadono, Toshiko Kaitani, Hiroaki Oka, Takashi Ⅱ：Randomized controlled trials Nagase, Masahiro Tachi, Takeo Nakayama Makiko Ⅲ：Non-randomized controlled trials Tanaka, Mayumi Okuwa, Junko Sugama, Noriko （Including historical controlled trials,* and self- Matsui, Yukie Kitayama, Keiko Tokunaga, Kayoko controlled studies） Adachi, Shingo Okada, Masami Hidaka, Hideyuki Ⅳ：Analytical epidemiological research（in cohort Hirose, Chizuko Konya. 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 series） database, CINAHL, and ALL EBM Reviews which （Including non-controlled intervention studies include the Cochrane Database Systematic Reviews, and cross-sectional studies） ACP Journal Club, Database of Abstracts of Reviews Ⅵ : Expert opinion of specialist committees or of Effect（DARE）and Cochrane Central Register of indivi-duals. Not based on patient data. Controlled Trials（ CCTR ）. The information was The evidence levels of each guideline used to sourced from various other relevant guidelines, as determine the recommendation ratings have not been well as data assembled byindividual contributors. described. This information was assembled from January, 1980 *An historical controlled trial is a form of interven- to June, 2011. Systematic reviews and clinical trials, tion studydone in order to test the efficacyof a new especiallyrandomized clinical trials, were prioritized. form of treatment, and requires approval bythe ethics When these sources were unavailable, observational committee of the relevant institution before it is studies such as cohort studies and case-control studies performed. Unlike the randomized controlled studyin were collected. In the event that the latter were which subjects are divided into a randomized unavailable, the range of acceptable sources was intervention group and the control group, and the expanded to include case series. As a rule, evidence outcomes for each group are compared, the historical dealing chieflywith the outcome index was priori- controlled trial examines cases which were observed tized; however, for the Clinical Questions dealing with at some time in the past for a comparison of their nursing, evidence focusing on QOL as the chief treatment outcomes with those of the intervention outcome measure was also used. Animal studies and group receiving a new treatment. basic research was not included. As a rule, medical **An historical controlled study, like the historical

―G−3― ―15― controlled trial, examines cases which were observed dealing with injuries and cutaneous ulcers as well. In at some time in the past for comparison with an such cases, however, the strength of the recommenda- intervention group receiving a new form of treatment. tion was accordinglylowered. However, it differs from the historical controlled trail The endorsement of the guideline committee was in that it is a form of observational studyconducted as required for inclusion into the guidelines of treat- a part of dailyconsultation rather than an intervention ments which earned the rating C1, insofar as such studyconducted for the purposes of testing a new treatments were deemed valuable for clinical practice, form of treatment. even if theylacked sufficient evidence. （2）Recommendation Ratings 5．Funding and Conflict of Interest Ａ：Stronglyrecommended because supported Funding for the compilation of the present guide- byadequate evidence. lines was provided entirelybythe Japanese Societyof Ｂ：Recommended because supported bysome Pressure Ulcers and does not derive in anypart from evidence other organizations or industries. Further, the content C1：Maybe considered because supported by of each rating was decided bya vote of the guideline limited evidence revision committee. If anymember of the guideline C2：Not recommended because no supporting revision committee was found to have a conflict of evidence found interest in connection with anyitem, he or she was Ｄ：Not recommended because of invalid or asked to abstain from voting on the item in question. possiblyharmful findings 6．Definition of Terms e* Evidence fis defined as the findings of clinical The definition of the terms used in the present trials and epidemiological research. guidelines conforms to that laid down bythe （3）Criteria for Determining Recommendation 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 I DESIGN-R scales published bythe Japanese Societyof or high qualityLevel II source of evidentiarysupport. Pressure Ulcers to reflect the unique historyand However, anysystematicreview not dealing exclu- development of this project. sivelywith randomized controlled trials weakens the 7．Peer Reviews and Plans for Future Revisions strength of the rating. A rating of B requires at least The present guidelines were made possible bythe one source of inferior qualityLevel II or high quality contributions and peer reviews of numerous members Level III evidence, or failing this, an extremelyhigh of the guideline revision committee and based on the qualitysource of Level IV evidence. However, unanimous approval of all of the members, arrived at randomized controlled trials with small numbers of through the process of debate and discussion. During subjects and industrysponsorship earn a lower rating. this process, feedback from other members of the A rating of C1 requires an inferior Level II-IV, or a Japanese Societyof Pressure Ulcers was sought at high qualityLevel V, source of evidence, or alterna- two symposia held by the Society. Members were also tivelya Level VI evidence source endorsed bythe encouraged to submit their opinions via the Societyfs committee. A rating of C2 is based on sources lacking website. valid evidence, or providing invalid evidence, while a The present guidelines will be revised under the rating of D is based on high-qualitysources with leadership of the Academic Education Committee of invalid or harmful findings. the Japanese Societyof Pressure Ulcers at intervals of The commentaryand recommendations in guide- everyseveral years. lines published outside Japan were referred to References frequentlyfor their value in helping us to establish the criteria for determining the ratings presented here. 1 ）Japanese Societyof Pressure Ulcers: Guideline for In some of the CQs for which there was a paucityof local treatment of pressure ulcers, Shorinsha, Tokyo, evidence relating directlyto pressure ulcers, the 2005. range of sources was broadened to include those 2 ）Japanese Societyof Pressure Ulcers: Guideline for

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Prevention and Management of pressure ulcers, testing of its predictive validitywas omitted 5−8）with Shorinsha, Tokyo, 2009. the result that questions were raised as to its fitness to 3）European Pressure Ulcer AdvisoryPanel and Nation- quantitate the severityof patients fconditions, al Pressure Ulcer AdvisoryPanel: Prevention and although there was no question as to its abilityto treatment of pressure ulcers: clinical practice guide- assess changes in the condition of individual cases. line. National Pressure Ulcer AdvisoryPanel, Thus with a view to realizing a scale which would Washington DC, 2009. enable the health care professional not onlyto 4）The Minds Committee on Clinical Practice Guidelines: evaluate pressure ulcer progression but also predict The Minds Reference Guide 2007 for Writing Clinical its severityreliablyand accurately,revision of the Practice Guidelines, IGAKU-SHOIN Ltd., Tokyo, 2007. scale was begun in 2005. Since DESIGN had already 5）The Joint Committee on Guidelines for the Manage- been widelyused clinically,some preconditions were ment of Stroke: Japanese Guidelines for the Manage- called for, that is, the seven parameters measured by ment of Stroke 2009, KYOWA KIKAKU Ltd., Tokyo, DESIGN-P（P indicatesepocketforeundermin- 2009. ingf）were to remain unaltered. In order to make this 6）Saida T, Manabe M, Takenouchi T, et al : The Com- feasible, first, a large-scale（2598 cases）retrospective mittee on Clinical Practice Guidelines for Skin Cancer: case-series studywas conducted, followed bya Clinical Practice Guidelines for Skin Cancer. Jpn J prospective case-series studywith 1003 cases. For Dermatol, 117（12）, 1855-1925, 2007. each study, a large number of subjects were enrolled in both the healing and non-healing groups using the From DESGIN to DESIGN-R Cox hazard analysis. In 2002, the Academic Education Committee of the As a result, the parameters were ranked according Japanese Societyof Pressure Ulcers announced the to their weight as follows: pocket, size, inflammation/ DESIGN（Depth, Exudate, Size, Inflammation/Infec- infection, granulation tissue, exudates, and necrosis. A tion and Necrosis）scale in answer to needs: namely, positive correlation was found among these para- first, the need for a means of assessing pressure ulcers meters, excluding inflammation/infection, where a according to severity, and second, for a means of higher degree of severitywas accompanied bya quantifying aspects of the treatment process in terms higher weighting of the individual parameters9−11）.In of the wound parameters of depth, exudate, size, terms of background information, a comparatively inflammation/infection, granulation, and necrosis. large number of aged persons were enrolled. The Although scales with similar purposes, such as the facilities examined were mostlyuniversityhospitals Bates-Jansenfs Pressure Sore Status Tool（PSST）1）, and the number of home care settings was small. NPUAPfs Pressure Ulcer Scale for Healing（PUSH）2）, However, when Cox hazard analysis was conducted and Ohura fs Assessment of Pressure Ulcer-Healing using these factors as adjusted variables, there was no Process（PUHP）3）have alreadybeen put to practical change in weighting, demonstrating that the bias in use, each scale presents some difficulties which terms of the age and types of institution had no effect DESIGN attempts to address. DESIGN was developed on the scalefs weighting.9） on the basis of expert opinion and incorporates four In order to make the statisticallycalculated features, namely,its abilityto: 1）quantifyseverityof weightings more convenient for clinical use, the pressure ulcers and the healing process 2）monitor weighted values were simplified to be multiples of 3. intervention in term of each of the parameters Comparison of the weightings before and after their mentioned above and changes in wound surface 3） simplification showed that correlation was high at 0. provide a standard and convenient tool for use in the 991 while also affirming that the procedure did not clinical setting and 4）be compatible with internation- influence severityevaluation. Finally,the depth al standards for care and intervention. parameter values were found to be unrelated to the In order for such a scale to be readilyaccepted, it weighted values but rather to reflect the status of the was necessaryto test its inter-rater reliability,content pressure ulcer. For this reason it was not included in validity, construct validity, concurrent validity and the total score. In order to draw attention to the fact predictive validity. When DESIGN was developed, that weighting had been added as a novel feature, the

―G−5― ―17― name of the scale was changed from DESIGN to Education Committee of the Japanese Societyof DESIGN-R witheRfstanding forerating.fIn 2008 Pressure Ulcers. Clinical wound assessment using DESIGN-R was published and has since been widely DESIGN-R total score can predict pressure ulcer used throughout the Japan as a pressure ulcer healing: pooled analysis from two multicenter cohort assessment scale with acceptable predictive validity. studies. Wound Repair Regen, 19（5）: 559-567, 2011.

References Algorithm for Prevention and Management 1）Bates-Jansen BM, Vredevoe DL, Brecht M: Reliability of Pressure Ulcers of the pressure sore status tool. Decubitus, 5（ 6 ）: 20-28, 1992. The decision tree（Fig. 1）illustrates the process 2 ）National Pressure Ulcer AdvisoryPanel: Pressure bywhich procedures for the prevention and/or ulcer scale for healing（PUSH）,1998. management of pressure ulcers in the target popula- 3）Ohura T : Practical Guide for Pressure Ulcer Care. tion maybe designed. Shorinsha Inc, Tokyo, 102-109, 2001. First, subjects are given a general physical ex- 4）Ohura T, Miyachi Y, Sanada H, et al : The pressure amination and their risk of developing pressure ulcers ulcers state rating system: How to put and usage of is assessed. In cases in which there is no risk of the DESIGN. Shorinsha Inc, Tokyo, 6-9, 2003. developing pressure ulcers, the condition of the 5）Moriguchi T, Miyachi Y, Sanada H, et al : DESIGN-A subject continues to be monitored regularly. In cases new assessment tool for the classification and the where there is risk of developing pressure ulcers, local healing process in pressure ulcers-. Jpn JPU, 4（1）： inspection of the skin is performed and the presence 1-7, 2002. or absence of pressure ulcers is confirmed. In the 6）Sanada H, Tokunaga K, Miyachi Y, et al : DESIGN- absence of pressure ulcers, a suitable regimen of Reliabilityof the new pressure ulcer assessment tool-. preventive care（ Fig. 6 ）or general care（ Fig. 4 ） Jpn JPU, 4（1）：8-12, 2002. maybe designed and implemented. If a pressure ulcer 7）Sanada H, Moriguchi T, Miyachi Y, et al : Reliability is found, Fig.7or5maybe consulted in order to and validityof DESIGN, a tool for that classifies design an effective care regimen for treatment. Fig. 2 pressure ulcer severityand monitors healing. Wound and 3 maybe also consulted in order to determine the Care,13（1）: 13-18, 2004. most suitable treatment modality, such as conserva- 8 ）Matsui Y, Sugama J, Sanada H, et al : Predictive tive treatment or surgical intervention. Following validityand weighting of D-E-S-I-G-N: A wound successful implementation of this phase of patient healing progression tool. Jpn JPU, 7（1）：67-75, 2005. care, risk of further occurrence（or recurrence）of 9）Tachibana T, Matsui Y, Sugama J, et al : The Report pressure ulcers, the patientfs general physical condi- of arts and sciences Board of Education- Revision of tion, and state of existing pressure ulcers maybe DESIGN-. Jpn JPU, 10（4）：586-596, 2008. assessed as appropriate. 10）Matsui Y, Furue M, Sanada H, et al : Development of Table of Clinical Questions（CQ）s and the DESIGN-R with an observational study: an Accompanying Recommendations absolute evaluation tool for monitoring pressure ulcer wound healing. Wound Repair Regen, 19（3）: 309- Clinical questions（CQ）s and their accompanying 315, 2011. recommendations are shown in Table 1〜13. 11 ）Sanada H, Iizaka S, Matsui Y, et al : Scientific

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

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Table 1 Topical agents

Clinical Question Rating Recommendation Oleaginous preparations such as zinc oxide, dimethyl isopropylazulene, Which topical agents are recommended to CQ 1.1 C1 white petrolatum, with a high degree of efficacyin protecting wound treat acute pressure ulcers? surfaces, and silver sulfadiazine maybe considered. Close monitoring of the wound is important. Oleaginous preparations such Which topical agents are indicated in cases CQ 1.2 C1 as zinc oxide, dimethyl isopropylazulene and white petrolatum may be with suspected deep tissue injury(DTI)? considered. It is important in cases of redness/purpura to protect the wound surfaces. Which topical agents are recommended for CQ 1.3 C1 Dimethylisopropylazulene and white petrolatum may be used for this cases involving redness/purpura? purpose. Which topical agents are recommended for CQ 1.4 C1 White petrolatum or zinc oxide maybe used to protect the wound surface. cases involving blistering? Zinc oxide or dimethyl isopropylazulene may be used. Alprostadil alfadex, Which topical agents are recommended to CQ 1.5 C1 bucladesine sodium, or lysozyme hydrochloride may also be used to treat erosions and shallow ulcers? promote re-epithelialization. Are topical agents recommended if pain CQ 1.6 C2 There is no evidence supporting the use of topical agents to alleviate pain. accompanies the pressure ulcer?

Cadexomer-iodine and povidone-iodine sugar are both highlyabsorbant B Which topical agents are recommended for and are recommended for pressure ulcers with excessive exudate. CQ 1.7 pressure ulcers with excessive exudate? C1 Dextranomer and iodine ointment maybe considered.

Ointments with emulsion bases are preferred. Silver sulfadiazine maybe Which topical agents are recommended in CQ 1.8 C1 considered to treat infected wounds while tretinoin tocoferil maybe pressure ulcers with minimal exudate? considered to treat uninfected wounds. Cleanse the pressure ulcer using isotonic saline or tap water in sufficient CQ 1.9 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 CQ 1.10 How should pressure ulcers be disinfected? C1 wound is clearlyinfected or if there is excessive exudate or pus, the wound maybe disinfected using antiseptics prior to cleansing. Cadexomer-iodine, silver sulfadiazine, and povidone-iodine sugar are B Which topical agents are recommended for recommended for their abilityto control infections. CQ 1.11 pressure ulcers accompanied byinfection and Fradiomycin sulfate-trypsin, povidone-iodine, iodine ointment, and iodo- inflammation? C1 form gauze maybe considered. Aluminium chlorohydroxy allantoinate, trafermin, tretinoin tocoferil and Which topical agents are recommended to B povidone-iodine sugar, all of which are known to accelerate granulation CQ 1.12 accelerate granulation formation in pressure formation, are recommended. ulcers with deficient granulation formation? Alprostadil alfadex, bucladesine sodium, or lysozyme hydrochloride may C1 be considered. Which topical agents are recommended in Topical medications with an anti-microbial properties, such as cadexomer- CQ 1.13 pressure ulcers with deficient granulation C1 iodine ointment, povidone-iodine sugar, iodine ointment, or silver sulfa- formation and suspected critical colonization? diazine maybe used. Alprostadil alfadex, aluminum chlorohydroxy allantoinate, trafermin, B Which topical agents are recommended for bucladesine sodium, and povidone-iodine sugar are recommended. CQ 1.14 wound reduction in pressure ulcers with Zinc oxides, dimethyl isopropylazulene, extract from hemolyzed blood of sufficient granulation formation? C1 young calves, and lysozyme hydrochloride may be used.

Which topical agents are recommended if Cadexomer-iodine, silver sulfadiazine, dextranomer, bromelain or CQ1.15 C1 necrotic tissue is observed? povidone-iodine sugar maybe considered. If the undermining is covered bynecrotic tissue, the wound surfaces Which topical agents are recommended when should first be cleaned. Also, if there is excessive exudate, povidone iodine- CQ 1.16 C1 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, CQ 2.2 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, CQ 2.3 for pressure ulcers involving red- C1 either film dressings or dressings designed to treat transparent dermal wounds maybe ness/purpura? considered. While leaving the blisters intact, consider using a transparent film dressing to protect the Which dressings are recommended CQ 2.4 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, CQ 2.5 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 Which dressings are recommended maintaining a moist environment conducive to wound healing. When changing dressings, CQ 2.6 C1 for pressure ulcers involving pain? perform adequate pain assessment and apply a hydrocolloid, polyurethane foam, polyurethane foam/soft silicone, Hydrofiber®, chitin membrane, or hydrogel.

B Recommend using polyurethane foam dressings, which can absorb excess exudates. Which dressings are recommended in CQ 2.7 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®, or hydropolymer dressings, maybe applied.

Which dressings are recommended B Using a hydrocolloid dressing is recommended. CQ 2.8 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. CQ 2.9 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 dressings are recommended for promoting granulation tissue Alginate, hydrocolloid, hydropolymer, polyurethane foam, polyurethane foam/soft silicone, CQ 2.10 C1 formation in pressure ulcers where it chitin membrane and Hydrofiber® maybe considered. is deficient? Which dressings are recommended in pressure ulcers with deficient gra- CQ 2.11 C1 Consider using silver-containing Hydrofiber® or alginate silver. nulation tissue formation and sus- pected critical colonization?

® Which dressings are recommended to B Using silver-containing Hydrofiber , alginate silver, or alginate is recommended. promote the reduction of the size of CQ 2.12 wounds with adequate/normal gra- Hydrocolloid, hydrogel, hydropolymer, polyurethane foam, polyurethane foam/soft ® nulation tissue formation? C1 silicone dressing, alginate foam, chitin membrane, Hydrofiber , alginate/CMC are also options, depending on the amount of exudate present. Which dressings are recommended If surgical debridement 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 CQ 2.14 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-calledewrap dressingf CQ 2.15 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. e* Wrap dressing fis a dressing technique of covering wounds with non-medically approved(unsterilized)and non-adhesive commerciallyavailable plastic wrap.

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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? C1 brought under control.

Is surgical incision or debridement recom- Surgical incision or debridement maybe considered for treating CQ 3.3 C1 mended if undermining is present? undermining 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, and the patient's level of pain tolerance. Reconstructive surgerymaybe considered for D3~D4 pressure ulcers that C1 do not respond to conservative treatment.

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. CQ 3.6 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― ―22―

Table 4 General management

Clinical Question Rating Recommendation Pelvic fractures, diabetes mellitus, cerebro-vascular diseases, Which underlying medical conditions may CQ4.1 C1 and spinal cord injuries potentiallylead to pressure ulcer entail the risk of leading to pressure ulcers? formation due to patient immobility. 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 Consider supplying the required nutrition by enteral tube- CQ4.3 C1 of nutrition and hydration be fed? feeding. When this is not possible, consider parenteral feeding. Preventive In the absence of inflammation or dehydration, serum albumin general C1 levels maybe used. manage- ment C1 Rate of weight loss maybe considered for use.

What indices can be used to assess the level Consider using the rate of food intake or the amount of food CQ4.4 of malnutrition as a risk factor for pressure C1 consumption as an index. ulcers? C1 Consider using Subjective Global Assessment（SGA）.

Mini Nutritional Assessment（ MNA ）maybe used with C1 elderlypatients. 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, consider administering systemic antibio- tients with an infected pressure ulcer? tics. If onlysymptomsof local infection are found, administration of systemic antibiotics need not be considered. Consider using empiric antibiotics to suspected pathogens Which antibiotics（ antimicrobials ）are re- common in clinical settings. Reconsider using more specific CQ4.6 C1 commended for treating infection? antibiotics to pathogens byreferring the results of susceptibility testing. Which underlying conditions may pose a Malignant tumors and cardiovascular diseases should be CQ4.7 risk of prolonging the healing of pressure C1 considered 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 occurrence In order to ensure adequate energyfor healing of pressure 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.

Should the diet of pressure ulcer patients be Patientsfdiet maybe supplemented with zinc, arginine, and CQ4.10 C1 supplemented with anyspecific nutrients? ascorbic acid to prevent deficiencies of these nutrients. 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― ―23―

Table 5 Rehabilitation

Clinical Question Rating Recommendation Which factors account for pressure ulcer Risk For patients with a historyof pressure ulcers, vigilance is CQ 5.1 development in chronic spinal cord injury B assessment recommended to prevent recurrence. patients? Which methods are effective for preventing Conducting rehabilitation while monitoring interface CQ 5.2 pressure ulcer development in spinal cord C1 pressure maybe considered. injurypatients? What type of cushion should be used with A pressure-redistributing seat cushion for individuals CQ5.3 elderlypatients in a seated position to prevent B with spinal cord injuryis recommended to prevent pressure ulcers? pressure ulcer development while seated. Should limitations be set on the length of time Limitations on sitting time should be set if the elderly CQ5.4 in which the individual remains continuously B individual is unable to reposition without assistance. seated? Repositioning every15 min is recommended for seated At what intervals should the seated individual CQ5.5 C1 individuals who are capable of changing their body be repositioned? Preventive position without assistance. care Should the individualfs posture while seated be The alignment and balance of the seated individual fs 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 CQ5.12 C1 Hydrotherapymaybeconsidered. patients with infected pressure ulcers?

What kind of physical modality can be used for Consider hydrotherapy or pulsatile lavage with or CQ5.13 C1 Conservative pressure ulcers containing necrotic tissue? without suction. treatment Implementing electrical stimulation therapyis recom- B What kind of physical modality can be used to mended. CQ5.14 promote wound reduction? Near infrared therapy, ultrasonic therapy, or electro- C1 magnetic therapymaybe considered.

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.

―G−12― ―24―

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 CQ 7.1 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.

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 fecal incontinence in C1 skin emollients can be applied to the anal/genital area order to prevent development of pressure ulcers? and to the peripheral skin.

What type of preventive skin care is recommended Transparent film dressings and other dressings with a CQ8.2 B for use on bonyprominences in elderlypatients? low-friction external surface are recommended. Preventive care What kind of skin care is recommended for patients A transparent film dressing can be applied to the CQ8.3 C1 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? How should the skin surrounding a pressure ulcer Cleansing with a mildlyacidic cleansing agent maybe CQ8.5 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 CQ8.6 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 Consider repositioning the patient at least everytwo CQ9.1 C1 repositioned to prevent pressure ulcer? hours. When a visco-elastic foam mattress is being used, C1 consider repositioning the patient at least everyfour How frequentlyshould bed bound patient be hours. CQ 9.2 repositioned when a support surface is being used? When a double-layer air-cell mattress overlay is being Preventive C1 used, consider repositioning the patient at least every care four hours. When repositioning bed bound patients, what A 30- and 90-degree angle for the laterallyrecumbent CQ 9.3 positions should be undertaken to avoid pressure C1 position maybe considered. ulcer formation? How can patients in intensive care be repositioned The patient maybe repositioned in an electric rolling CQ 9.4 C1 in order to prevent pressure ulcer formation? hospital bed. What positions should be undertaken to promote Anyposition besides the 30-degree tilted side-lying Care after CQ 9.5 healing in patients with pressure ulcers in the C1 position or head-of-bed elevated position maybe occurrence gluteal region? undertaken.

―G−13― ―25―

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 B patients at risk of developing pressure ulcers. Preventive In addition to using support surfaces, visco-elastic pads or gel care B applied to the heel area, cubital region, and other areas with bony Which tools, including support sur- prominences is recommended during operations. 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 Which support surfaces provide the mended. CQ10.7 greatest comfort both while awake and For terminallyill patients, an alternating-pressure air mattress with sleeping? 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 patientfs position and weight function replace- Which support surfaces are recom- C1 ment, an alternating-pressure large-cell ripple mattress, a double- Care after CQ10.9 mended for promoting healing in d1, d2, layer air-cell mattress, or a low air pressure mattress may be occurrence and D3~D5 pressure ulcers? considered to promote 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 patientfs weight and position maybe considered after flap reconstruction for pressure ulcers.

―G−14― ―26―

Table 11 Patient education

Clinical Question Rating Recommendation Education/training in repositioning and using support surfaces can C1 be carried out . Periodic telephone consultations with a health care professional C1 and/or remote assessment of the patient fs skin condition using How can patients and their familyor electronic visual media maybe done. Preventive caregivers be educated to prevent the CQ 11.1 Education byan e-learning systemled bythe health care care development or recurrence of pressure C1 ulcers? professional maybe given. 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 management of incontinence. How should patients/family/caregivers Consider informing patient/family/caregiver how to contact an Care after CQ11.2 be educated/trained in the care of C1 appropriate medical center for help in the event the pressure ulcers occurrence existing pressure ulcers? worsen.

Table 12 Outcome management

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

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

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

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

Implementation of comprehensive programs and protocols maybe consi- C1 dered.

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−15― ―27―

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 at anytime（regardless of whether CQ13.3 When should pain assessment be conducted? C1 topical intervention is being administered）.

Which tools can be used to assess pressure- CQ 13.4 C1 Pain maybe assessed using a validated scale. ulcer-related pain?

―G−16― ―28―

Fig. 2 Algorithm illustrating conservative treatments

efficacious in protecting wound surfaces, such as Guidelines white petrolatum, are preferred for treatment1）.Ifthe CQ 1 Topical agents ulcer surface is infected, silver sulfadiazine and similar CQ 1.1：Which topical agents are recommended to preparations with nonspecific anti-bacterial prop- treat acute pressure ulcers? erties are recommended, as antibiotic topical agents ［Recommendation］Oleaginous preparations such typically fail to produce the desired effect. as zinc oxide, dimethyl isopropylazulene, white References petrolatum, with a high degree of efficacyin protecting wound surfaces, and silver sulfadiazine 1）Kawakami S, Shimada K：Treatment of acute pres- maybe considered. sure ulcers. Modern Physician, 28：506-507, 2008. ［Rating］C1 （Level VI）（Japanese） ［Analysis］At present, observations of only a most general nature exist regarding the choice of topical CQ 1.2：Which topical agents are indicated in cases agents for the treatment of acute pressure ulcers1）. with suspected deep tissue injury（DTI）? As a first step, it is critical to ascertain the cause of the ［Recommendation］Close monitoring of the wound injurybefore considering the typeof topical therapy is important. Oleaginous preparations such as zinc to employ. This is underscored by the fact that in oxide, dimethyl isopropylazulene and white petrola- manycases of acute pressure ulcers, the presence of tum maybe considered. deep tissue damage mayat first go unnoticed, and ［Rating］C1 lead naturallyto an exacerbation of the condition. For ［Analysis］At present, only expert opinion exists this reason, the basic considerations when employing regarding the choice of topical agents for the topical therapyto treat acute pressure ulcers include treatment of deep tissue injuries（DTI）. The term maintaining an optimallymoist environment condu- DTI was proposed bythe NPUAP（2007）to define a cive to wound healing while closelymonitoring for condition in which the appearance of overlying skin changes in the condition of the wound itself. Typically, conceals the actual extent of damage to underlying oleaginous preparations that are known to be highly tissue, which becomes more apparent with time as the

―G−17― ―29― wound evolves into deeper layers of tissue1）. Treatments prioritize wound surface protection and If deep tissue injuryis suspected, pressure should tend to focus on the type of dressing used for this be relieved immediatelyand the condition of the purpose. However, blisters maybe punctured if tense, wound closelymonitored. The wound maybe and ruptured blisters mayrequire treatments usually occluded if necessary, but in a manner which will employed for erosions and ulcers. In cases where allow the condition of the wound to be readily topical agents are employed, white petrolatum or monitored. Zinc oxide, dimethyl isopropylazulene, or similar petrolatum-based topical agents are preferred white petrolatum and other oleaginous preparations for their abilityto stimulate wound healing while are recommended. protecting the wound surface. Although zinc oxide in a petrolatum-based preparation is customarilyem- References ployed for this purpose not only because of its locally 1 ）Kadono T：Deep tissue injury. Rinsho Hifuka, 63 astringent effects and mildlyantiseptic properties, but （5）：38-41, 2009.（Level VI）（Japanese） also for its abilityto protect the wound surface and reduce inflammation while promoting tissue CQ 1.3：Which topical agents are recommended for regeneration1）, its efficacyis generallyweak. cases involving redness/purpura? References ［ Recommendation ］It is important in cases of redness/purpura to protect the wound surfaces. 1 ）Edited bythe Japanese Pharmacopoeia Instruction Dimethyl isopropylazulene and white petrolatum may Manual Editorial Committee. The Japanese Pharma- be used for this purpose. copoeia, Fourteenth Edition: Text with Annotations, ［Rating］C1 1257-1259, Hirokawa Publishing Company, Tokyo, ［ Analysis ］Only expert opinions are available to 2001.（Level VI）（Japanese） treat non-blanchable redness and purpura. Treat- ments prioritize the protection of wound surfaces and CQ 1.5：Which topical agents are recommended to tend to focus on the types of dressing used for this treat erosions and shallow ulcers? purpose. In cases which call for treatment using ［ Recommendation ］Zinc oxide or dimethyl isop- topical agents, white petrolatum or similar, ropylazulene may be used. Alprostadil alfadex, petrolatum-based topical agents are preferred for bucladesine sodium, or lysozyme hydrochloride may their abilityto stimulate wound healing while also be used to promote re-epithelialization. protecting the wound surfaces. Although dimethyl ［Rating］C1 isopropylazulene in a petrolatum-based preparation is ［ Analysis ］The choice of topical agent for the sometimes used for the treatment of non-blanchable treatment of erosion and shallow ulcers is based only redness and purpura because of its anti-inflammatory on expert opinion. As the treatment of erosion and properties and reducing effects on edema1）, its shallow ulcers should prioritize protecting the wound efficacyis generallylow. surface and maintaining an optimallymoist environ- ment, the choice of dressing becomes crucial. White References petrolatum or other preparations with a petrolatum 1）Nakamura I, Ozaki M, Watanabe B：Anti-inflammatory base are often chosen for their efficacyin promoting effects of azulen. Rinsho Hifuka, 12：769-778, 1958. wound healing while protecting the wound surface. （Level VI）（Japanese） Although zinc oxide, available as a petrolatum-based ointment, is not highlyefficacious, it possesses mild, CQ 1.4：Which topical agents are recommended for locallyastringent, protective, and antiseptic, prop- cases involving blistering? erties while simultaneouslyreducing inflammation ［Recommendation］White petrolatum or zinc oxide and promoting tissue regeneration. Dimethyl isop- maybe used to protect the wound surface. ropylazulene, also available in a petrolatum base, is ［Rating］C1 well-known for its anti-inflammatoryproperties and ［ Analysis ］The choice of topical agent for the its reducing effect on edema1）, but its efficacyis treatment of blisters is based onlyon expert opinion. generallylow.

―G−18― ―30―

Alprostadil alfadex, available in a preparation using relieve pain, although its usefulness for this purpose Plastibase®, is effective in stimulating wound healing has yet to be established. In summary, there is still bypromoting re-epithelialization, skin blood flow, and insufficient evidence to recommend the use of topical angiogenesis2）. While being a potent pro-circulatory agents for the relief of pain associated with pressure agent, it is sometimes irritant to the skin. Bucladesine ulcers. sodium possesses superior absorbancydue to its References macrogol base and is recommended for cases with excessive exudate. Other effects of bucladesine 1）Flock P：Pilot studyto determine the effectiveness of sodium are: reduction of ulcer size, wound contraction, diamorphine gel to control pressure ulcer pain. J Pain local pro-circulatoryeffects, angiogenesis, granulation Symptom Manage, 25：547-554, 2003.（Level II） tissue promotion, and re-epithelialization. Lysozyme 2）Zeppetella G, Paul J, Ribeiro MD：Analgesic efficacy hydrochloride is available in an emulsion base and is of morphine applied topicallyto painful ulcers. J Pain used with the aim of reducing wound size. While Symptom Manage, 25：555-558, 2003.（Level II） promoting keratinocyte and fibroblast growth, lysozy- me hydrochloride is minimally irritant to the skin. CQ 1.7：Which topical agents are recommended for In summary, zinc oxide, and dimethyl isopropyla- pressure ulcers with excessive exudate? zulene, as well as alprostadil alfadex, bucladesine ［Recommendation］ sodium, and lysozyme hydrochloride are assigned ．Cadexomer-iodine and povidone-iodine sugar Rating for Recommendation C1 for their efficacyin are both highlyabsorbant and are recommended for promoting re-epithelialization. pressure ulcers with excessive exudate. ［Rating］B References ．Dextranomer and iodine ointment maybe 1 ）Nakamura I, Ozaki M, Watanabe B, et al：Anti- considered. inflammatoryeffects of azulene. Rinsho Hifuka, 12： ［Rating］C1 769-778, 1958.（Level VI）（Japanese） ［ Analysis ］Cadexomer-iodine, fibrinolysin- 2 ）Imamura S, Sagami S, Ishibashi Y, et al：Clinical deoxyribonuclease-containing ointment, dextranomer studyof prostaglandin E1 ointment（G-511 ointment） and dextrin-polymer-base were tested to determine in chronic skin ulcers. Well-controlled comparative their relative efficacyin alleviating excessive exuda- study with lysozyme chloride ointment. J Clin Ther tion in pressure ulcers. The results of the test Med, 10：127-147, 1994.（Level II）（Japanese） indicated an improvement rate of 65. 8% for cadexomer-iodine in comparison with fibrinolysin- CQ 1.6：Are topical agents recommended if pain deoxyribonuclease-containing ointment（46.2%）, de- accompanies the pressure ulcer? monstrating a statisticallygreater effect for the ［Recommendation］There is no evidence support- former（p ＜ 0.05）1）. ing the use of topical agents to alleviate pain. The studyalso indicated an improvement rate of 65. ［Rating］C2 2% for cadexomer-iodine in comparison with dextra- ［ Analysis ］Randomized controlled trials using nomer（18.2%）, likewise demonstrating the statisti- topical applications of morphine to relieve pain callysignificantlygreater efficacyof the former（p ＜ associated with pressure ulcers have been conducted 0.01）2）. On the other hand, cadexomer-iodine showed outside Japan, 1, 2） but the use of morphine is not an efficacyrate of 33. 3% in comparison with the common in this country. However, pain control during dextrin-polymer-base（24%）with no significant dif- the acute phase of pressure ulcer is critical. Also, as ference in efficacyobserved 3）. manypatients are incapable of reporting sensations of The ameliorative effect of povidone-iodine sugar on pain themselves, the task of bearing in mind the exudation has been compared with that of lysozyme patientSs susceptibilityto pain and the possible need to hydrochloride ointment in two studies, and with that administer suitable analgesics devolves upon the of ointment containing extract from hemolyzed blood attending physician. Xylocaine jelly is among the of young calves in one study. The latter study topical medications sometimes used in Japan to demonstrated a significantlyhigher efficacyrate of

―G−19― ―31―

25% for povidone-iodine sugar in comparison with 0% （SS-094 : Ointment）. Jpn Pharmacol Ther, 17（4）： for ointment containing extract from hemolyzed blood 1789-1813, 1994.（Level II）（Japanese） of young calves（p ＜ 0.01）4）. 5 ）Saito Y, Furuse Y, Ishii T, et al：A clinical rando- The two studies comparing the efficacyrate of mized comparative studyof povidone-iodine-sugar povidone-iodine sugar and lysozyme hydrochloride ointment（ U-PASTA KOWA ）versus combined have yielded opposite results, with one study indicat- ointment with lysozyme hydrochloride ointment ing an efficacyrate of 25% for povidone-iodine sugar （ REFLAP Ointment ）and povidone-iodine-sugar and 33. 3% for lysozyme hydrochloride and no ointment（ U-PASTA KOWA ）on decubitus. Jpn statisticallysignificant difference in the results 5）, while Pharmacol Ther, 22（ 5 ）：2403- 2413, 1994.（ Level the second studyindicated an efficacyrate of 49.1% II）（Japanese） for povidone-iodine sugar and 27. 8% for lysozyme 6）lmamura S, Uchino H, Imura Y, et al：The clinical hydrochlorideand a statisticallygreater efficacyrate effect of KT-136（ sugar and povidone-iodine oint- for the former（p ＜ 0.01）6）. ment）on decubitus and skin ulcers: A comparative Further, a retrospective analysis of a case in which study with lysozyme ointment. Jpn Pharmacol Ther, the DESIGN score decreased following the application 17（Suppl.1）：255-279, 1989.（Level II）（Japanese） of povidone-iodine sugar failed to establish any 7）Kobayashi A, Muto S, Chino K, et al：Analysis of the relationship between the amount of exudate and the therapeutic effictiveness of a topical agent in the decrease in the DESIGN score7）. treatment of pressure ulcers using DESIGN. Jpn J PU, The ameliorative effect of dextranomer and iodine 10（2）：111-116, 2008.（ Level V ）（ Japanese, En- ointment on exudation has been documented in past glish abstract） case reports. Of the five cases reported, four 8）Horio T, Kawai S, Moriguchi T, et al：Therapeutic demonstrated a decrease in the initiallymedium to effects of SK-P-9701（dextranomer paste）on press- high levels of exudation following treatment with ure ulcers. Jpn J JPU, 3（3）：355-364, 2001.（Level dextranomer8）. Furthermore, case reports have V）（Japanese, English abstract） documented a significant improvement in the 9）Nagai Y, Amano H, Okada E, et al：Therapeutic effe- DESIGN-R score and the E score in DESIGN following ctiveness of Iodocoat® ointment 0.9% in the treatment iodine ointment treatment9, 10）. of pressure ulcers. J New Rem & Clin, 59（ 7 ）： In summary, for the treatment of excessive 1215-1223, 2010.（Level V）（Japanese） exudation cadexomer iodine and povidone-iodine 10）Tachibana T, Fujii N, Wakabayashi M, et al：Thera- sugar are assigned a rating of B, while dextranomer peutic effect of 0. 9% iodine-containing ointment on and iodine ointment are assigned a rating of C1. yellow stage of pressure ulcers. Jpn JPU, 12（ 4 ）： 513-519, 2010.（ Level V ）（ Japanese, English ab- References stract） 1）Kukita A, Ohura T, Aoki T, et al：Clinical evaluation of NI-009 on various cutaneous ulcers. Comparative CQ 1.8：Which topical agents are recommended in studywith Elase-C Ointment. J Clin Ther Med, 6 pressure ulcers with minimal exudate? （4）：817-848, 1990.（Level II）（Japanese） ［ Recommendation ］Ointments with emulsion 2 ）lshibashi Y, Ohkawara A, Kukita A, et al：Clinical bases are preferred. Silver sulfadiazine maybe evaluation of NI-009 on various cutaneous ulcers. considered to treat infected wounds while tretinoin Comparative studywith Debrisan. J Clin Ther Med, 6 tocoferil maybe considered to treat uninfected （4）：785-816, 1990.（Level II）（Japanese） wounds. 3）Anzai T, Shiratori A, Ohtomo E, et al：Evaluation of ［Rating］C1 clinical utilityof NI-009 on various cutaneous ulcers. ［ Analysis ］There are no evidence-based reports Comparative studywith base. J Clin Ther Med, 5 besides expert opinion recommending topical agents （12）：2585-2612, 1989.（Level II）（Japanese） for the treatment of minimallyexudative wounds 1−3）. 4 ）KT-136 Skin Ulcers Comparative StudyGroup： Emulsion-base ointments are typically recommended Comparative clinical studyof sugar and povidone- for such wounds, both byreason of their high iodine ointment（KT-136）and solcoseryl ointment moisture content and penetrating ability. Emulsion-

―G−20― ―32― base ointments also have the added benefit of the 12 cases cleaned with 200 ml isotonic saline. promoting water retention in drywound surfaces. A In summary, while wound cleansing is effective in representative example of such an emulsion-base speeding recovery, there is no evidence to endorse a topical agent is silver sulfadiazine, which possesses particular cleansing solution or method. Pressure antibacterial properties and softens necrotic tissue, ulcers maybe cleaned adequatelybyusing sufficient and tretinoin tocoferil, which promotes granulation quantities of isotonic saline or tap water. tissue formation1−3）. References In summary, silver sulfadiazine and tretinoin tocoferil are assigned a recommendation of C1 for the 1）Moore Z, Cowman S：A systematic review of wound treatment of minimallyexudative wounds. cleansing for pressure ulcers. J Clin Nurs, 17（15）： 1963-1972, 2008. Review.（Level I） References 2）Ohura T, Iwasawa A, Kiryu M, et al：Effect of clean- 1）Nagai Y：Topical drug and wound dressing .Jpn J sing byphysiologicalsaline on bacterial counts of PU, 10（ 1 ）：1-9, 2008.（ Level VI ）（ Japanese, En- pressure ulcer. Jpn J PU, 9（ 2 ）：183-191, 2007. glish abstract） （Level IV）（Japanese, English abstract） 2）Furuta K：Selection and technical aspects of topical drugs .Jpn J PU, 11（2）：92-100, 2009.（Level VI） CQ 1. 10：How should pressure ulcers be disin- （Japanese, English abstract） fected? 3）Yoshida K：Tips for pressure ulcer pharmacother- ［ Recommendation ］Wound cleansing is usually apeutics with case reports .Jpn J PU, 12（2）：85-92, adequate to prevent infection. However, if the wound 2010.（Level VI）（Japanese, English abstract） is clearlyinfected or if there is excessive exudate or pus, the wound maybe disinfected using antiseptics CQ 1.9：How should a pressure ulcer be cleaned? prior to cleansing. ［ Recommendation ］Cleanse the pressure ulcer ［Rating］C1 using isotonic saline or tap water in sufficient ［Analysis］A systematic review of various studies quantities to reduce the microbial count on the wound selected bytheir qualityand dealing with the surface. retardative effect of povidone-iodine on wound ［Rating］C1 healing1）, has shown that the majorityof cases ［Analysis］In the one published systematic review arguing against the use of povidone-iodine were either comparing wound cleansing solutions and cleansing in vitro or animal model studies whereas 71% of the techniques1）, pressure ulcers cleaned with isotonic highlyranked human studies supported its use. saline（ VulnopurTM ）containing aloe vera, silver Further, 57% of the studies with the highest impact chloride, or decyl glucoside（ 59 cases ）showed a factor supported its use as an antiseptic. There are demonstrable improvement in their PSST（Pressure onlyscantydata regarding the relationship between Sore Status Tool）scores（P ＝ 0.025）compared to symptoms of infection and retardation of healing due those cleaned onlywith isotonic saline（74 cases）. to use of antiseptics and it is not at all clear that No significant difference was noted in the PSST povidone-iodine has a toxic or retardative effect on score of pressure ulcers cleaned with either isotonic wound healing. saline only（four cases）or with tap water only（four The 1994 AHCPR guidelines2） claim that lavation cases）. With regard to the cleansing techniques, no with isotonic saline is sufficient for cleansing infected significant difference was noted in treatment effect pressure ulcers and that cleansing solutions and between the so-called\ whirlpool Smethod（ 24 antiseptics are unnecessary. On the other hand, the cases）and more conventional lavation（18 cases）.Of EPUAP guidelines of 1999 3）state that use of antisep- the 36 cases featured in one comparative case report2） tics is indicated in cases in which there are clear signs 6 out of 19 cases cleaned with 50 ml isotonic saline and of infection and abnormallylarge amounts of exudates 5 out of 29 cases cleaned with 100 ml isotonic saline or pus. demonstrated an increase in microbial count, whereas In summary, even at the wound stage at which no increase in microbial count was observed in anyof debridement and infection control are normallycalled

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for, cleansing with isotonic saline or tap water is ointment, and iodoform, there is as yet little evidence sufficient in most cases. However, in cases in which 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-trypsin, povidone-iodine, iodine ointment, and tion impairment when using a formulation of PVP-I iodoform maybe used for treatment on a dailybasis. antiseptic on open wounds?. Dermatology, 212 Suppl References 1：66-76, 2006.（Level I） 2）Bergstrom N, Allman RM, Alvarez OM, et al：Treat- 1 ）lshibashi Y, Ohkawara A, Kukita A, et al：Clinical ment of Pressure Ulcers Clinical Practice Guidelines evaluation of NI-009 on various cutaneous ulcers. Number 15, No95-0652,US Department of Health and Comparative studyof Debrisan. J Clin Ther Med,6 Human Services, Public Health Service, Agencyfor （4）：785-816, 1990.（Level II）（Japanese） Health Care Policyand Research. AHCPR Publication, 2）Yura J, Ando M, Ishikawa S, et al：Clinical evaluation Rockville Maryland, 1994. of silver sulfadiazine（ T107 ）in the treatment of 3）European Pressure Ulcer AdvisoryPanel: Pressure decubitus ulcer or chronic dermal ulcers: Double- ulcer treatment guidelines. EPUAP business office, blind studyincluding placebo. Chemotherapy,32： Oxford, 1999. 208-222, 1984.（Level II）（Japanese） 3）lmamura S, Uchino H, Imura Y, et al：The clinical CQ 1.11：Which topical agents are recommended effect of KT-136（ sugar and povidone-iodine oint- for pressure ulcers accompanied byinfection and ment ）on decubitus ulcers: A comparative study inflammation? with lysozyme ointment. Jpn Pharmacol Ther, 17 ［Recommendation］ （Suppl.1）：255-280, 1989.（Level II）（Japanese） 1. Cadexomer-iodine, silver sulfadiazine, and povidone-iodine sugar are recommended for their CQ 1.12：Which topical agents are recommended to abilityto control infections. accelerate granulation formation in pressure ulcers ［Rataing］B with deficient granulation formation? 2. Fradiomycin sulfate-trypsin, povidone-iodine, ［Recommendation］ iodine ointment, and iodoform gauze maybe consi- 1. Aluminium chlorohydroxy allantoinate, dered. trafermin, tretinoin tocoferil and povidone-iodine ［Rating］C1 sugar, all of which are known to accelerate granula- ［Analysis］A randomized controlled trial with 60 tion formation, are recommended. subjects comparing cadexomer-iodine with dextra- ［Rating］B nomer demonstrated significant decreases in levels of 2. Alprostadil alfadex, bucladesine sodium, or pus（p ＜ 0.05）1）, one of the assessment categories in lysozyme hydrochloride may be considered. the study, following treatment with cadexomer-iodine. ［Rating］C1 Another randomized controlled trial comparing ［Analysis］Aluminium chlorohydroxy allantoinate: silver sulfadiazine with a placebo group（ total 77 One studyof the effect of aluminium chlorohydroxy subjects）reported a significant anti-microbial effect allantoinate on the acceleration of granulation forma- （p ＜ 0.01）in 64.7% and 27% of the subjects, respec- tion involved a randomized controlled trial using tively. In an open randomized controlled trial compar- solcoseryl（extract from hemolyzed blood of young ing povidone-iodine sugar with lysozome hydrochlor- calves ）1）. The results for each of the 27 subjects ide involving 141 subjects, 32. 8% and 14. 8% of the enrolled showed a significantlygreater increase in subjects, respectively, reported a significant improve- granulation formation when compared with the ment in microbial infection rate（p ＜ 0.05）3）.Onthe control group. other hand, while there are case reports concerning Trafermin: Although a randomized controlled trial fradiomycin sulfate-trypsin, povidone-iodine, iodine comparing the efficacyof trafermin with that of

―G−22― ―34― povidone-iodine sugar, GM-CSF and low concentration there is a significant difference between these agents of fibroblast growth factor in reducing wound size in their abilityto accelerate granulation formation. does exist2−5）, the data on granulation formation are In summary, the evidence level indicated in the not shown. However, one historical controlled trial6） previous edition of the guidelines has been modified has reported a significantlygreater granulation and one medication has been added to the list of formation effect for trafermin in comparison with the recommendations on the basis of the above considera- control. The studyfurther reported that trafermin tions. The determination of which topical agents to was especiallyefficacious when administered in the use in a given situation calls for an assessment of the earlystages of treatment and enhanced the treatment properties of each topical agent and the condition of effect. Although the evidence level for trafermin is IV, the wound in question. this medication merits recommendation on the basis References of case series reports documenting its efficacyas well as the expert opinions given in its favor7, 8）. 1）Mizutani H, Ootsuki T, Matsumoto H, et al：Clinical Tretinoin tocoferil: In the two existing open effects of topical aluminum chlorhydroxy allantoinate randomized controlled trials comparing the granula- on pressure ulcers: A comparative studyof solcoseryl tion formation effect of tretinoin tocoferil with that of ointment. Jp J Clin Exp Med, 59（6）：097-2112, 1982. lysozyme hydrochloride and bendazac ointment9, 10）, （Level II）（Japanese） tretinoin tocoferil was observed to have a significantly 2 ）Ishibashi Y, Soeda S, Ohura T：Clinical effects of greater effect than either of the controls. KCB-1, a solution of recombinant human basic Povidone-iodine sugar: An open randomized trial fibroblast growth factor, on skin ulcers: A phase III comparing povidone-iodine sugar with lysozyme studywith comparisons to sugar and povidone iodine hydrochloride reported a superior granulation forma- ointment. J Clin Ther Med,12（10）：2159-2187, 1996. tion effect for lysozyme hydrochloride than for （Level II）（Japanese） povidone-iodine sugar11）. 3）Martin CR：Sequential cytokine therapy for pressure Alprostadil alfadex: Although there is a randomized ulcers, clinical and mechanistic response. Ann Surg, trial comparing the wound reduction effect of 231：600-611, 2000.（Level II） alprostadil alfadex with that of lysozyme 4）Ishibashi Y, Soeda S, Ohura T：The clinical effects of hydrochloride12）with the exception of expert opinion, KCB-1 on skin ulcers: A double blind trial to there are no studies attesting to the granulation determine optimal dosage. J Clin Ther Med, 12（9）： formation effect of alprostadil alfadex. 1809-1834, 1996.（Level II）（Japanese） Bucladesine sodium：At present two random 5 ）Robson MC, Phillips LG, Lawrence WT, et al: The controlled trials exist comparing the effect of buc- safetyand effect of topicallyapplied recombinant ladesine sodium, lysozome hydrochloride, and macro- basic fibroblast growth factor on the healing of gol ointment on accelerating granulation formation. In chronic pressure sores. Ann Surg, 216（4）: 401-408, both reports, bucladesine sodium reportedlyshowed 1992.（Level II） an accelerative effect equal to that of lysozome 6）Ohura T, Nakajyo T, Moriguchi T：Clinical efficacy hydrochloride, but significantly greater than that of of bFGF on pressure ulcers: A case controlled study macrogol ointment13, 14）. However, at present there are employing a new method for evaluation. Jp J PU, 6 no studies documenting its effect on granulation （1）：23-34, 2004.（ Level IV ）（ Japanese, English formation. abstract） Lysozome hydrochloride：Two open randomized 7）Furuta K, Miura H, Endo T：Clinical effects of fiblast trials have been conducted comparing lysozome sprayon pressure ulcers. Jp J Clin Exp Med, 80（7）： hydrochloride with bendazac ointment（ evidence 187-194, 2003.（Level V）（Japanese） level II ）15）. In addition, there are currentlytwo 8）Ishibashi Y, Harada S, Takemura T: Clinical effects of randomized trials comparing lysozome hydrochloride KCB-1（ bFGF ）on skin ulcers, Clinical trial for 12 with povidone-iodine or lysozome hydrochloride weeks. J Clin Ther Med, 12：2117-2129, 1996.（Level containing povidone-iodine sugar16, 17）, although no V）（Japanese） studyhas yetbeen conducted to determine whether 9）L-300 clinical trial studygroup: Controlled compara-

―G−23― ―35―

tive study of the effect of L-300 and lysozyme ointment, povidone-iodine sugar, iodine ointment, or hydrochloride on skin ulcers. J Clin Ther Med, 7： silver sulfadiazine maybe used. 654-665, 1991.（Level II）（Japanese） ［Rating］C1 10）L-300 clinical trial studygroup：Clinical evaluation of ［Analysis］Although critical colonization is a seri- L-300 ointment for treatment of skin ulcers: A ous pathological condition which has the potential to controlled comparative studyusing bendazac oint- delaywound recoveryin pressure ulcers, there are as ment as a control. J Clin Therap Med, 7（ 2 ）： yet no controlled studies dealing specifically with this 437-456, 1991.（Level II）（Japanese） condition. Further, although two case studies exist 11）Imamura S, Uchino H, Imura H, et al：The clinical which mention the anti-microbial effect of iodine effect of KT-136（ sugar and povidone-iodine oint- ointment1, 2） and one evidence level III report which ment ）on decubitus ulcers: A comparative study compares the effect of cadexomer-iodine ointment and using lysozyme ointment. Jpn Pharmacol Ther, 17 povidone-iodine sugar, onlyone studydeals specifical- （Suppl.1）：255-280, 1989.（Level II）（Japanese） lywith pressure ulcers 3）. 12）Imamura S, Sagami S, Ishibashi Y：Clinical studyof The use of the above-mentioned topical agents is prostaglandin E1 ointment（ G-511 Ointment ）in recommended on the basis of the case studies chronic skin ulcers. Well-controlled comparative mentioned as well as expert opinion4−6）. study with lysozyme chloride ointment. J Clin Ther References Med, 10：127-147, 1994.（Level II）（Japanese） 13）Niimura M, Ishibashi Y, Imamura S，et al：Clinical 1）Nagai Y, Amano H, Okada E, et al：Clinical effects of study of the effect of dibutyryl cyclic AMP ointment iodine ointment 0.9% on pressure ulcers. J New Rem （ DT-5621 ）on chronic skin ulcers. Well-controlled & Clin, 59：1215-1223, 2010.（Level V）（Japanese） comparative study with lysozyme ointment. J Clin 2 ）Tachibana T, Fujii N, Wakabayashi M, et al： Ther Med, 7（ 3 ）：677-692, 1991.（ Level II ） Therapeutic effect of 0.9% iodine-containing ointment （Japanese） on yellow-stage of pressure ulcers. Jpn J PU, 12： 14）Niimura M, Yamamoto K, Kishimoto S, et al：Clinical 513-519, 2010.（ Level V ）（ Japanese, English ab- study of the effect of dibutyryl cyclic AMP ointment stract） （ DT-5621 ）on chronic skin ulcers. Jpn Pharmacol 3）Takagi S, Makino T, Kosaka M, et al：Comparison of Ther, 18：2757-2770, 1990.（Level II）（Japanese） the antibacterial effects of two iodine-containing 15）KH101 studygroup：Clinical studyof the effect of antiseptics．Jpn J PU, 11（4）：528-532, 2009.（Level KH101（ Reflap ointment ）on chronic skin ulcers． III）（Japanese, English abstract） Nishinihon J Dermatol, 48（ 3 ）：553-562, 1986. 4）Imamura S：Efficacyand safetyin chronic adminis- （Level II）（Japanese, English abstract） tration of white sugar and povidone-iodine phar- 16 ）Syukuwa T, Okada S, Tukazaki N：The effects of maceuticals（ U-pasta Kowa ）for decubitus. Acta therapy combining lysozyme ointment（Reflap oint- Dermatologica, 89：727-735, 1994.（ Level V ） ment ）and povidone iodine sugar ointment on （Japanese） decubitus．Skin, 32（4）：564-573, 1990.（Level IV） 5 ）Tachibana T：Critical colonization. Jan J Clin Der- （Japanese） matol, 63：42-46, 2009.（Level VI）（Japanese） 17）Miyauchi H, Shimada T, Sikai T, et al：Comparative 6）Tachi M: Management of chronic wound infection． studyon the treatment of decubitus using three Jpn J PU, 11（ 2 ）：101-104, 2009.（ Level VI ） ointments: Reflap, povidone iodine sugar, and their （Japanese, English abstract） combination. Skin, 32（ 4 ）：547-563, 1989.（ Level IV）（Japanese） CQ 1.14：Which topical agents are recommended for wound reduction in pressure ulcers with sufficient CQ 1.13：Which topical agents are recommended in granulation formation? pressure ulcers with deficient granulation formation ［Recommendation］ and suspected critical colonization? 1. Alprostadil alfadex, aluminum chlorohydroxy ［ Recommendation ］Topical medications with an allantoinate, trafermin, bucladesine sodium, and anti-microbial properties, such as cadexomer-iodine povidone-iodine sugar are recommended.

―G−24― ―36―

［Rating］B study with lysozyme chloride ointment. J Clin Ther 2. Zinc oxides, dimethyl isopropylazulene, extract Med, 10：127-147, 1994.（Level II）（Japanese） from hemolyzed blood of young calves, and lysozyme 2）Mizutani H, Ootsuki T, Matsumoto H, et al：Clinical hydrochloride may be used. evaluation of Aluminum chlorohydroxy allantoinate ［Rating］C1 powder（ ISP ）in patients with pressure ulcers: A ［ Analysis ］An open randomized trial with 44 comparison with Solcoseryl ointment. Jp J Clin Exp subjects comparing alprostadil alfadex and lysozyme Med, 59：2097-2112, 1982.（Level II）（Japanese） hydrochloride found that treatment with the former 3）Robson MC, Phillips LG, Lawrence WT, et al：The resulted in a significantlygreater reduction ratio in safetyand effect of topicallyapplied recombinant wound size（p ＜ 0.05）1）. basic fibroblast growth factor on the healing of Similarly, an open randomized trial with 54 subjects chronic pressure sores. Ann Surg, 216（4）：401-408, comparing aluminum chlorohydroxy allantoinate and 1992.（Level II） ointment containing extract from the hemolyzed 4）Niimura M, Yamamoto K, Kishimoto S, et al：Clinical blood of calves found that treatment with the former evaluation of DT-5621 in patients with chronic skin resulted in a significantlygreater reduction in wound ulcer: A multicenter, placebo-controlled double blind size（p ＜ 0.05）2）. Trafermin produced a significantly study. Jpn Pharmacol Ther, 18（7）：2757-2770, 1990. greater reduction in wound size ratio（ p ＜ 0. 05 ） （Level II）（Japanese） when compared with a placebo in an open randomized 5）Ishibashi Y, Soeda S, Ohura T, et al：Clinical effects of trial（n = 119）3）. A randomized controlled trial com- KCB-1, a solution of recombinant human basic paring bucladesine sodium and macrogol（ n = 91 ） fibroblast growth factor, on skin ulcers: A phase III showed that treatment with the former resulted in a studywith comparison to sugar and povidone iodine significantlygreater（p ＜ 0.05）reduction in wound ointment. J Clin Ther Med, 12（10）：2159-2189, 1996. size4）. A randomized controlled trial comparing （Level II）（Japanese） povidone-iodine sugar and trafermin（ n = 63 ） 6 ）Niimura M, lshibashi Y, lmamura S, et al：Clinical showed that both agents produced an equal reduction study of dibutyryl cyclic AMP ointment（DT-5621） in wound size. Similarly, a randomized controlled trial on chronic skin ulcers. Well-controlled comparative （ n = 68 ）comparing lysozyme hydrochloride with study with lysozyme ointment. J Clin Ther Med, 7 bucladesine sodium resulted in equal wound size （3）：667-692, 1991.（Level II）（Japanese） reduction ratio6）. However, it is unclear whether or not the percentage of wound size reduction was CQ1.15：Which topical agents are recommended if measured following adequate granulation formation. necrotic tissue is observed? In view of the wound treatment process, in actual ［Recommendation］Cadexomer-iodine, silver sulfa- clinical practice it is advisable to assess epithelializa- diazine, dextranomer, bromelain tion after sufficient granulation formation has been or povidone-iodine sugar maybe considered. confirmed. ［Rating］C1 In view of the information given above and the ［ Analysis ］The wound debridement efficacy of actual conditions of clinical practice, alprostadil cadexomer-iodine, fibrinolysin-deoxyribonuclease, de- alfadex, aluminum chlorohydroxy allantoinate, xtranomer, and dextrin polymer（ base ）has been trafermin, bucladesine sodium, and povidone-iodine documented in a controlled studywhich reported a sugar are recommended for reducing wound size. significantlygreater improvement rate（p ＞ 0.01）of Zinc oxide, dimethylisopropylazulen, extract from 45. 5% for cadexomer-iodine in comparison with hemolyzed blood of young calves, or lysozyme fibrinolysin-deoxyribonuclease（18.8%）1）. A compari- hydrochloride may also be used. son of cadexomer-iodine with dextranomer showed an efficacyrate of 71.4% and 45.5%, respectively,with no References significant difference observed between these two 1 ）Imamura S, Sagami S, Ishibashi Y, et al：Clinical agents2）. Likewise a comparison of dextrin polymer studyof prostaglandin E1 ointment（G-511 ointment） （base）showed an efficacyrate of 8.3% and 26.7%, in chronic skin ulcers. Well-controlled comparative respectively, and no significant difference between

―G−25― ―37― the two was observed3）. cutaneous ulcers: Comparative studywith base. J Clin At present the use of silver sulfadiazine for wound Ther Med, 5（ 12 ）：2585-2612, 1989.（ Level II ） debridement is endorsed onlybyexpert opinion. As （Japanese） yet there are no studies endorsing its use for this 4）Tachibana T, Miyachi Y：Drug therapy. Jpn J Plast purpose. Surg, 46（5）: 459-470, 2003.（Level VI）（Japanese） The abilityof the emulsion base to penetrate the 5）Horio T, Kawai S, Moriguchi T, et al：Therapeutic skin and to soften and fuse necrotic tissue largely effects of SK-P-9701（dextranomer paste）on press- accounts for the wound-cleaning effects of silver ure ulcers. Jpn J PU, 3（3）：355-364, 2001.（Level sulfadiazine4）. V）（Japanese, English abstract） A case report comparing the effectiveness of 6）Ogawa Y, Kurooka S, Katakami S, et al：The evalu- dextranomer with that of bromelain in debriding ation of the effect of bromelain ointment on the necrotic tissue indicated a reduction in the number of debridement of eschar in burn, decubitus and various cases of tissue necrosis from six cases to one5）. wound. J New Rem & Clin, 48（10）：1301-1309, 1999. Two separate studies have reported a moderate to （Level V）（Japanese） high level of wound debridement efficacyof 57% and 7）Kawai S：Report on the clinical experience of using 72.5% for bromelain6, 7）. bromelain ointment on pressure ulcers. J New Rem The first of two controlled trials comparing the Clin, 52（8）：1210-1216, 2003.（Level V）（Japanese） wound debridement efficacyof povidone-iodine sugar 8）Imamura S, Uchino H, Imura Y, et al：The clinical and lysozome hydrochloride showed a 41.7% efficacy effect of KT-136（ sugar and povidone-iodine oint- rate for povidone-iodine sugar and 66.7% for lysozome ment）on decubitus and skin, ulcers: A comparison hydrochloride ointment8）. The second controlled trial with lysozyme ointment. Jpn Pharmacol Ther, 17 of povidone-iodine sugar with lysozome hydrochloride （1）：255-279, 1989.（Level II）（Japanese） indicated an efficacyrate of 34. 2% and 31. 1%, 9 ）KT-136 Skin Ulcers Comparative StudyGroup： respectively9）. A similar studycomparing ointment Comparative clinical studyof sugar and povidone- containing extract from hemolyzed blood of young iodine ointment（KT-136）and solcoseryl ointment calves with povidone-iodine sugar indicated an （ SS-094 Ointment ）. Jpn Pharmacol Ther, 17（ 4 ）： efficacyrate of 12.5% for the latter, and 23.1% for the 1789-1813, 1994.（Level II）（Japanese） former. No significant difference was observed10）. 10 ）Saito Y, Furuse Y, Ishii T, et al：A clinical rando- Further, a retrospective studyof cases showing a mized comparative stydy of povidone-iodine-sugar reduction in DESIGN scores following povidone- ointment（ U-PASTA KOWA ）versus combined iodine sugar treatment failed to indicate anycorrela- ointment with lysozyme hydrochloride ointment tion between tissue debridement and decrease in （ REFLAP Ointment ）and povidone-iodine-sugar DESIGN score11）. ointment（ U-PASTA KOWA ）on decubitus. Jpn In summary, cadexomer-iodine, sufadiazine silver, Pharmacol Ther, 22（ 5 ）：2403-2413, 1994.（ Level dextranomer, bromelain, and povidone-iodine sugar II）（Japanese） are assigned a recommendation rating of C1. 11）Kobayashi A, Muto S, Chino K, et al：Analysis of the therapeutic effectiveness of a topical agent in the References treatment of pressure ulcers using DESIGN Tool. Jpn 1）Kukita A, Ohura T, Aoki T, et al：Clinical evaluation J PU, 10（2）：111-116, 2008.（Level V）（Japanese, of NI-009 on various cutaneous ulcers: Comparative English abstract） studywith Elase-C Ointment. J Clin Ther Med, 6 （4）：817-848, 1990.（Level II）（Japanese） CQ 1.16：Which topical agents are recommended 2）Ishibashi Y, Ohkawara A, Kukita A, et al：Clinical when undermining has occurred? evaluation of NI-009 on various cutaneous ulcers: ［ Recommedation ］If the undermining is covered Comparative studywith Debrisan. J Clin Ther Med, 6 bynecrotic tissue, the wound surfaces should first be （4）：785-816, 1990.（Level II）（Japanese） cleaned. Also, if there is excessive exudate, povidone 3）Anzai T, Shiratori A, Ohtomo E, et al：Evaluation of iodine-sugar maybe used. If the amount of exudation clinical utilityof NI-009 in the treatment of various is minimal, consider using trafermin or tretinoin

―G−26― ―38― tocoferil. determine the cause of acute phase pressure ulcers. ［Rating］C1 Since the condition of tissue localized in and around ［Analysis］There are a limited number of refer- acute phase pressure ulcers has a propensityto ences dealing with the application of topical agents on worsen rapidly, frequent and regular monitoring of pressure ulcers which list undermining among their the wound condition is vital. For this reason, a assessment categories. In general, however, in cases transparent dressing which will allow visual monitor- in which a undermining is found, all necrotic tissue ing is recommended. should be removed from its interior and the wound Transparent film dressings are recommended for surface cleansed. Caution needs to be exercised to the protection of erythematous areas from friction or prevent the occasional secondaryinfection. shear. Before applying the transparent film dressing, A case-series on the efficacyof povidone-iodine cleanse the skin where the dressing is to be applied. If sugar with undermining as one of its evaluation items there are anynoticeable changes to the wound has demonstrated the ameliorative effect of the condition, replace the dressing with a new one. As a compound1）. rule dressings should be changed at a frequencyof Although a case-control studywith an evidence once per week. level of IV examining the effect of trafermin on References undermining has demonstrated an ameliorative effect, the results were not significantlydifferent from that 1 ）Kawakami S, Shimada K：The treatment of acute of the comparison group2）. phase pressure ulcer. Modern Physician, 28（ 4 ）： At present, the use of tretinoin tocoferil is endorsed 506-507, 2008.（Level VI）（Japanese） onlybyan expert opinion. In summary, povidone-iodine sugar is indicated for CQ 2.2：Which dressings are indicated in pressure the treatment of cases with excessive exudate, while ulcers with suspected deep tissue injury（DTI）? tretinoin tocoferil is indicated for cases with low ［Recommendation］In order to protect the wound amounts of exudate. surface while allowing dailymonitoring of the condition, either transparent film dressings or dres- References sings designed to treat dermal wounds maybe 1 ）Miyachi Y, Kawamori R：Pressure ulcers compli- considered. cated bydiabetes mellitus: Evaluation of U-PASTA ［Rating］C1 KOWA ointment on skin ulcers. Acta Dermatologica, ［ Analysis ］There are no studies examining the 93：239-248, 1998.（Level V）（Japanese） efficacyof dressings on the treatment of deep tissue 2）Robson MC, Phillips LG, Lawrence WT, et al：The injuries（DTI）. Because DTI tends to progress more safetyand effect of topicallyapplied recombinant deeplyinto underlyingtissue, frequent monitoring of basic fibroblast growth factor on the healing of the wound is vital. For this reason, a transparent chronic pressure sores. Ann Surg, 216（4）：401-408, dressing that will allow observation of the wound 1992.（Level II） condition is recommended. Transparent film dres- sings are recommended for the protection of erythe- CQ 2 Dressings matous areas from friction or shear. Before applying CQ 2.1：Which dressings are recommended to treat the polyurethane dressing, cleanse the skin where the acute pressure ulcers? dressing is to be applied. If there are anynoticeable ［Recommendation］In order to protect the wound changes in the condition of the wound, replace the surface while allowing dailymonitoring of the dressing with a new one. As a rule dressings should be condition, transparent film dressings or dressings changed at a frequencyof once per week. designed to treat dermal wounds maybe used. ［Rating］C1 CQ 2. 3：Which dressings are recommended for ［Analysis］Recommendations for the use of dres- pressure ulcers involving redness/purpura? sings to treat acute phase pressure ulcers are ［Recommendation］In order to protect the wound supported onlybyexpert opinion 1）. It is important to surface while allowing dailymonitoring of the

―G−27― ―39― 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 treatment of redness. However, these case reports do local treatment of pressure ulcers. Miyachi Y, Sanada not deal specificallywith pressure ulcers with the H ed, 145-149, Medical Review Co., Ltd, Tokyo, 2007. redness/purpura, but also include discussion of （Level 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 dressing The dressing should be changed at a frequencyof used to treat dermal wounds is recommended. A once per week. Continue visual monitoring of the hydrocolloid dressing used to treat subcutaneous redness or purpura through the dressing. If the tissue wounds is also an option, but is not covered byhealth damage progressed from the epidermis to the dermis, insurance. change treatment for erosion or shallow ulcers. Again, ［Rating］B in order to ensure that these steps can be taken when ［Recommendation］ necessary, a transparent dressing which allows visual 2. Health insurance-covered dressings designed to monitoring is highlyrecommended. treat dermal wounds, such as hydrogel, polyurethane foam sheets, alginate foam dressing, and chitin References membrane maybe considered. Dressings designed to 1 ）Itou T, Takahashi R, Suzuki C, et al：The use of treat subcutaneous wounds, such as hydrogel, hyd- hydrocolloid dressing in the treatment of pressure ropolymer, polyurethane foam, polyurethane foam/ ulcer. Jpn J Nur Sci, 20（12）：75-80, 1995.（Level V） soft silicone, alginate, and chitin membrane can also be （Japanese） employed with equal effect, but are not covered by health insurance. CQ 2. 4：Which dressings are recommended for ［Rating］C1 cases involving blistering? ［Analysis］ ［Recommendation］While leaving the blisters in- ・Hydrocolloid: One systematic review1） and one tact, consider using a transparent film dressing to meta-analysis2）have examined the use of hydrocolloid protect the wound surface. A dressing for dermal for the topical treatment of pressure ulcers. The wounds that allows observation mayalso be consi- systematic review compared hydrocolloid to wet-to- dered. moist saline gauze dressings and found hydrocolloids ［Rating］C1 to be superior to the latter in terms of wound size ［ Analysis ］The use of dressings for blisters is reduction, absorption of exudates, frequencyof supported onlybyexpert opinion 1）. A transparent replacement, pain felt when dressing is changed, side film dressing is recommended for the protection of effects, and cost. However, because stage III pressure blistering areas from friction or shear. Before applying ulcers are included in the study, the specific relevance the transparent film dressing, cleanse the skin where of the findings to erosions and shallow ulcers remains the dressing is to be applied. As a rule dressings unclear. The meta-analysis2） found hydrocolloid 72% should be changed at least once per week. If the more effective（ odds ratio: 1. 72 ）than wet-to-moist blisters are tense, theymaybe punctured and drained gauze or paraffin-gauze dressings, but omits any to relieve pressure1）. If the blisters are ruptured and discussion of the depth of the wounds observed in the the wound begins to penetrate to the dermis, switch study. Because the specific relevance of these results to a treatment for erosion or shallow ulcers. Again, in to erosions and shallow ulcers is not clear, the

―G−28― ―40― methods described here have been assigned the matic review of the use of hydorocolloids in the recommendation rating of B. treatment of pressure ulcers. J Clin Nurs, 17（9）： ・Hydrogel: Two randomized controlled trials have 1164-1173, 2008.（Level I） examined the healing rate following use of various 2）Singh A, Haler S, Menon GR, et al：Meta-analysis of dressings3, 4）. These studies found no significant randomized controlled trials on hydrocolloid occlusive difference in efficacybetween wet-to-moist gauze dressing vs conventional gauze dressing in the dressings and hydrocolloids. Furthermore, as the healing of chronic wounds. Asian J Surg, 27（ 4 ）： studyincluded stage III and IV pressure ulcers, the 326-332, 2004.（Level I） specific relevance of the findings to cases of erosions 3）Mulder GD, Altman M, SeeleyJE, et al：Prospective and shallow ulcers remains unclear. For this reason, randomized studyof the efficacyof hydrogel, the methods discussed here have been assigned the hydrocolloid, and saline solution-moistened dressings recommendation rating of C1. on the management of pressure ulcers. Wound Repair ・Hydropolymer: One randomized controlled trial5） Regen, 1（4）：213-218, 1993.（Level II） examined the efficacy of hydropolymer on healing 4）Thomas DR, Goode PS, LaMaster K, et al：Aceman- rate. In a comparison of hydropolymer with hydrocol- nan hydrogel dressing versus saline dressing for loid using stage II and III pressure ulcers, the study pressure ulcers. Adv Wound Care, 11（6）：273-276, found no significant difference in healing time or 1998.（Level II） healing rate. As the studywas designed as a 5）Thomas S, Banks V, Bale S, et al：A comparison of superioritytrial, we cannot be certain that the efficacy two dressings in the management of chronic wounds. of the hydropolymer was equal to that of the J Wound Care, 6（8）：383-386, 1997.（Level II） hydrocolloid. 6）Payne WG, Posnett J, Alvarez O, et al：A prospective, For this reason the methods discussed here have randomized clinical trial to assess the cost- been assigned the recommendation rating of C1. effectiveness of a modern foam dressing versus a ・Polyurethane foam: A randomized controlled traditional saline gauze dressing in the treatment of trial6） comparing the healing rate for stage II pressure stage II pressure ulcers. OstomyWound Manage, 55 ulcers treated with saline gauze dressings or （2）：50-55, 2009.（Level II） polyurethane foam found no significant difference in 7）Maume S, Van De Looverbosch D, Heyman H, et al： the time required for wound closure, but the A studyto compare a new self-adherent soft silicone frequencyrequired for changing the dressings was dressing with a self-adherent polymer dressing in significantlylower for polyurethanefoam（ p ＜ stage II pressure ulcers. OstomyWound Manage, 49 0.001）. However, because no significant difference in （9）：44-51, 2003.（Level II） time required for wound closure was found, the methods discussed here have been assigned the CQ 2. 6：Which dressings are recommended for recommendation rating of C1. pressure ulcers involving pain? ・Polyurethane foam/soft silicone: One randomized ［Recommendation］Dressings cannot remove pain controlled trial examined the recoveryrate in stage II but can lessen it byprotecting the wound surface and pressure ulcers after use of polyurethane foam maintaining a moist environment conducive to wound dressings but found no significant difference with the healing. When changing dressings, perform adequate use of hydropolymer dressing7）. For this reason, pain assessment and applya hydrocolloid, polyurethane foam/soft silicone dressing has been polyurethane foam, polyurethane foam/soft silicone, given a recommendation rating of C1. Hydrofiber®, chitin membrane, or hydrogel. ・Alginate foam, chitin membrane, and alginate: No ［Rating］C1 studies addressing the use of these dressings on ［Analysis］ erosions and shallow ulcers exist. Recommendations ・Hydrocolloid: One systematic review1） examines for their use are supported onlybyexpert opinion. the pain associated with pressure ulcers, but does not address the relationship between pain and different References types of dressing. Only one cross-sectional study2） 1）Heyneman A, Beele H, Vanderwee K, et al：A syste- examines this relationship and reports a significantly

―G−29― ―41―

greater efficacyin diminishing pain for hydrocolloid changed9）. However, no statistical data have been than for saline gauze dressings or transparent film offered in the studyto corroborate this claim. dressings（p ＜ 0.02）. For this reason, hydrocolloid *Hydrogel: There are no studies assessing the has been given a recommendation rating of C1 in efficacyof hydrogeldressings in reducing or relieving terms of pain reduction. pain when dressings are being changed. However, its Because pressure ulcers maycause considerable use is endorsed byexpert opinion. pain, adequate pain assessment is required. Because References the pain-reducing properties of the hydrocolloid dressing are most effective within a occlusive or moist 1 ）Pieper B, Langemo D, Cuddigan J：Pressure ulcer environment3, 4）it maybe used to lessen pain experi- pain：A systematic literature review and national enced when dressings are changed. However, when pressure ulcer advisorypanel white paper. Ostomy used on fragile skin, it should be removed with utmost Wound Manage, 55（2）：16-31, 2009.（Level I） care in order to avoid damaging tissue. 2）Dallam L, Smyth C, Jackson BS, et al：Pressure ulcer ・Polyurethane foam: Two randomized controlled pain：assessment and quantification. J Wound trials have examined the pain associated with OstomyContinence Nurs, 22（5）：211-215, 1995. pressure ulcers5, 6）. Of these studies, one compared 3）Hashizume K, Kitaya R, Tsurumi M, et al：Clinical hydrocolloid to polyurethane foam and reported a effect of occlusive dressing Comfeel on decubitus. J significantlylower level of pain associated with New Rem Clin, 46（10）：1348-1360, 1997.（Level V） polyurethane foam when the dressings were changed （Japanese） （p ＜ 0.005）. However, the second study, examining 4）Asakura K, Takahashi R, Suzuki C, et al：Utilityof the pains reported bypatients when saline gauze occlusive dressing Comfeel on decubitus. Jpn J Med dressings and polyurethane film dressings were Pharm Sci, 33（ 1 ）：87-200, 1995.（ Level V ） simultaneouslyused, to the pains reported when （Japanese） polyurethane foam was used, stated that there was no 5）Banks V, Bale S, Harding K：The use of two dress- significant difference between these two groups in ings for moderatelyexuding pressure sores. J Wound terms of the pain or degree of discomfort reported Care, 3（3）：132-134, 1994.（Level II） when the dressings were removed. On these grounds, 6 ）Banks V, Bale S, Harding K：Superficial pressure polyurethane foam has been assigned a recommenda- sores：comparing two regimens. J Wound Care, 3 tion rating of C1. （1）：8-10, 1994.（Level II） ・Polyurethane foam/soft silicone: A case report 7）Hurd T, GregoryJ, Jones A, et al：A multi-centre in- examining the pain associated with the use of various market evaluation of ALLEVYN Gentle Border. types of dressing claimed that 93% of patients treated Wounds UK, 5（3）：32-44, 2009.（Level V） with polyurethane foam/soft silicone dressings ex- 8）Parish LC, Dryjski M, Cadden S, et al：Prospective perienced no pain when the dressings were being clinical studyof a new adhesive gelling foam dressing changed and that all subjects reported satisfaction in pressure ulcers. Int Wound J, 5（1）：60-67, 2008. with the use of this product; recommendation rating （Level V） C1. 9 ）Ueyama T：Treatment of the decubitus by the ・Hydrofiber®: One case report examined the pain flocculent chitin. J New Rem Clin, 43（2）：291-299, associated with pressure ulcers on the basis of results 1994.（Level V）（Japanese） obtained from 23 patients who were treated with Hydrofiber8）. Although the studyfound that CQ 2. 7：Which dressings are recommended in Hydrofiber® was effective in reducing pain 90% or pressure ulcers with excessive exudate? more in stage II〜IV pressure ulcers, no comparison ［Recommendation］ to other types of dressing was included in the study. 1. Recommend using polyurethane foam dressings, Chitin: One case report examined the analgesic which can absorb excess exudates. effect of chitin dressings in 32 patients and found that ［Rating］B of the 19 patients who were successfullyassessed, 15 ［Recommendation］ reported less pain when dressings were being 2. Dressings normallyused for subcutaneous

―G−30― ―42― 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 sys- alginate, alginate foam, chitin membrane, Hydrofiber®, tematic review of the use of hydrocolloids in the or hydropolymer dressings, may be applied. treatment of pressure ulcers. J Clin Nurs, 17（9）： ［Rating］C1 1164-1173, 2008.（Level I） ［ Analysis ］The one systematic review which 2）Bale S, Squires D, Varnon T, et al：A comparison of discusses the use of polyurethane foam dressings does two dressings in pressure sore management. J Wound not mention its efficacyin absorbing exudates as an Care, 6（10）：463-466, 1997.（Level II） outcome. Nonetheless, a randomized controlled trial2） 3）Beele H, Meuleneire F, Nahuys M, et al：A prospec- found that polyurethane foam was significantly more tive randomized open label studyto evaluate the effective（ p ＜ 0. 001 ）in absorbing exudates than potential of a new silver alginate/ carboxymethylcel- hydrocolloids, and for this reason the use of lulose antimicrobial wound dressing to promote polyurethane foam has been assigned the recom- wound healing. Int Wound J, 7（4）：262-270, 2010. mendation rating of B. （Level II） On the other hand, alginate/CMC（carboxymethyl- 4）Maume S, Van De Looverbosch D, Heyman H, et al： cellulose ）, polyurethane foam/soft silicone, alginate, A studyto compare a new self-adherent soft silicone chitin membrane, Hydrofiber®, and hydropolymer, are dressing with a self-adherent polymer dressing in not discussed in anyhigh-evidence level studies and stage II pressure ulcers. OstomyWound Manage, 49 so theyhave been assigned the recommendation （9）：44-51, 2003.（Level II） rating of C1. 5）Harada S, Nakanishi H, Kawabata Y：Clinical Evalua- Beele et al. examined the effect of silver-containing tion of SORBSAN（Calcium alginate fiber dressing） alginate/CMC and non-silver-containing alginate/ for the treatment of skin ulcer. J New Rem Clin, 10 CMC in a randomized controlled trial using 36 （2）：473-495, 1994.（Level V）（Japanese） patients with moderate to high levels of exudates 6）Tsukada K：Usefulness of sponge- type alginate gel from pressure ulcers or varicose ulcers and found dressing on tissue granulation of pressure ulcers. Jpn significantlyhigher level of wound-size reduction in JPU, 5（1）：27-32, 2003.（Level V）（Japanese, En- patients treated with silver-containing alginate dres- glish abstract） sings（p = 0.017）3）. However, due to the fact that this 7）Ueyama T：Treatment of the decubitus by the flo- studyfails to assess the capacityof these dressings to cculent chitin. J New Rem Clin, 43（ 2 ）：291-299, absorb exudates, the methods discussed here have 1994.（Level V）（Japanese） been assigned a recommendation rating of C1. 8）Coutts P, Sibbald R：The effect of a silver-containing A randomized controlled trial4）. compared the Hydrofiber® dressing on superficial wound bed and ability of polyurethane foam/soft silicone and hyd- bacterial balance of chronic wounds. Int Wound J, 2 ropolymer to absorb exudates and found that while （4）：348-356, 2005.（Level V） there was no statistical difference in absorptive 9）Parish LC, Dryjski M, Cadden S：Prospective clinical capacitybetween these two typesof dressing, studyof a new adhesive Gelling foam dressing in polyurethane foam/soft silicone dressings were super- pressure ulcers. Int Wound J, 5（ 1 ）：60-67, 2008. ior in preventing damage and maceration to skin in （Level V） the wound periphery（p ＜ 0.05）. Because there was 10）Ohura T：Clinical experience with a new hydropo- no difference in the absorptive capacityof these lymer dressing. Jpn JPU, 4（ 1 ）：105-110, 2002. dressings, their use has been assigned the recom- （Level V）（Japanese, English abstract） mendation rating of C1. The use of alginate, alginate foam, chitin membrane CQ 2. 8：Which dressings are recommended for Hydrofiber®, and hydropolymer dressings is addres- pressure ulcers with minimal amounts of exudates? sed onlyin case reports; recommendation rating: ［Recommendation］ C15−10）. 1. Using a hydrocolloid dressing is recommended. ［Rating］B

―G−31― ―43―

［Recommendation］ excessive exudates because of its superior absorptive 2. Using a hydrogel may be considered. ability, but cannot be recommended here due to its ［Rating］C1 inabilityto suppress infection. ［Analysis］ ［Rating］C2 ・Hydrocolloid: One meta-analysis exists addressing ［Analysis］One systematic review1）has addressed the use of hydrocolloid dressing for local treatment of the use of silver-containing Hydrofiber® in the context pressure ulcers1）. In this study, hydrocolloid was of wound infection and inflammation. In 26 rando- found to be 72% more effective in healing pressure mized controlled trials dealing with the use of silver in ulcers than conventional saline gauze dressings or the localized treatment of acute phase and chronically paraffin-gauze dressings（odds ratio: 1.72）. However, contaminated and infected wounds failed to detect a as no mention is made of the capacityof each typeof significant difference in the infection rate as an dressing to absorb exudates, the recommendation outcome. Due to this observation, it was concluded 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 efficacyof silver in the treatment of infected wounds, with saline gauze dressings and hydrocolloid dres- Toyand Macera state that there is insufficient sings failed to show a significant difference in this evidence to endorse the use of silver-containing foam regard. While the studydeals with the treatment of dressings to treat chronicallycontaminated and stage II〜IV pressure ulcers, it does not address the infected wounds2）. efficacyof hydrogeldressings for the treatment of Three randomized controlled trials have addressed pressure ulcers with low amounts of exudates and the use of silver alginate to suppress infection in therefore merits a recommendation rating of onlyC1. pressure ulcers3−5）. The studies found that silver- containing alginate/CMC not onlyresulted in a References greater reduction in wound size than non-silver- 1）Singh A, Haler S, Menon GR, et al：Meta-analysis of containing alginate/CMC,（p = 0.017）, but also in a randomized controlled trials on hydrocolloid occlusive significantlybetter healing rate four weeks into dressing vs conventional gauze dressing in the treatment（p = 0.044）. On the basis of these findings, healing of chronic wounds. Asian J Surg, 27（ 4 ）： it was concluded that silver-containing alginate/CMC 326-332, 2004.（Level I） has a significantlygreater effect on promoting healing 2）Thomas DR, Goode PS, LaMaster K, et al：Aceman- in pressure ulcers and suppressing infection. On the nan hydrogel dressing versus saline dressing for other hand, other studies report disparate results, pressure ulcers. Adv Wound Care, 11（6）：273-276, with Trial et al. claiming that a comparison of alginate 1998.（Level II） and silver-containing alginate failed to show any 3）Mulder GD, Altman M, SeeleyJE, et al：Prospective difference in the clinical scores for infection4）, and randomized studyof the efficacyof hydrogel, Meaume et al. claiming that while there was no hydrocolloid, and saline solution-moistened dressings statisticallysignificant difference in wound infection on the management of pressure ulcers. Wound Repair rate after use of silver-containing alginate（33%）and Regen, 1（4）：213-218, 1993.（Level III） alginate（46%）, the healing rate for silver-containing alginate was appreciablyhigher（p = 0.024）5）.Onthe CQ 2. 9：Which dressings are recommended for basis of these findings, silver-containing Hydrofiber® infected and inflamed pressure ulcers? or silver alginate maybe used to treat infected or ［Recommendation］ inflamed wounds. However, when the evidence from 1. Consider using topical agents to suppress the systematic reviews1, 2） is taken into account, it is infection. Alternatively, silver-containing Hydrofiber® clear that the use of these dressings to treat infected or alginate silver maybe used. wounds is not supported byadequate evidence. In ［Rating］C1 addition, because of the unavailabilityin Japan, and 2. Alginate is sometimes used to dress wounds with varying silver content, of some of the products

―G−32― ―44― examined in the aforementioned studies, the abilityof ［ Recommendation ］Alginate, hydrocolloid, hyd- these dressings to suppress infections cannot be ropolymer, polyurethane foam, polyurethane foam/ clearlyassessed. Therefore the methods discussed soft silicone, chitin membrane and Hydrofiber® may here have been assigned the recommendation rating be considered. of C1. ［Rating］C1 Alginate is sometimes used for its superior absorp- ［Analysis］ tive qualities to treat pressure ulcers with large *Alginate: There is one systematic review examin- quantities of exudates. However, as it has no ing the use of silver-containing dressings1） and one demonstrable abilityto suppress infection, its use is randomized controlled studyexamining the use of not recommended. alginate to treat pressure ulcers2）. The systematic One randomized controlled trial examined the use review does not draw anyconclusions regarding the of alginate on infected wounds5）. The studyfound that efficacyof silver-containing dressings in promoting in 71 cases of varicose ulcer and 28 cases of pressure granulation tissue formation, while the randomized ulcer all requiring infection suppression, no difference controlled trial reported that significantlygreater in result was seen in wound infection rate between the reductions in wound size were achieved with the use groups treated with alginate and silver-containing of hydrocolloid following treatment with alginate than alginate5）. On the basis of the reports, we may with the use of hydrocolloid alone（p ＜ 0.01）. Howev- conclude that although alginate is sometimes used for er, as the studydid not examine the effect of using its superior abilityto absorb exudates, it has no alginate alone, the recommendation level merits a demonstrable abilityto suppress wound infection and rating of C1. therefore cannot be recommended. *While there are randomized controlled trials examining the use of hydrocolloid, hydropolymer, References polyurethane foam, and polyurethane foam/soft 1）Storm-Versloot MN, Vos CG, Ubbink DT, et al：Topical silicone, none of these studies reports on the effect of silver for preventing wound infection, Cochrane these dressings on granulation tissue formation; Wounds Group, Cochrane Database of Systematic recommendation level: C1. Reviews 2010, Issue 3. Art.（Level I） *Chitin and Hydrofiber® are addressed onlyin case 2）ToyLW, Macera L：Evidence-based review of silver reports. As the evidence level is low, the recommenda- dressing use on chronic wounds. J Am Acad Nurse tion rating given is C1. Pract, 23（4）：183-192, 2011.（Level I） References 3）Beele H, Meuleneire F, Nahuys M, et al：A prospec- tive randomized open label studyto evaluate the 1）Carter MJ, Tingley-Kelley K, Warriner RA 3rd： potential of a new silver alginate/carboxymethylcel- Silver treatments and silver-impregnated dressings lulose antimicrobial wound dressing to promote for the healing of leg wounds and ulcers：A wound healing. Int Wound J, 7（4）：262-270, 2010. systematic review and meta-analysis. J Am Acad （Level II） Dermatol, 63（4）：668-679, 2010.（Level I） 4）Trial C, Darbas H, Lavigne JP, et al：Assessment of 2）Belmin J, Meaume S, Rabus MT, et al：Investigators the antimicrobial effectiveness of a new silver alginate of the sequential treatment of the elderlywith wound dressing：a RCT. J Wound Care, 19（ 1 ）： pressure sores（STEPS）trial. Sequential treatment 20-26, 2010.（Level II） with calcium alginate dressings and hydrocolloid 5）Meaume S, Vallet D, Morere MN, et al：Evaluation of dressings accelerates pressure ulcer healing in older a silver-releasing hydroalginate dressing in chronic subjects：a multicenter randomized trial of sequen- wounds with signs of local infection. J Wound Care, 14 tial versus nonsequential treatment with hydrocolloid （9）：411-419, 2005.（Level II） dressings alone. J Am Geriatr Soc, 50（2）：269-274, 2002.（Level II） CQ 2. 10：Which dressings are recommended for promoting granulation tissue formation in pressure CQ 2. 11：Which dressings are recommended in ulcers where it is deficient? pressure ulcers with deficient granulation tissue

―G−33― ―45― formation and suspected critical colonization? adequate/normal granulation tissue formation? ［Recommendation］Consider using silver-containing ［Recommendation］ Hydrofiber® or alginate silver. 1. Using silver-containing Hydrofiber®, alginate ［Rating］C1 silver, or alginate is recommended. ［Analysis］A systematic review using indications ［Rating］B of critical colonization as a measure compared the ［Recommendation］ effect of silver-containing Hydrofiber® and other types 2. Hydrocolloid, hydrogel, hydropolymer, of dressing on wound size reduction and healing polyurethane foam, polyurethane foam/soft silicone rate1）. However, this studyfailed to arrive at any dressing, alginate foam, chitin membrane, conclusions regarding pressure ulcers where critical Hydrofiber®, alginate/CMC are also options, depend- colonization was suspected due to insufficient granula- ing on the amount of exudate present. tion tissue formation. Of the randomized controlled ［Rating］C1 trials discussed in the systematic review2）, although ［Analysis］The one systematic review1）examining significant reductions in wound size were reported（p the effect of silver-containing Hydrofiber® concluded = 0. 0019 ）, only8% of the subjects enrolled were that while wound reduction could be achieved in the pressure ulcer patients. There is also one randomized short term, Hydrofiber® could not be recommended controlled trial examining the effect of silver- for promoting wound healing due to the paucityof containing alginate on varicose ulcers requiring infec- evidence; recommendation rating B. tion suppression and pressure ulcers. In a comparison In their randomized controlled trial, Beale et al. of silver-containing alginate and non-silver-containing reported the efficacyof silver alginate on wound-size alginate on 24 cases of varicose ulcer in the critical reduction, but their comparison of silver-containing colonization phase or at risk of infection and 12 cases alginate/CMC and non-silver-containing alginate/ of pressure ulcer, the studyfound that while there CMC concluded that the use of silver-containing was no exacerbation of infection in either group, alginate led to greater reductions in wound size significantlygreater reductions in wound size were compared to alginate alone（p = 0.017）and therefore achieved in the silver-containing alginate group（p = to a stronger wound healing effect2）. On the basis of 0. 017 ）. However, because the number of pressure this conclusion, the use of silver-containing alginate ulcer patients enrolled was small, and no discussion has been assigned a recommendation rating of B. about granulation formation in these cases was Although the wound reduction effect of alginate is included, the methods discussed here have been mentioned in a systematic review by Madhuri et al., assigned a recommendation rating of C1. the studyfailed to offer clear proof of this assertion 3）. In a randomized controlled trial4）, the result of a References comparison of alginate and dextranomer paste found 1）Beam JW：Topical silver for infected wounds. J Athl that wounds treated with alginate showed greater Train, 44（5）：531-533, 2009.（Level I） reduction in size. Further, in an eight-week experi- 2 ）Munter KC, Beele H, Russell L, et al：Effect of a ment one group of subjects was treated with alginate sustained silver-releasing dressing on ulcers with for the first four weeks, then with a combination of delayed healing：the CONTOP study. J Wound Care, alginate and hydrocolloid for the next four weeks. 15（5）：199-206, 2006.（Level II） Another group was treated for eight weeks with 3）Beele H, Meuleneire F, Nahuys M, et al：A prospec- hydrocolloid alone. A comparison of the results tive randomized open label studyto evaluate the indicated greater reductions in wound size for the potential of a new silver alginate/carboxymethylcel- former（p ＜ 0.01）. Accordinglythe methods discus- lulose antimicrobial wound dressing to promote sed here have been given the recommendation rating wound healing. Int Wound J, 7（4）：262-270, 2010. of B. （Level II） On the basis of these reports, consider using silver- containing Hydrofiber®, silver alginate, or alginate CQ 2. 12：Which dressings are recommended to when attempting to achieve wound-size reduction in promote the reduction of the size of wounds with cases with adequate granulation formation.

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A systematic review claiming greater efficacy in 1164-1173, 2008.（Level I） wound-size reduction for hydrocolloid in a comparison with saline gauze dressings5） also states that no CQ 2.13：Which dressings are recommended when significant difference in efficacywas found in a necrotic tissue is present? comparison of hydrocolloid with alginate, hydrogel, ［ Recommendation ］If surgical debridement or and polyurethane foam. For this reason, the use of topical agents capable of removing necrotic tissue are hydrocolloid has been accorded the same recom- unavailable, hydrogel may be considered. mendation rating of C1 as the other types of dressing ［Rating］C1 previouslydiscussed. ［ Analysis ］One randomized controlled trial ex- Although a number of randomized controlled trials amined the use of hydrogel and dextranomer paste in have examined the other types of dressing, including connection with the removal of necrotic tissue and hydrogel, hydropolymer, and polyurethane foam, none reported no significant difference in the rate of of these studies documented evidence pertaining to removal of necrotic tissue for either type of dressing. their efficacyin wound reduction. Polyurethane The recommendation level assigned to these dres- foam/soft silicone, alginate foam, chitin, Hydrofiber®, sings is therefore C1. In addition to these studies, and aliginate/CMC have been discussed in case Parnell et al. have published a case report in which reports only; recommendation rating: C1. hydrogel with endopeptidase was used to treat stage From these reports, anyof the dressings discussed II and III pressure ulcers assessed clinicallyas above, namely hydrocolloid, hydrogel, hydropolymer, infected and requiring removal of necrotic tissue2）. polyurethane foam, polyurethane foam/soft silicone, The stage II and III pressure ulcers which had not alginate foam, chitin, Hydrofiber®, and alginate/CMC been treated for three months prior to commence- can be used according to the amount of exudates. ment of the studyhealed in an average of 3.3 weeks and 6.5 weeks, respectively, but the effect of hydrogel References could not be assessed because it was used in 1）Carter MJ, Tingley-Kelley K, Warriner RA, et al： combination with other dressings. Silver treatments and silver-impregnated dressings References for the healing of leg wounds and ulcers：A systematic review and meta-analysis. J Am Acad 1 ）Colin D, Kurring PA, Yvon C：Managing sloughy Dermatol, 63（4）：668-679, 2010.（Level I） pressure sores. J Wound Care, 5（10）：444-446, 1996. 2）Beele H, Meuleneire F, Nahuys M, et al：A prospec- 2）Parnell LK, Ciufi B, Gokoo CF：Preliminaryuse of a tive randomized open label studyto evaluate the hydrogel containing enzymes in the treatment of potential of a new silver alginate/ carboxymethylcel- stage II and stage III pressure ulcers. OstomyWound lulose antimicrobial wound dressing to promote Manage, 51（8）：50-60, 2005. wound healing. Int Wound J, 7（4）：262-270, 2010. （Level II） CQ 2. 14：Which dressings are recommended if 3 ）Madhuri R, Sudeep S, Rochon P：Treatment of undermining is found? pressure ulcers：A systematic review. JAMA, 300 ［ Recommendation ］If necrotic tissue is present （22）：2647-2662, 2008.（Level I） within the undermining, first remove this through 4 ）Belmin J, Meaume S, Rabus MT, et al：Sequential lavation. If the amount of exudate is excessive, treatment with calcium alginate dressings and consider using alginate, silver-containing Hydrofiber®, hydrocolloid dressings accelerates pressure ulcer or alginate silver. healing in older subjects：A multicenter randomized ［Rating］C1 trial of sequential versus nonsequential treatment ［Analysis］One case report claimed favorable resu- with hydrocolloid dressings alone. J Am Geriatr Soc, lts for the use of alginate inside the undermining, after 50（2）：269-274, 2002.（Level II） granulation formation and reduction in the size of the 5 ）Heyneman A, Beele H, Vanderwee K, et al：A undermining were achieved（Evidence Level V）1）. systematic review of the use of hydrocolloids in the No studies have been published on the efficacyof treatment of pressure ulcers. J Clin Nurs, 17（9）： silver-containing Hydrofiber® and silver alginate

―G−35― ―47― when applied to undermining, and the method is the comparison group across three parameters, the endorsed onlybyexpert opinion（ Evidence Level DESIGN-R score, the PUSH score, and changes in VI ）. When using these dressings inside the wound wound size2）. However, the cost of wrap dressings pocket, care must be taken not to force the dressing was appreciablylower than that of other typesof too deeplyinto the cavityor cause undue pressure on dressing. Further, in a non-randomized controlled trial the surrounding tissue surfaces. If necrotic tissue involving adult patients3）, no difference was recorded remains, prioritize debridement. in midpoint of treatment period for wrap dressings and conventional dressings（p = 0.92）. However, the References dailycost of wrap dressings was significantlylower. In 1）Tsukada K：Usefulness of sponge-type alginate gel all three of these clinical trials there was no difference dressing on tissue granulation of pressure ulcers . Jpn between wrap and other types of dressing in terms of JPU, 5（ 1 ）：27-32, 2003.（ Japanese, English abst- worsening symptoms or deleterious effects. However, ract） one case report4）claimed that there were two cases in which symptoms worsened as a result of the use of CQ 2.15：Is the so-called\wrap dressingS* effec- wrap dressings. tive in treating pressure ulcers? On the basis of the reports discussed above, and in ［Recommendation］Wrap dressings can be consi- accordance with the official position of the 2010 Board dered for use whenever medicallyapproved dressings of the Japan Societyof Pressure Ulcers, the use of are unavailable or difficult to obtain on a continual officiallyapproved dressings is recommended for the basis, such as in a home based medical care. However, treatment of pressure ulcers. As a non-medically use of the wrap dressing should be supervised bya approved item, the wrap dressing maybe considered physician with an adequate knowledge of pressure for use in home based medical care and other settings ulcer care and onlyafter the patients and their family in which the continued use of approved dressings have been instructed in the procedure and given their maybe difficult. However, its use should be supervised consent. bya physicianwith an adequate knowledge of \* Wrap dressing Sis a dressing technique of pressure ulcer care and onlyafter the patients and covering wounds with non-medicallyapproved（un- their familyhave been instructed in the procedure sterilized）and non-adhesive commerciallyavailable and given their consent. plastic wrap. References ［Rating］C1 ［ Analysis ］A comprehensive survey of evidence 1 ）Takahashi J, Yokota O, Fujisawa Y, et al：An pertaining to the\wrapSmethod of dressing wounds evaluation of polywvinylidene film dressing for showed that while there is an abundance of case treatment of pressure ulcers in older people. J Wound reports and comments byspecialists, there is onlyone Care, 15（10）：449-454, 2006.（Level III） 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 study comaring 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 class III〜IV class pressure ulcers（accord- II）（Japanese, English abstract） ing 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.（Level III）（Japanese, English the control dressings, as indicated bythe DESIGN abstract） scores（p = 0.011）1）. The cure rate and the exacerba- 4 ）Moriyama Y：Severe complication associated with tion rate were the same. Furthermore, a randomized inadequate wet dressing therapy:benefits and risks of clinical trial conducted jointlyinvolving NPUAP class so-calledhwrap therapyi. Jpn J Dermatol, 120（11）： II〜II adult pressure ulcer patients found no signifi- 2187-2194, 2010.（ Level V ）（ Japanese, English ab- cant difference in effect between wrap dressings and stract）

―G−36― ―48―

Fig. 3 Algorithm illustrating options for surgical interventions

CQ 3 Surgical Intervention indications for reconstructive surgeryseparately In cases requiring surgical intervention for the from anydiscussion of the condition of the pressure treatment of pressure ulcers, the use of anesthetics, ulcer as a local factor more pertinent to the question of postoperative positioning, and other perioperative whether or not surgical debridement should be matters must be managed with care. The timing and employed. Surgical treatment of undermining is also extent of the surgerywill largelybe determined by addressed in a separate CQ as a factor resistant to the general state of the patientSs physical health as conservative treatment. well as the condition of the specific area targeted for Further, given the fact that even deep ulcers（D3） intervention. do not always require reconstructive surgery but may As indicated in thehAlgorithm on the prevention be treated successfullywith conservative treatments and management of pressure ulcersi（Fig. 1）, surgi- that promote granulation tissue formation to achieve cal intervention is seen as one option for local wound closure, the general topic of surgical treatment treatment of pressure ulcers. has been divided into surgical debridement and Importantly,\ Pressure ulcer present Sin the reconstructive surgeryfor more separate discussion. hAlgorithm on surgical interventioni（Fig. 3）is to In addition, the use of negative pressure wound be understood as referring to patients who have therapy（NPWT）to treat wounds resulting from the alreadyreceived systemiccare and predictive assess- removal of necrotic tissue following surgical debride- ment, but whose existing pressure ulcers have proved ment is considered in CQ in this section. resistant to conservative forms of treatment, such as topical agent and dressing. CQ 3. 1：Is surgical debridement indicated when Determining the optimal area of the pressure ulcer signs of infection/inflammation of the pressure ulcer to be treated with surgical intervention and deciding are present? the best timing for the procedure are often difficult. ［Recommendation］Surgical debridement maybe For this reason, we have decided to discuss the conducted if there is evidence of pus, foul odor, or

―G−37― ―49― osteomyelitis accompanying the infection. 2 ）Galpin JE, Chow AW, Bayer AS, et al：Sepsis ［Rating］C1 associated with decubitus ulcers. Am J Med, 61（3）： ［Analysis］Surgical debridement should be consi- 346-350, 1986.（Evidence level: IV） dered when infected pressure ulcers prove resistant 3 ）National Pressure Ulcer AdvisoryPanel and Euro- to systemic antibiotic administration or topical pean Pressure Ulcer AdvisoryPanel：Surgeryfor antiseptics and dressings. Local abscesses and reten- Pressure Ulcers. Prevention and treatment of press- tion fluid should be lanced and drained to prevent ure ulcers: clinical practice guideline, 96-99, National expansion into surrounding intact tissue and/or Pressure Ulcer AdvisoryPanel, Washington DC, progression to systemic sepsis. 2009. The presence of hardened and thickened necrotic 4）Ratliff CR, Tomaselli N：WOCN update on evidence- tissue（ eschar ）accompanied byfever, local in- based guideline for pressure ulcers. J Wound Ostomy flammation（ redness, swelling, and pain ）, and foul Continence Nurs, 37（5）：459-460, 2010. odor maypoint to an underlyingpus-filled abscess. 5 ）Simpson AH, Deakin M, Latham JM：Chronic For this reason an incision into a portion of the osteomyelitis. The effect of the extent of surgical necrotic tissue is recommended to confirm the resection on infection-free survival. J Bone Joint Surg presence of pus1）. Especiallyin cases in which the Br, 83（3）：403-407, 2001.（Evidence level: IV） nidus of infection in the necrotic tissue has caused sepsis, it is stronglyrecommended that first, the CQ 3.2：What is the optimal timing for the surgical abscess be incised and the sinus and fistula be drained debridement of necrotic tissue in pressure ulcers? as soon as possible, and second, that the necrotic ［Recommendation］ tissue be removed completelyif the patientSs condi- 1. Surgical debridement maybe considered when a tion allows. clear line of demarcation between necrotic and Indeed the efficacyof surgical debridement in healthytissue is visible. controlling infections associated with pressure ulcers ［Rating］C1 has been corroborated bythe findings of a controlled ［Recommendation］ study2）. Furthermore, two guidelines issued by 2. Surgical debridement is considered when pre- NPUAP/ EPUAP3）and WOCN4）assign thehStrength existing infection has been brought under control. of Evidenceirating of C to surgical debridement in ［Rating］C1 the presence of advancing cellulitis, crepitus, fluc- ［Analysis］In cases in which infection has resulted tuance, and/or sepsis secondaryto ulcer-related in tissue necrosis, anyattempt to remove the necrotic infection. The remaining sources dealing with surgical tissue too rapidlymayresult in severe pain and interventions for the treatment of infection are bleeding in the wound margins. Surgical debridement general, textbook descriptions with limited utility. is recommended after the acute phase（ about 3 There are at present no high-level studies dealing weeks）when the demarcation line between necrotic with the efficacyof surgical treatment of osteomyelitis tissue and the surrounding intact tissue has become accompanying pressure ulcers. However, a cohort clear1, 2）. studycomprising 50 cases of osteomyelitisunrelated Necrotic tissue which is allowed to remain within to pressure ulcers has reported a lowered recurrence the wound bed or on the edges of the pressure ulcers rate following wide resectioning of degraded bone mayevolve into a nidus of infection and impede the tissue5）. wound healing process. For this reason, the two guidelines previouslycited recommend not only References surgical but also autolytic, enzymatic, mechanical, or 1）Bergstrom N, Bemet M, Carlson C, et al：Pressure biosurgical（maggot therapy）debridement as treat- ulcer treatment. Clinical practice guideline：Quick ment options1, 2）. reference guide for clinicians. No.15. Rockville, MD： References U. S. Department of Health and Human Services. Public Health Service, Agencyfor Health Care Policy 1）Ratliff CR, Tomaselli N：WOCN update on evidence- and Research. AHCPR Pub, No.95-0653, 1994. based guideline for pressure ulcers. J Wound Ostomy

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Continence Nurs. 2010 Sep-Oct; 37（ 5 ）：459-460. Repair of Pressure Ulcers I： Operation Techniqu. ［ Update of Wound Ostomyand Continence Nurse Jpn JPU, 2（ 3 ）：236-243, 2000.（ Level VI ） Society: Guideline for Prevention and Management of （Japanese, English abstract） Pressure Ulcers. Adv Skin Wound Care, 18（ 4 ）： 3）Kosaka M, Morotomi T, Suzuki H：Selection of per- 204-208, 2005］ forator flaps for sacral pressure ulcers with a 2 ）Bergstorm N, Allman RM, Alvarez MA, et al： subdermal pocket. Jpn JPU, 4（ 3 ）：371-378, 2002. Treatment of Pressure Ulcers Clinical Practice （Level V）（Japanese, English abstract） Guidelines number 15, No95-0652, US Department of Health and Human Services. Public Health Service, CQ 3.4：When is surgical debridement indicated? Agencyfor Health Care Policyand research. AHCPR ［Recommendation］ Publication, Rockville Maryland, 1994.（Level: IV） 1. Conservative treatments are the preferred option, but surgical debridement maybe performed CQ 3.3：Is surgical incision or debridement recom- when infection/inflammatorysigns are under control. mended if undermining is present? ［Rating］C1 ［ Recommendation ］Surgical incision or debride- 2. Surgical debridement maybe considered for ment maybe considered for treating undermining patients with a D3 or D4 pressure ulcer. which fails to respond to more conservative treat- ［Rating］C1 ments. 3. Surgical debridement maybe considered accord- ［Rating］C1 ing to the location of the infected pressure ulcer, the ［Analysis］The presence of undermining raises the volume and extent of the necrotic tissue, the blood possibilityof necrotic tissue underlyingthe formation. supplyto the surrounding tissue, and the patient's In such cases, surgical intervention to lance and drain, level of pain tolerance. or debride, the abscess, sinus tract, or bursa should be ［Ratingl］C1 considered if no improvement results from more ［Analysis］Surgical debridement is generally indi- conservative treatments such as wound cleansing, or cated when the pressure ulcer infection has been application of topical agents. However, a thorough brought under control and the necrotic tissue or systemic assessment should be made, including an degraded granulation tissue fails to respond to assessment of the patientSs propensityto bleed, before conservative treatments. The NPUAP/EPUA and the undermining is incised with the aid of the WOCN guidelines recommendh maintenance de- appropriate tools to stop bleeding1）. In cases of bridementifor the acute phase. pressure ulcers of long duration or with an excep- This form of treatment is indicated for wound stage tionallylarge cavity（DESIGNscore of P3 or higher）, D3 or deeper. Due to the long recoveryperiod surgical incision of the undermining should be required when the pressure ulcer has invaded muscle considered2）. On the other hand, Kosaka et al3）. argue tissue and penetrated to the bone（ D4 ）, surgical that a preoperative incision to the skin overlying the debridement is recommended in order to expedite undermining maylead to scar contracture and recovery3）. hamper reconstructive flap surgery; hence the As indicated above, surgical debridement can prove undermining should be allowed to remain if there is no either too invasive or insufficient. This fact needs to be infection. However, in cases in which surgical considered pre-operativelywhen evaluating the intervention is ruled out, incision of the pocket is still balance of risk and benefit of the procedure to the preferable to onlycontinuing more conservative patient1, 2, 4, 5）. forms of treatment. References References 1）Ratliff CR, Tomaselli N：WOCN update on evidence- 1）WhitneyJ, Phillips L, Aslam R, et al：Guidelines for based guideline for pressure ulcers. J Wound Ostomy the treatment of pressure ulcers. Wound Repair Continence Nurs. 2010 Sep-Oct; 37（ 5 ）：459-460. Regen, 14（6）：663-679, 2006. ［ Update of Wound Ostomyand Continence Nurse 2 ）Nakamura M, Ito M：Slide-swing Plastyfor the Society: Guideline for Prevention and Management of

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Pressure Ulcers. Adv Skin Wound Care, 18（ 4 ）： considered rather than continue a less effective 204-208, 2005］ regimen4）. 2 ）National Pressure Ulcer AdvisoryPanel and Euro- An advancing wound edge fibrosis and scar pean Pressure Ulcer AdvisoryPanel: Debridement. formation surrounding the pressure ulcer are signs of In: DealeyC, Cuddigan J, eds. Prevention and delayed wound healing5）. Debridement of such treatment of pressure ulcers: clinical practice guide- fibrotic/scar tissue typically creates a wound penet- line. 77-80, National Pressure Ulcer AdvisoryPanel, rating beyond the subcutaneous tissue. In such cases, Washington DC, 2009. reconstructive surgeryshould be seriouslyconsi- 3 ）Motegi S：Consideration for Better Treatment of dered, as mentioned above. Pressure Ulcers Based on MyExperienc. Jpn JPU, 2 Surgical removal or sequestrectomyoften leaves a （1）：57-64, 2000.（ Level V ）（ Japanese, English skin defect extending beyond the subcutaneous abstract） tissue. The need for surgical repair should seriously 4）Kurita M, Ichioka S, Oshima Y, et al：Orthopaedic be considered in such cases. POSSUM scoring system: An assessment of the risk References of debridement in patients with pressure sores. Scand J Plast Reconstr Surg Hand Surg, 40（4）：214-218, 1）Kizek TJ, Robson MD,Kho E：Bacterial growth and 2006.（Level: IV） skin graft survival. Surg Forum, 18：518-519, 1967. （Level: I） CQ 3.5：When is reconstructive surgeryindicated? 2）Robson MC, Lea CE, Dalton JB, et al：Quantitative ［Recommendation］ bacteriologyand delayedwound closure. Surg Forum, 1. Reconstructive surgerymaybe considered for 19：501-502, 1968.（Level: I） D3〜D4 pressure ulcers that do not respond to 3 ）Disa JJ, Carlton JM, Goldberg NH：Efficacyof conservative treatment. operative cure in pressure sore patients. Plast ［Rating］C1 Reconstr Surg, 89（2）：272-278, 1992.（Level: IV） 2. Surgical reconstruction maybe considered for 4 ）Motegi S：Consideration for Better Treatment of ulcers showing a non-advancing edge and scar Pressure Ulcers Based on MyExperienc. Jpn JPU, 2 formation. （1）：57-64, 2000.（ Level V ）（ Japanese, English ［Rating］C1 abstract） 3. Reconstructive flap surgeryfollowing sequestra- 5）Ichioka S, Ohura N, Nakatsuka T：Benefits of sur- tion maybe considered as a therapeutic option for gical reconstruction in pressure ulcers with a non- osteomyelitis in pressure ulcers. advancing edge and scar formation. J Wound Care, 14 ［Rating］C1 （7）：301-305, 2005.（Level: V） ［Analysis］Two cohort studies1, 2）of direct suturing 6 ）WhitneyJ, Phillips L, Aslam R：Guidelines for the and skin grafts support performing wound closure treatment of pressure ulcers. Wound Repair Regen, under infection-free conditions. Although these stu- 14（6）：663-679, 2006. dies deal with general wounds and not pressure ulcers in particular, the findings are worth listing for their CQ 3.6：Which reconstructive surgical procedure is value in assessing surgical indication. considered especiallyeffective for pressure ulcers? Surgical reconstructive surgeryis recommended ［ Recommendation ］There are numerous options for D3 or D4 pressure ulcers, which penetrate beyond for reconstructive surgeryfor pressure ulcers, but subcutaneous tissue3）. When the wound depth insufficient evidence on the outcome of anyof these extends beyond the subcutaneous tissue in areas procedures. For this reason, no single surgical normallyfavoring pressure ulcer formation, tissue procedure can be recommended as applicable to all characteristicallyhaving low blood supplysuch as the cases. bone cortex, ligaments, joints and tendons capsules, ［Rating］C1 are often exposed in the wound bed. When pressure ［Analysis］Surgical reconstruction is indicated for ulcers fail to close after conservative treatment, pressure ulcers in which complications have been surgical intervention to repair the wound should be brought under control, and wound infection and

―G−40― ―52― necrotic tissue have been removed bysystemic, ment of wounds following debridement of infectious or conservative, physiotherapeutic, or surgical treat- necrotic tissue. ment. If the decision is made to perform surgical ［Rating］C1 debridement and reconstructive surgerysimul- ［ Analysis ］Negative pressure wound therapy taneously, any tissues involved in the pressure ulcer （NPWT）is designed to control the wound healing such as skin, granulation tissue, necrotic tissue, process under negative pressure conditions by subdermal sinuses, abscesses, bursae, and bone must covering the whole wound surface with an airtight first be removed surgically1）. According to one study, dressing. there is no significant difference in the cure rate The various kinds of NPWT equipment featured in between simultaneous and two-stage surgery2）. review articles and guidelines are commercially Within the past several years, three retrospective available. When using anyof these products, the case controlled studies have been published compar- wound surface should first be sealed air-tight using ing the recurrence rate among patients who received the sponge speciallyprovided for this purpose. A underwent surgical procedures3−5）. However, due to pressure of -125mmHG is typically recommended1−3）. the small number of cases in each study, and the lack The WOCN4） and NPUAP/EPUAP guidelines5） of standardization or uniformityin perioperative assign NPWT an evidence level of（B）for its efficacy management and care, the cure and recurrence rates in rapidlyreducing wound depth, and improving the claimed bythese reports cannot be assessed with any healing rate and granulation tissue formation. Furth- accuracy. er, two meta-analytical studies1, 2） rated NPWT more highlythan conventional treatments for its efficacy References against chronic skin ulcers, such as diabetic, stasis, 1）Yamamoto Y, Koyama A, Tsutsumida S, et al：Recon- and pressure ulcers, and trauma. However, a rando- structive Surgerywith the Fasciocutaneous Flap for mized controlled trial6）failed to demonstrate a signifi- the Treatment of Pressure Sores．Jpn J Plast Surg, cant difference between the efficacyof the VAC ® 41（ 12 ）：1113-1119. 1998.（ Level: IV ）（ Japanese, system and treatments based on wet-to-dry dressings English abstract） or topical agents. 2）Foster RD, AnthonyJP, Mathes SJ, et al：Flap selec- NPWT is an option for treating pressure ulcers tion as a determinant of success in pressure sore when infection/necrosis is controlled. However, there coverage. Arch Surg, 132（8）：868-873, 1997.（Evi- are no grounds for prioritizing it over other treat- dence level: V） ments. 3）Nojima K：The surgical Treatment of Pressure Ulcers : References Analysis of 92 cases. Tokyo Jikei-kai Ika Daigaku Zasshi. 119（ 6 ）：441-453, 2004.（ Level: V ） 1）Ubbink DT, Westerbos SJ, Evans D, et al：Topical （Japanese, English abstract） negative pressure for treating chronic wounds. 4）Kuwahara M, Tada H, Mashiba K, et al：Mortality Cochrane Database of Systematic Reviews 2008, Issue and recurrence rate after pressure ulcer operation for 3. Art. No.: CD001898. DOI：10. 1002/14651858. elderlylong-term bedridden patients. Ann Plast Surg, CD001898.pub2.（Level: I）. 54（6）：629-632, 2005.（Level: V） 2）Wanner MB, Schwarzl F, Strub B, et al：Vacuum- 5 ）Wong TC, Ip FK：Comparison of gluteal fasciocu- assisted wound closure for cheaper and more taneous rotational flaps and myocutaneous flaps for comfortable healing of pressure sores: a prospective the treatment of sacral sores. Int Orthop, 30（1）： study. Scand J Plast Reconstr Surg Hand Surg, 37 64-67, 2006.（Level: V） （1）：28-33, 2003.（Level: II） 3）Ford CN, Reinhard ER, Yeh D, et al：Interim analysis CQ 3.7 What kind of physiotherapy is recommended of a prospective, randomized trial of vacuum-assisted for pressure ulcers with low amounts of granulation closure versus the healthpoint system in the manage- tissue? ment of pressure ulcers. Ann Plast Surg, 49（ 1 ）： ［ Recommendation ］Negative pressure wound 55-61, 2002.（Level: II） therapy（NPWT）may be considered for the treat- 4）Ratliff CR,Tomaselli N：WOCN update on evidence-

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based guideline for pressure ulcers. J Wound Ostomy ［Analysis］The following is evidence pertaining to Continence Nurs, 37（5）：459-460, 2010. co-morbidityrisk factors for pressure ulcer develop- 5 ）National Pressure Ulcer AdvisoryPanel and Euro- ment. pean Pressure Ulcer AdvisoryPanel：Surgeryfor A studyinvolving participants with no pressure Pressure Ulcers. Prevention and treatment of press- ulcers at the time of admission to a chronic care ure ulcers: clinical practice guideline, 96-99, National hospital reported a correlation between cerebro- Pressure Ulcer AdvisoryPanel, Washington DC, vascular accidents and the development of pressure 2009. ulcers1）. Further, according to a studyof the database 6）Gregor S, Maegele M, Saucherland S, et al：Negative of nursing homes2）, as well as the results of a study Pressure Wound TherapyA Vacuum of Evidence?. conducted under similar conditions3）, pelvic fractures, Arch Surg, 143（2）：189-196, 2008.（Level: I） diabetes mellitus, and peripheral vascular disease were found to be positivelycorrelated to the incidence CQ 4 General management of pressure ulcer formation. Similarly, the outpatient CQ 4.1：Which underlying medical conditions may records of 75,158 cases demonstrated a positive entail the risk of leading to pressure ulcers? correlation between pressure ulcer formation and ［Recommendation］Pelvic fractures, diabetes mel- malignant tumors, Alzheimer Ss disease, congestive litus, cerebro-vascular diseases, and spinal cord heart failure, rheumatoid arthritis, osteoporosis, deep injuries potentiallylead to pressure ulcer formation venous thrombosis, diabetes mellitus, urinarytract due to patient immobility. infections, cerebro-vascular diseases, Parkinson Ss ［Rating］C1 disease and chronic obstructive pulmonarydisease. In addition, the Wound Healing Societyin the United States has reported spinal cord injuries as a risk factor in the development of pressure ulcers. The disease states mentioned above maybe considered risk factors for the development of pressure ulcers. However, other reports contradict these findings. For the purposes of the present guidelines, the comorbidityfindings for pelvic frac- tures, diabetes mellitus, cerebro-vascular accidents, as well as the spinal injuries mentioned bythe American guidelines are cited for their potential relevance as risk factors.

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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Dietarysupplementation in patients with hip frac- References tures, which are known to increase highlythe risk for 1）Berlowitz DR, Wilking SV：Risk factors for pressure pressure ulcer development, demonstrated both a low sores. A comparison of cross-sectional and cohort- rate of occurrence of Stage II pressure ulcers and in derived data. J Am Geriatr Soc, 37（11）：1043-1050, cases in which pressure ulcers eventuallydeveloped, 1989.（Level IV） a longer interval before occurrence5）. 2）Berlowitz DR, Brandeis GH, Anderson JJ, et al：Deri- On the basis of the evidence level of these studies, ving a risk-adjustment model for pressure ulcer nutritional intervention is assigned the recommenda- development using the Minimum Data Set. J Am tion rating of B with the proviso that the underlying Geriatr Soc, 49（7）：996-997, 2001.（Level IV） condition of the patient, if any, be duly considered. 3）Brandeis GH, Ooi WL, Hossain M, et al：A longitudin- References al studyof risk factors associated with the formation of pressure ulcers in nursing homes. J Am Geriatr 1）Langer G, Schloemer G, Knerr A, et al：Nutritional Soc, 42（4）：388-393, 2004.（Level IV） interventions for preventing and treating pressure 4）Margolis DJ, Knauss J, Bilker W, et al：Medical condi- ulcers. Cochrane Database Syst Rev, 2003.（Level I） tions as risk factors for pressure ulcers in an 2）Stratton RJ, Ek AC, Engfer M, et al：Enteral nutri- outpatient setting. Age Ageing, 32（ 3 ）：259-264, tional support in prevention and treatment of 2003.（Level IV） pressure ulcers：A systematic review and meta- 5）Stechmiller JK, Cowan L, WhitneyJD, et al：Guide- analysis. Ageing Res Rev, 4（ 3 ）：422-450, 2005. lines for the prevention of pressure ulcers. Wound （Level I） Repair Regen, 16（2）：151-168, 2008. 3）Bourdel-Marchasson I, Barateau M, Rondeau V, et al： A multi-center trial of the effects of oral nutritional CQ 4. 2：What form of nutritional intervention is supplementation in criticallyill older inpatients. recommended for the prevention of pressure ulcers in GAGE Group. Groupe Aquitain Geriatrique dSEvalua- malnourished patients? tion. Nutrition, 16（1）：1-5, 2000.（Level II） ［ Recommendation ］For patients suffering from 4）Hartgrink HH, Wille J, König P, et al：Pressure sores protein-energymalnutrition（ PEM ） , using a en- and tube feeding in patients with a fracture of the hanced energyand protein supplement after due hip：A randomized clinical trial. Clin Nutr, 17（6）： consideration of anyunderlyingconditions is recom- 287-292, 1998（Level II） mended. 5）Houwing RH, Rozendaal M, Wouters-Wesseling W, et ［Rating］B al：A randomised, double-blind assessment of the ［ Analysis ］A high-calorie, high-protein dietary effect of nutritional supplementation on the preven- supplement was found to be effective in promoting tion of pressure ulcers in hip-fracture patients. Clin healing of pressure ulcers among PEM（ protein- Nutr, 22（4）：401-405, 2003.（Level II） energymalnutrition ）patients who are unable to obtain the requisite quantities of these nutrients from CQ 4. 3：How should patients incapable of oral their regular meals1, 2）. intake of nutrition and hydration be fed? According to the Cochrane Database Systematic ［ Recommendation ］Consider supplying the re- Review1）, four studies examined the effects of dietary quired nutrition byenteral tube-feeding. When this is supplementation on pressure ulcers. In these studies not possible, consider parenteral feeding. the addition of 200 kcal to the total dailycaloric intake ［Rating］C1 over 15 days markedly decreased the rate of ［Analysis］Although a randomized controlled trial occurrence of pressure ulcers in comparison with the demonstrated that tube feeding clearlyincreased food control group（ 295 cases, or 40. 6%; 377 cases, or intake and resulted in significantlyhigher albumin 47.2% ）3）. A studyof the effect of supplemental and total protein levels after 1.2 weeks in comparison feeding in patients with femoral fractures similarly with the control group（ p ＜ 0. 001 ）, no significant demonstrated an improvement in clinical course, in effect was seen in terms of pressure ulcer prevention. addition to diminished incidence of complications4）. There are in fact no useful studies on the relationship

―G−43― ―55―

between the method of feeding and pressure ulcer used with elderlypatients. prevention, and existing recommendations are based ［Rating］C1 on expert opinion or represent the perspective of ［ Analysis ］Normally in a clinical setting, bioche- particular guidelines. The NPUAP/EPUAP quick mical measures such as serum albumin levels, as well reference guide states that patients should be fed by as physiological parameters, food intake rate, and enteral tube or intravenouslyif oral food intake is nutritional assessment and screening tools are used to insufficient2）. assess risk. Similarly, the Japanese guidelines for intravenous In analytical epidemiological studies of pressure and enteral feeding state that enteral feeding should ulcer risk, total protein, serum albumin, and pre- be used as much as possible in cases where oral food albumin values are examined to determine risk. intake is insufficient, and that intravenous feeding Among these, the serum albumin or prealbumin level should be performed if enteral feeding is not possible is a commonlyused index of pressure ulcer risk. Low or insufficient3）. The manner in which the patient is serum albumin values indicate high risk for pressure fed should be decided after due consideration of the ulcers1−7）. Values below 3.5 g/dl indicate a particularly prognosis, goals of treatment, and individual differ- high risk.1−6） However, because the serum albumin ences. level varies depending on inflammation, dehydration and other factors, this index merits a Recommenda- References tion Rating of no higher than C1. 1）Hartgrink HH, Wille J, König P, et al：Pressure sores Bodyweight measurements can be performed and tube feeding in patients with a fracture of the easilywithout the aid of special apparatuses, and is hip：A randomized clinical trial. Clin Nutr, 17（6）： the most convenient tool for assessing the nutritional 287-292, 1998.（Level II） state of the patient. Decrease in bodyweight is 2）European Pressure Ulcer AdvisoryPanel and Nation- thought to be a risk factor for pressure ulcers. Among al Pressure Ulcer AdvisoryPanel：Prevention and newlypatients at the Stage III or IV pressure ulcers, a treatment of pressure ulcers：quick reference guide. decrease in % usual bodyweight（UBW）is reported- National Pressure Ulcer AdvisoryPanel, Washington lycorrelated to increased pressure ulcer risk 8）. DC, 2009. Haydock and Hill report that moderately to severely 3 ）Japanese Societyfor Parenteral and Enteral Nutri- under-nourished surgical patients showed a decrease tion：Practical guidelines for parenteral and enteral in bodyweight of 9.6% and 19.6%, respectively,and nutrition 2 nd Ed, 7-8, Nankodo, Tokyo, 2007. wound healing was impaired more than in patients （Japanese） assessed to be in\goodScondition（p ＜ 0.001）9）.In a cohort studyexamining the risk for pressure ulcers CQ 4. 4：What indices can be used to assess the at Stage II or higher among in-patients who were level of malnutrition as a risk factor for pressure either bed-ridden or confined to a sitting position, a ulcers? decrease in bodyweight was reported to be a ［Recommendation］ significant risk factor for pressure ulcer 1. In the absence of inflammation or dehydration, development10）. According to the EAUAP nutritional serum albumin levels maybe used. guidelines, undesirable weight loss, defined as weight ［Rating］C1 loss exceeding 10% of normal bodyweight over 6 2. Rate of weight loss maybe considered for use. months, or exceeding 5% over 1 months, maypoint to ［Rating］C1 malnutrition, and requires regular monitoring of the 3. Consider using the rate of food intake or the patientSs bodyweight 11）. On the basis of the qualityof amount of food consumption as an index. the publications from which this information is taken, ［Rating］C1 the recommendations given here merit the rating of 4. Consider using Subjective Global Assessment C1. （SGA）. Although there is not sufficient evidence estab- ［Rating］C1 lishing a relationship between eating rate and 5. Mini Nutritional Assessment（ MNA ）maybe pressure ulcers, among the cases of pressure ulcer

―G−44― ―56― documented in Japan, a rate of food intake below 75% 1023-1028, 2002.（Level Ⅵ）（Japanese） of food offered has been documented in 48% of 5）Konagaya M, Takasaki K：The development of nutri- pressure ulcer patients12）. Further, the amount of food tional index for pressure ulcer incidence. Jpn J PU, 2 intake is one of the categories included on the Braden （3）：257-263, 2000.（Level Ⅳ）（Japanese, English Scale for pressure ulcer risk assessment, with a rate of abstract） food intake below 50% thought to entail a significantly 6）Sugiyama M, Nishimura A, Ohura T, et al：Effect of higher risk for pressure ulcer development13）. Use of nutritional care for prevention and treatment for the food intake rate as an index of malnutrition is pressure ulcers: Health and labor sciences Research assigned a recommendation rating of C1. Grants（H10-Comprehensive Research on Aging and The Subjective Global Assessment, published by Health-012）. 37-45, 2000.（Level Ⅳ）（Japanese） Detskyet al. in 1987, is widelyused as a comparatively 7）Rochon PA, Beaudet MP, McGlinchey-Berroth R, et precise tool for assessing the nutritional state of al：Risk assessment for pressure ulcers：an adapta- patients. However, it has been assigned the Recom- tion of the National Pressure Ulcer AdvisoryPanel mendation Rating of C1 due to the fact that at present risk factors to spinal cord injured patients. J Am onlyexpert opinion supports the relationship between Paraplegia Soc, 16（3）：169-177, 1993.（Level Ⅱ） SGA and pressure ulcer prevention. 8 ）Guenter P, Malyszek R, Bliss DZ, et al：Survey of In a cross-sectional studyof three assessment tools nutritional status in newlyhospitalized patients with for evaluating the nutritional state of patients, namely stage Ⅲ or stage Ⅳ pressure ulcers. Adv Skin Wound the mini nutritional assessment: MNA, bioelectrical Care, 13（4 Pt 1）：164-168, 2000.（Level VI） impedance analysis: BIA, and Barthel index: BI, the 9 ）Haydock DA, Hill GL：Impaired wound healing in MNA was found to have the strongest correlation to surgical patients with varying degrees of malnutri- the risk of pressure ulcer development. Further, a tion. JPEN J Parenter Enteral Nutr, 10（6）：550-554, cross sectional studyof MNA and other, similar 1986.（Level IV） assessment tools reported that screening patients S 10）Allman RM, Goode PS, Patrick MM, et al：Pressure nutritional status maybe a more effective indicator of ulcer risk factors among hospitalized patients with pressure ulcer risk than serum albumin and prealbu- activitylimitation. JAMA, 273（11）：865-870, 1995. min values14）. Because at present there are no useful （Level IV） studies examining the relationship between nutrition- 11）European Pressure Ulcer AdvisoryPanel：Nutrition- al assessment tools and pressure ulcer risk, the al guidelines for pressure ulcer prevention and recommendation rating of C1 has been assigned to the treatment. Registered charityNo：1066856, Euro- data given here. pean Pressure Ulcer AdvisoryPanel, 2003. 12 ）Ohura T, Nakajo T, Okada S, et al：Influence of References nutritional intervention to the patients who have risk 1）Reed RL, Hepburn K, Adelson R, et al：Low serum factors for pressure ulcer. Jpn JPU, 10（2）：122-129, albumin levels, confusion, and fecal incontinenceare 2008.（Level Ⅳ）（Japanese, English abstract） these risk factors for pressure ulcers in mobility-im- 13）Hengstermann S, Fischer A, Steinhagen-Thiessen E, paired hospitalized adults?. Gerontology, 49（ 4 ）： et al：Nutrition status and pressure ulcer：what we 255-259, 2003.（Level Ⅳ） need for nutrition screening. J Parenter Enteral Nutr, 2）Pinchcofsky-Devin GD, Kaminski MV Jr：Correlation 31（4）：288-294, 2007.（Level IV） of pressure sores and nutritional status. J Am Geriatr 14）Langkamp-Henken B, Hudgens J, Stechmiller JK, et Soc, 34（6）：435-440, 1986.（Level Ⅳ） al：Mini nutritional assessment and screening scores 3）Yoshio M, Shigeto M, Kohya O, et al：Risk factors for are associated with nutritional indicators in elderly pressure ulcers in bedridden elderlysubjects：Im- people with pressure ulcers. J Am Diet Assoc, 105 portance of turning over in bed and serum albumin （10）：1590-1596, 2005.（Level V） level. Geriatr Gerontol Int, 1：38-44, 2001.（Level Ⅳ） 4）Nakajo T, Oishi S：Prevention of pressure ulcer and CQ 4. 5：When is the systemic administration of nutrition management: Cutoff values of serum antibiotics（ antimicrobials ）indicated in patients albumin and hemoglobin. Geriatr Med, 40（ 8 ）： with an infected pressure ulcer?

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［ Recommendation ］If physical examination find- CQ 4. 6：Which antibiotics（ antimicrobials ）are ings or test results indicate advancing cellulitis and recommended for treating infection? osteomyelitis, necrotizing fasciitis, bacteremia, or ［ Recommendation ］Consider using empiric anti- sepsis, consider administering systemic antibiotics. If biotics to suspected pathogens common in clinical onlysymptomsof local infection are found, administra- settings. Reconsider using more specific antibiotics to tion of systemic antibiotics need not be considered. pathogens byreferring the results of susceptibility ［Rating］C1 testing. ［Analysis］An effort was made to identify specific ［Rating］C1 disease states in cases of infected pressure ulcers ［Analysis］There are no studies at present indicat- which required the systemic administration of antibio- ing the best choice of systemic antibiotic for infected tics. However, given the generallyaccepted notion pressure ulcers. In the NPUAP/EPUAP guidelines, that failure to administer systemic antibiotics entails \ Antibiotics should be chosen based on confirmed an intolerable risk to the patientSs health, there are no antibiotic susceptibilities of the suspected or known controlled studies examining the differences in the pathogens. For life-threatening infections, empiric effect of administering or not administering systemic antibiotics should be based on local antimicrobial antibiotics. Our recommendations here are therefore susceptibilitypatterns, and re-evaluated when defini- based on published guidelines or reviews. The tive cultures become available S1）. In the present NPUAP/EPUAP guidelines recommend using\sys- guidelines as well, the immediate administration of temic antibiotics for individuals with clinical evidence antibiotics appropriate to the suspected pathogen is of systemic infection, such as positive blood cultures, recommended. cellulitis, fasciitis, osteomylelitis, systemic inflamma- References toryresponse syndrome,or sepsis, if consistent with the individual Ss goals S1）. The WOCN guidelines 1 ）National Pressure Ulcer AdvisoryPanel and Euro- similarlyendorse the view that systemicantibiotics pean Pressure Ulcer AdvisoryPanel：Prevention should be administered, as needed, in cases of and treatment of pressure ulcers：clinical practice bacteremia, sepsis, advancing cellulitis and guideline, National Pressure Ulcer AdvisoryPanel, osteomyelitis2）. Washington DC, 2009. From a clinical point-of-view, if the physical examination findings or the test results are found to CQ 4.7：Which underlying conditions may pose a correspond to the condition of a given patient, risk of prolonging the healing of pressure ulcers? consider the administration of systemic antibiotics. ［ Recommendation ］Malignant tumors and car- However, for cases in which the infection is local, there diovascular diseases should be considered as factors is no evidence to support the use of systemic which mayprolong the healing of pressure ulcers. antibiotics. For such cases, refer to the sections ［Rating］C1 dealing with conservative treatment or surgical ［ Analysis ］Evidence relating to co-morbidity di- treatment. agnoses was assembled because of their potential importance as factors influencing the healing of References pressure ulcers, including chronic wounds. The 1 ）National Pressure Ulcer AdvisoryPanel and Euro- majorityof the information found was comprised of pean Pressure Ulcer AdvisoryPanel：Prevention expert opinions and case reports, with onlytwo and treatment of pressure ulcers：clinical practice analytical-epidemiological and case-controlled guideline, National Pressure Ulcer AdvisoryPanel, studies1, 2）. Washington DC, 2009. The rate of healing in pressure ulcers among 2）Wound OstomyContinence Nurses Society：Guide- cardiovascular patients was found to be significantly lines for prevention and management of pressure lower according to a cohort studyof pressure ulcer ulcers. 2nd edition, WOCN clinical practice guidelines patients1）. According to the findings of another cohort series 2, 2010. studyof cancer patients with pressure ulcers and other types of skin ulcer2）, cancer patients showed a

―G−46― ―58― significant lower rate of healing than non-cancer References patients. Further, according to expert opinion in Japan3）, the exacerbation of diabetes mellitus, malig- 1）Donini LM, De Felice MR, Tagliaccica A, et al：Nutri- nancies, liver cirrhosis, or peripheral vascular disease tional status and evolution of pressure sores in impeded the healing rate of pressure ulcers. geriatric patients. J Nutr Health Aging, 9（ 6 ）： In summary, malignancies and cardiovascular 446-454, 2005.（Level IV） diseases can be cited as comorbidityfactors which 2）European Pressure Ulcer AdvisoryPanel and Nation- mayprolong the healing of pressure ulcers. Although al Pressure Ulcer AdvisoryPanel：Prevention and specific epidemiological figures cannot be given for treatment of pressure ulcers：quick reference guide, lack of data, a general care regimen which includes National Pressure Ulcer AdvisoryPanel, Washington management of the patientSs condition and nutrition is DC, 2009. recommended in order to hasten healing of pressure ulcers in patients whose general health has been CQ 4.9：How much nutrition in general should be adverselyaffected bytheir disease state. provided to pressure ulcer patients? ［Recommendation］ References 1. In order to ensure adequate energyfor healing of 1 ）Jones KR, Fennie K：Factors influencing pressure pressure ulcers, recommend providing patients with ulcer healing in adults over 50: an exploratorystudy.J 1.5 times the basal energyexpenditure（BEE）. Am Med Dir Assoc, 8（ 6 ）：378-387, 2007.（ Level ［Rating］B IV） ［Recommendation］ 2）McNees P, Meneses KD : Pressure ulcers and other 2. Recommend providing additional protein as chronic wounds in patients with and patients without required. cancer: a retrospective, comparative analysis of ［Rating］B healing patterns. OstomyWound Manage, 53（2）： ［ Analysis ］Two systematic reviews have ex- 70-78, 2007.（Level IV） amined the effect of nutrition on pressure ulcers1, 2）. 3）Mino Y：The latest basic information: How to treat a The NPUAP/EPUAP guidelines recommend 30〜35 refractorypressure ulcer?. JPN J Clin Nurs（Rinsho kcal/kg of bodyweight as the basic energy Kango ）, 27（9）：1377-1382, 2001.（ Level VI ） requirement3）. A randomized controlled study4） of （Japanese） nutritional intervention in patients with pressure ulcers found that the intervention group, who were CQ 4.8：Should a nutritional screening and assess- given 300 kcal in addition to their dailydiet（ 1. 55 ment be performed for pressure ulcer patients? times the BEE ）, showed a significantlygreater ［ Recommendation ］A nutritional screening and reduction in wound surface area and a faster wound assessment and nutritional intervention maybe healing rate 8 weeks after the intervention than the considered if required. control group, who were given only1. 16 times the ［Rating］C1 BEE. Because this studyeliminated factors unrelated ［Analysis］Assessing the nutritional status of the to nutrition and used the same nutritional source for pressure ulcer patient and instituting the nutritional all of its subjects, it merits the Recommendation regimen most appropriate for each case has been rating of B. found to contribute to improving the patient Ss With regard to the quantityof protein in the diet, health1）. The NPUAP/EPUAP quick reference greater reduction in the wound surface area was seen guide2） also recommends that screening and assess- in patients who had received large quantities of ment of the patientSs nutritional status be conducted protein（energyratio 25%）via enteral tube feeding when the patient is admitted to hospital, shows compared to those who had received onlythe changes in health condition, or shows evidence of standard diet5）. Further, a group of under-nourished retardation of wound healing. patients who had received large quantities of protein in their diet either via enteral tube feeding or as a dietarysupplement（24% protein; 61g/L）reportedly

―G−47― ―59― showed a greater reduction in wound surface area Am Geriatr Soc, 41（4）：357-362, 1993.（Level II） after 8 weeks compared to the group who had 7）Cereda E, Gini A, Pedrolli C, et al：Disease-specific, received only14% protein（ 37g/L ） 6）. However, versus standard, nutritional support for the treatment because the number of subjects was small and the of pressure ulcers in institutionalized older adults：a experimental design was inadequate, these data have randomized controlled trial. J Am Geriatr Soc, 57 been assigned a low Evidence Level. On the other （8）：1395-1402, 2009.（Level II） hand, a randomized controlled studyexamining the effect of providing patients with a diet augmented CQ 4.10：Should the diet of pressure ulcer patients with larger quantities of specific nutrients as required, be supplemented with anyspecific nutrients? demonstrated an improved PUSH scores and wound ［ Recommendation ］Patients Sdiet maybe sup- healing rate in the intervention group, although a plemented with zinc, arginine, and ascorbic acid to comparison of energycontent and amount of added prevent deficiencies of these nutrients. protein with wound healing rate and PUSH scores ［Rating］C1 showed no difference7）. However, the studyemployed ［Analysis］Of the systematic reviews examining a relativelysmall number of cases and failed to explain nutritional supplementation for the prevention and the relationship between individual nutrients, press- healing of pressure ulcers, one deals specificallywith ure ulcer healing rate, and PUSH scores. The the supplementation of zinc, while two are concerned NPUAP/EPUAP guidelines3）recommend 1.25〜1.5g/ specificallywith ascorbic acid 1）. kg/dayaccording to the severityof the symptoms 3）, With regard to zinc, one studyreported no but because there are no recent studies on the basis of significant difference in pressure ulcer healing rate which specific recommendations can be made, we between ten individuals who had been administered have not indicated anyspecific amount for protein 200mg/dayof zinc sulphate and eight individuals who supplementation. had been administered a placebo over 1〜2 months2）. However, the studywas inadequate because of the References small number of cases, and the lack of clarity 1）Langer G, Schloemer G, Knerr A, et al：Nutritional regarding the treatment procedures, food intake, interventions for preventing and treating pressure nutritional status, and serum zinc level. The NPUAP/ ulcers. Cochrane Database Syst Rev, 4：CD003216, EPUAP guidelines3） recommend that 40mg/dayor 2003.（Level I） more of zinc be given as a nutritional supplement to 2）Stratton RJ, Ek AC, Engfer M, et al：Enteral nutri- patients with zinc deficiency. However, because there tional support in prevention and treatment of are no high-evidence level studies examining the pressure ulcers：a systematic review and metaanaly- efficacyof zinc supplementation for pressure ulcer sis. Ageing Res Rev, 4（3）：422-450, 2005.（Level I） healing, the information discussed here has been 3 ）National Pressure Ulcer AdvisoryPanel and Euro- assigned a Recommendation Rating of C1. pean Pressure Ulcer AdvisoryPanel：Prevention Randomized controlled trials4, 5）examining the ther- and treatment of pressure ulcers：clinical practice apeutic effect of ascorbic acid on pressure ulcer guideline. National Pressure Ulcer AdvisoryPanel, healing found that 500 mg of ascorbic acid adminis- Washington DC, 2009. tered twice dailyover one month resulted in a 85% 4 ）Ohura T, Nakajo T, Okada S, et al：Evaluation of reduction in wound surface area compared with 43% effects of nutrition intervention on healing of pressure for the placebo group. However, because each group ulcers and nutritional states：randomized controlled in the studywas comprised of onlyten subjects, and trial. Wound Rep Reg, 19：330-336, 2011.（Level II） because there are no other studies providing useful 5）Chernoff RS, Milton KY, Lipschitz DA：The effect of information, we have confined our recommendation a veryhigh-protein liquid formula on decubitus ulcers onlyto supplementing the patientSs diet with enough healing in long term tube-fed institutionalized pa- ascorbic acid to prevent a deficiency. tients. J Am Diet Assoc, 90：A-130, 1990.（Level II） Onlyone historical controlled studydealing with 6）Breslow RA, Hallfrisch J, GuyDG, et al：The impor- arginine supplementation exists to date6）. In this tance of dietaryprotein in healing pressure ulcers. J study, 18 functional spinal injury patients who were

―G−48― ―60― also suffering from pressure ulcers were given 9g/day ［Rating］C1 of arginine until the pressure ulcers completely ［Analysis］A studyof the economic viabilityof a healed. The rate of healing was then compared with nutrition support team（ NST ）in pressure ulcer that of the control group consisting of patients who management found that two years after deployment, had been treated in the past for spinal injuries. The the incidence of pressure ulcers fell from 14. 9% to result indicated that the period required for total 5.85%（roughly1/3 of the original rate）in the study healing of the pressure ulcers in the experimental population and that the cost of treating pressure group was significantlyshorter than that for the ulcers substantiallyfell in the second yearof the NSTS control. However, because the control group used in s operations. Two other studies have reported similar the studyconsisted of patients who had been involved findings with regard to the economic viabilityof the in a separate, past study, and because there was NST 2, 3）. Another studyreported an improvement in inadequate information regarding nutritional status the patientsScondition as a result of intervention by and lack of uniformityin the conditions, we were the NST, but because the number of cases was small, unable to assign a Recommendation Rating higher no statistical data were given. than C1. The EPUAP nutritional guidelines recommend that for grade III and IV pressure ulcers, a multi- References disciplinaryteam assess the basic metabolic rate of 1）Stratton RJ, Ek AC, Engfer M, et al：Enteral nutri- the patient and monitor the amount of exudates from tional support in prevention and treatment of the wound 5）. pressure ulcers：a systematic review and metaanaly- All of the studies examined are unanimous in sis. Ageing Res Rev, 4（3）：422-450, 2005.（Level II） asserting the need for preventive intervention and 2）Norris JR, Reynolds RE：The effect of oral zinc sul- recommend appropriate nutritional assessment, as fate therapyon decubitus ulcer. J Am Geriatr Soc, well as intervention bythe registered dietician or the 19：793-797, 1971.（Level II） NST. However, none of the studies mentioned gives 3 ）National Pressure Ulcer AdvisoryPanel and Euro- specific data concerning the efficacyof this form of pean Pressure Ulcer AdvisoryPanel：Prevention intervention in promoting pressure ulcer healing. and treatment of pressure ulcers：clinical practice References guideline. National Pressure Ulcer AdvisoryPanel, Washington DC, 2009. 1）Okude K, Higashiguchi T, Fukumura S, et al：Eco- 4）Taylor TV, Rimmer S, Day B, et al：Ascorbic acid nomic effect of pressure ulcers management based on supplementation in the treatment of pressure-sores. nutrition therapy. J Jpn Soc Parenteral Enteral Lancet, 2（7880）：544-546, 1974.（Level II） Nutrition, 17（ 4 ）：29-33, 2002.（ Level V ） 5）Ter Riet G, Kessels AG, Knipschild PG：Randmized （Jananese, English abstract） clinical trial of ascorbic acid in the treatment of press- 2）Onoki K, Isozaki T, Yonekawa O, et al：Medical eco- ure ulcers. J Clin Epidemiol, 48（ 12 ）：1453-1460, nomic effect of nutrition support team（NST）in a 1995.（Level II） general hospital in Japan. Med J Seirei Hamamatsu 6）S Brewer, K Desneves, L Pearce, et al：Effect of an General Hospital, 4（ 1 ）：23-27, 2004.（ Level V ） arginine-containing nutritional supplement on press- （Japanese） ure ulcer in communityspinal patients. J Wound Care, 3）Toma T, Kitanishi M, Hasegawa K：Clinical outcom- 19（7）：311-316, 2010.（Level III） es of femoral neck fracture with nutrition support team. Central Japan J of Orthopaedic Surgery& CQ 4.11：Should a registered dietician or multidisci- Traumatology, 48（ 4 ）：659-660, 2005.（ Level V ） plinarynutritional team participate in the care of （Japanese） pressure ulcer patients? 4）Ohara H, Kurihara Y, Dohi M：Improvement effect of ［ Recommendation ］Participation bya registered nutritional management on the long term hospitalized dietician or multidisciplinarynutrition support team patients. Jpn J National Med Service, 59（6）：300- in the care of pressure ulcer patients maybe 305, 2005.（Level V）（Japanese） recommended. 5）European Pressure Ulcer AdvisoryPanel：Nutrition-

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Fig. 6 Algorithm illustrating preventive care options

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

al guidelines for pressure ulcer prevention and group showed a significantlygreater increase in body treatment. Registered charityNo：1066856, Euro- weight 12 weeks after commencement of the study pean Pressure Ulcer AdvisoryPanel, 2003. compared with the control group（p ＜ 0.001）, which showed no change in bodyweight at all 1）. Further, the CQ 4.12：Should bodyweight be used as a means of wound size in the intervention group decreased more assessing the efficacyof nutritional supplementation rapidlythan in the control group（p ＜ 0.001）. The in pressure ulcer patients? results of this studyhave been deemed reliable ［Recommendation］Recommend using bodyweight because factors unrelated to nutrition but affecting as a means of assessing the effectiveness of nutritional the pressure ulcers were controlled. Accordingly, supplementation if edema or dehydration can be ruled bodyweight is recommended as an index for out. assessing whether the patient has received adequate ［Rating］B nutrition. ［Analysis］A randomized controlled study examin- Further, the NPUAP/EPUAP guidelines2） recom- ing the effectiveness of nutritional intervention in mend that, if the bodyweight of a pressure ulcer pressure ulcer patients found that the intervention patient decreases, the patient should be given

―G−50― ―62― sufficient calories to restore bodyweight. However, stract） edema and dehydration should first be ruled out as 3）Imai K, Kadowaki T, Aizawa Y：Standardized indi- potential causes of fluctuations in bodyweight. ces of mortalityamong persons with spinal cord injury：Accelerated aging process. Ind Health, 42 References （2）：213-218, 2004.（Level IV） 1 ）Ohura T, Nakajo T, Okada S , et al：Evaluation of effects of nutrition intervention on healing of pressure CQ 5.2：Which methods are effective for prevent- ulcers and nutritional states：randomized controlled ing pressure ulcer development in spinal cord injury trial. Wound Repair Regen, 19：330-336, 2011. patients? （Level II） ［ Recommendation ］Conducting rehabilitation 2 ）National Pressure Ulcer AdvisoryPanel and Euro- while monitoring interface pressure maybe consi- pean Pressure Ulcer AdvisoryPanel：Prevention dered. and treatment of pressure ulcers：clinical practice ［Rating］C1 guideline. National Pressure Ulcer AdvisoryPanel, ［ Analysis ］Hirose et al1）. have compared the Washington DC, 2009. length of time that elapsed between discharge from hospital following treatment for pressure ulcers and CQ 5 Rehabilitation readmission for recurrence among patients who CQ 5.1：Which factors account for pressure ulcer received rehabilitation either with or without monitor- development in chronic spinal cord injurypatients? ing interface pressure. The results of the study ［Recommendation］For patients with a historyof demonstrated a significantlylower incidence of pressure ulcers, vigilance is recommended to prevent recurrence among patients when their interface recurrence. pressure was monitored during rehabilitation（p ＜ ［Rating］B 0.02）. Further, three separate studies2−4）on pressure ［ Analysis ］A systematic review1） which has ex- ulcer prevention for spinal cord injurypatients amined the factors leading to pressure ulcer develop- performed at multiple rehabilitation facilities in Japan ment among chronic spinal cord injurypatients found reported that seat-type pressure measuring devices gender（greater susceptibilityof men）, length of time are extremelyuseful in gauging pressure on the following appearance of the wound, complete injury buttocks and in providing feedback to the patient rather than partial injury, the presence of deep vein during rehabilitation. On this basis, we have assigned thrombosis, presence of pneumonia, historyof press- the recommendation rating of C1 to this section. ure ulcers, to be relevant factors. No relationship was References found between age and degree of injury. Among studies conducted in Japan, some have reported that 1）Hirose H, Niituma J, Iwasaki Y, et al：An approach to all pressure ulcers recur within 14 years2）, or that the determine situations in which pressure ulcers occur recurrence maylead to sepsis or death 3）. The in patients with spinal cord injury. Jpn J PU, 12（2）： Recommendation Rating of B is assigned to these 118-125, 2010.（ Level IV ）（ Japanese, English ab- evidence sources in view of the apparentlyserious stract） consequences of recurrence. 2）Morita T, Maeda J, Sakuma F, et al：A case studyof a spinal cord injury（ SCI ）patient who developed a References pressure ulcer after changing his wheelchair cushion 1）Gelis A, Dupeyron A, Legros P, et al：Pressure ulcer and life-style-Physical therapy intervention of the risk factors in persons with spinal cord injuryPart2： treatment of pressure ulcer in SCI-. Physical Therapy The chronic stage. Spinal Cord, 47：651-661, 2009. Japan, 35（3）：104-109,2008.（Level V）（Japanese） （Level I） 3）Matsubara H, Hirose H, Hama Y：Fabrication of seat- 2）Hirose H, Niituma J, Iwasaki Y, et al: An approach to ing cushion for a person with spinal cord injuryand determine situations in which pressure ulcers occur hip disarticulation. J Jpn Acad Prosthetists Orthotists, in patients with spinal cord injury. Jpn J PU, 12（2）： 12（1）：48-53, 2004.（Level V）（Japanese） 118-125, 2010.（ Level IV ）（ Japanese, English ab- 4 ）Kaneko M, Nakashima M, Kurosaki S, et al：Indi-

―G−51― ―63―

viduallyplanned visits for self-care guidance and ［Rating］B livelihood support byco-medical staff could prevent ［Analysis］A randomized controlled trial involving pressure ulcer recurrence in a patient with spinal 57 patients in two orthopaedic wards examined the injury. Jpn J PU, 132-136, 2010.（ Level V ） effect of limiting the time patients could sit in chairs （Japanese, English abstract） placed near their beds1）. The studyindicated that limiting sitting time to two hours or less resulted in a CQ 5.3：What type of cushion should be used with significantlylower rate of pressure ulcer formation elderlypatients in a seated position to prevent compared to unlimited sitting time（p ＜ 0.001）. The pressure ulcers? NPUAP/EPUAP guidelines, which cite the same ［Recommendation］A pressure-redistributing seat study, assign the data a recommendation rating of B cushion for individuals with spinal cord injuryis and endorse the view that seating time should be recommended to prevent pressure ulcer development limited, although theydo offer specific recommenda- while seated. tions on the length of sitting time2）. ［Rating］B On the basis of these considerations, we have also ［Analysis］A randomized controlled trial compar- decided to recommend onlythat seating time be ing the efficacyof three typesof pressure- limited without offering anyspecific recommenda- redistributing seat cushions designed for spinal cord tions regarding permissible seating time. injurypatients with that of a segmented foam cushion References （ 8cm in thickness ）in preventing pressure ulcers1） found that while the rate of pressure ulcer develop- 1）Gebhardt K, Bliss MR：Preventing pressure sores in ment decreased significantlyin the tissue overlying orthopedic patients is prolonged chair nursing the ischial bone as a result of the use of pressure- detrimental. J Tissue Viability, 4（ 2 ）：51-54, 1994. redistributing seat cushions（p = 0.04）, there was no （Level II） measurable change in the rate of pressure ulcer 2 ）National Pressure Ulcer AdvisoryPanel and Euro- development in the coccyx and sacral areas. However, pean Pressure Ulcer AdvisoryPanel：Prevention there is a case report published in Japan claiming that and treatment of pressure ulcers：clinical practice the application of a segmented air cushion 10 cm in guideline. National Pressure Ulcer AdvisoryPanel, thickness to the ischial area of three elderlypatients Washington DC, 2009. did not result in the development of pressure ulcers2）. On the basis of these data, the methods discussed here CQ 5.5：At what intervals should the seated indi- are assigned a recommendation rating of B. vidual be repositioned? ［Recommendation］Repositioning every15 min is References recommended for seated individuals who are capable 1）Brienza D, KelseyS, Karg P, et al：A randomized of changing their bodyposition without assistance. clinical trial on preventing pressure ulcers with ［Rating］C1 wheelchair seat cushions. J Am Geriatr Soc, 58： ［Analysis］There are no published studies to date 2308-2314, 2010.（Level II） addressing the question of optimal intervals for body 2）Hirose H, Tanaka H, Mawaki A, et al: Case studies of repositioning for wheelchair-bound individuals who coccygeal pressure ulcers caused by improper are capable of changing their bodyposition without wheelchair seating. Jpn J PU, 13（ 1 ）：54-60, 2011. assistance. However, the WOCN guidelines1）, as well （Level V）（Japanese, English abstract） as the Centers for Medicare and Medicaid2）, recom- mend an interval of 15 minutes. CQ 5.4：Should limitations be set on the length of On the basis of this information, we recommend time in which the individual remains continuously that wheelchair-bound individuals capable of reposi- seated? tioning on their own do so at regular 15 minute ［ Recommendation ］Limitations on sitting time intervals, although it should be noted that there is no should be set if the elderlyindividual is unable to clear evidence endorsing this recommendation. reposition without assistance.

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Washington DC, 2009. References 3）AHCPR：AHCPR Supported clinical practice guide- 1）Ratliff CR, Bryant DE：Wound, Ostomy, and Conti- lines. 3. Pressure ulcers in adults：Prediction and nence Nurses Society（WOCN）：Guideline for pre- prevention, Clinical practice guideline Number 3, vention and management of pressure ulcers. WOCN AHCPR Pub. No.92-0047. clinical practice guideline No.2. WOCN, Glenview, IL, 2003. CQ 5.7：Should donut-type devices be used? 2）CMS Manual System：Pub. 100-07 State Operations, ［ Recommendation ］Donut-type devices are not Provider Certification, Transmittal 4. Guidance to recommended. Surveyors for Long Term Care Facilities, 2004. ［Rating］D ［Analysis］A case report investigating the effect of CQ 5. 6：Should the individual Ss posture while various types of cushion on the development of seated be considered? pressure ulcers in hospitalized elderlypatients ［Recommendation］The alignment and balance of indicated that donut-shaped devices either conduced the seated individualSs bodyshould be considered. to the development of pressure ulcers or worsened ［Rating］C1 existing cases1）. The NPUAP/EPUAP guidelines ［Analysis］To date there exist only one case report similarlyrecommend,\Avoid use of syntheticsheeps- and two guidelines addressing the question of the kin pads; cutout, ring, or donut type devices; and effect that prolonged sitting has on pressure ulcers. water-filled gloves S2）. The WOCN guidelines also According to the case report1）, three patients at a state,\Avoid foam rings, foam cutouts, or donut type nursing home for elderlywith shallow ulcers in the devicesS3）. coccygeal area underwent rehabilitation with the The preponderance of evidence suggests that assistance of a trained physical therapist who chose donut-shaped devices should be avoided; recom- bodypositions and support surfaces according to mendation rating D. exercise physiological principles to lessen pressure on References the wounds. As a result of this treatment, the pressure ulcers healed successfullyeven while the patients 1）Crewe RA：Problems of rubber ring nursing cushions remained in their wheelchair. The NPUAP/EPUAP and a clinical surveyof alternative cushions for ill guidelines recommend\ selecting a posture that is patients. Care Sci Pract, 5（2）：9-11, 1987.（Level acceptable for the individual and minimizes the V） pressures and shear exerted on the skin and soft 2 ）National Pressure Ulcer AdvisoryPanel and Euro- tissuesS2）. The WOCN guidelines also statehspecial pean Pressure Ulcer AdvisoryPanel：Prevention attention to the individual's anatomy, postural align- and treatment of pressure ulcers：clinical practice ment, distribution of weighti3）. guideline. National Pressure Ulcer AdvisoryPanel, On the basis of the above information, measures to Washington DC, 2009. prevent pressure ulcer development can be im- 3）AHCPR：AHCPR Supported clinical practice guide- plemented even while the patient remains confined to lines. 3. Pressure ulcers in adults：prediction and a sitting position; recommendation rating C1. prevention, Clinical practice guideline Number 3, AHCPR Pub. No.92-0047. References

1）Hirose H, Tanaka H, Mawaki A, et al：Case studies of CQ 5.8：What kind of physical modality can be used coccygeal pressure ulcers caused by improper to treat muscular atrophy? wheelchair seating. Jpn J PU, 13（ 1 ）：54-60, 2011. ［ Recommendation ］Consider using electric sti- （Level V）（Japanese, English abstract） mulation therapy. 2 ）National Pressure Ulcer AdvisoryPanel and Euro- ［Rating］C1 pean Pressure Ulcer AdvisoryPanel：Prevention ［Analysis］Although there is a case report1）and a and treatment of pressure ulcers：Clinical practice case series2） examining the use of neuromuscular guideline. National Pressure Ulcer AdvisoryPanel, electric stimulation therapyto treat muscular atro-

―G−53― ―65― phy, these reports are concerned only with how to movement and decreasing the size of pressure ulcers, maintain muscular layer thickness and what changes but fails to offer precautionaryadvice on how to to make in the dailyactivityof individuals, but do not implement passive exercises, and recommends pas- address the issue of pressure ulcer prevention. The sive exercises involving the elbow and knee joints for review of the literature pertaining to this topic is of a treatment of pressure ulcers in the sacral region. general nature, discussing the effect on muscle cross- These reports fail to clarifywhether such exercises sectional area, but omitting discussion of pressure are sufficient completelyto prevent joint contracture. ulcers. Moreover, the two case reports cited earlier However, because passive exercises are effective in focus on electric stimulation therapyusing implanted maintaining or improving range of movement, which electrodes, while their remarks concerning surface in turn can prevent joint contracture, theyhave been electrodes are based solelyon expert opinion. For assigned the recommendation rating of C1. these reasons, while the use of electric stimulation References therapyto treat muscular atrophycan have positive effects on the prevention of pressure ulcers, their use 1）AM Moseley, RD Herbert, EJ Nightingale, et al：Pas- merits a recommendation rating of no higher than C1 sive stretching does not enhance outcomes in patients due to the lack of sufficient evidence. with plantar flexion contracture after cast immobiliza- tion for ankle fracture：a randomized controlled trial. References Arch Phys Med Rehabil, 86（ 6 ）：1118-1126, 2005. 1）Bogie KM, Wang X, Triolo RJ：Long-term prevention （Level II） of pressure ulcers in high-risk patients：A single case 2）TM Steffen, LA Mollinger：Low-load, prolonged st- studyof use of gluteal neuromuscular electric retch in the treatment of knee flexion contractures in stimulation. Arch Phys Med Rehabil, 87（ 4 ）：585- nursing home residents. Phys Ther, 75（10）：886- 591, 2006.（Level V） 897, 1995.（Level IV） 2 ）Sanjeev A, Triolo RJ, Kobetic R, et al：Long-term 3）HarveyLA, BattyJ, Crosbie J, et al：A randomized user perceptions of an implanted neuroprosthesis for trail assessing the effects of 4 weeks of daily exercise, standing, and transfers after spinal cord stretching on ankle mobilityin patients with spinal injury. J Rehab Res Develop, 40（3）：241-252, 2003. cord injuries. Arch Phys Med Rehabil, 81（ 10 ）： （Level V） 1340-1347, 2000.（Level II） 3）Giangregorio L, McCartneyN：Bone loss and muscle 4）Fox P, Richardson J, MCInners B, et al：Effectiveness atrophy in spinal cord injury：Epidemiology, fracture of a bed positioning program for treating older adults prediction, and rehabilitation strategies. J Spinal Cord with knee contractures who are institutionalized. Med, 29（5）：489-500, 2006.（Level VI） Phys Ther, 80（4）：363-372, 2000.（Level II） 5 ）Shimizu M, Shibata S：Effect of passive range of CQ 5.9：What kind of therapeutic exercise can be motion exercise for treatment of stage IV pressure used to treat joint contracture? ulcer in late-stage elderly. Nihon Kango Gakkai ［Recommendation］Consider using passive range Ronbunsyu Rounenkango, 38：155-157, 2007.（Level of motion exercises. V）（Japanese） ［Rating］C1 ［Analysis］Three randomized controlled studies1−3） CQ 5.10：Should tissue overlying bony prominen- and one case report4） discuss the use of therapeutic ces be massaged? exercise to treat joint contracture in individuals at ［Recommendation］Massaging areas covering bony risk of developing pressure ulcers. Neither report prominences is not recommended. found therapeutic exercise to be effective in prevent- ［Rating］D ing joint contracture and in addition make no mention ［Analysis］One systematic review and two rando- of pressure ulcers. In another case report, Shimizu mized controlled trials examine the use of massage in addresses the issue of joint contracture and therapeu- pressure ulcer care and management. In the systema- tic exercise and claims that the use of passive tic review1）, although claims are made regarding the exercises was effective in improving the range of efficacyof massage therapyin improving skin

―G−54― ―66― temperature and subcutaneous blood circulation, none healed successfullyeven while the patients remained of these claims are supported bystatisticallysignifi- in their wheelchair. The NPUAP/EPUAP guidelines2） cant findings. Further, the same work indicates that a recommend re-evaluating the patients Spressure large number of studies reviewed recommend avoid- ulcer state, and on the basis of the findings, selecting ing massaging bonyprominences. A randomized an appropriate cushion, limiting sitting time, and controlled trial2）involving 144 subjects scoring 20 or determining the effects of posture to avoid pressure lower on the Braden Scale and at high risk of pressure on the wound area to enable the patient to continue ulcers examined the use of skin cream when using the wheelchair. For these reasons, the methods massaging the individual. The studyfound that there described above are assigned the recommendation was no statistical difference in the rate of pressure rating of C1. ulcer development in relation to the use of skin cream References when massaging. The WOCN guidelines3） also state that strong massaging should be avoided. In sum- 1）Hirose H, Tanaka H, Mawaki A, et al：Case studies of mary, the evidence given above generally indicates coccygeal pressure ulcers caused by improper that massaging bonyprominences should be avoided; wheelchair seating. Jpn J PU, 13（ 1 ）：54-60, 2011. recommendation rating D. （Level V）（Japanese, English abstract） 2 ）National Pressure Ulcer AdvisoryPanel and Euro- References pean Pressure Ulcer AdvisoryPanel：Prevention 1）Duimel-Peeters IG, Halfens RJ, Berger MP, et al：The and treatment of pressure ulcers：Clinical practice effects of massage as a method to prevent pressure guideline. National Pressure Ulcer AdvisoryPanel, ulcers. A review of the literature. OstomyWound Washington DC, 2009. Manage, 51（4）：70-80, 2005.（Level I） 2）Duimel-Peeters IG, JG Halfens R, Ambergen AW, et CQ 5. 12：What kind of physical modality can be al：The effective of massage with and without used for patients with infected pressure ulcers? dimethyl sulfoxide in preventing pressure ulcers：A ［ Recommendation ］Hydrotherapymaybeconsi- randomized, double-blind cross-over trial in patients dered. prone to pressure ulcers. Int J Nurs Stud, 44：1285- ［Rating］C1 1295, 2007.（Level II） ［Analysis］The NPUAP/EPUAP guidelines state 3）Catherine R Ratliff：WOCNNs evidence based press- considering a course of whirlpool for reducing ure ulcer guideline. Adv Skin Wound Care, 18（4）： bioburden and infection1）. Although hydrotherapy 204-208, 2005. providing agitation and turbulence to the water by mixing air and water byturbines in a tank has not CQ 5.11：How can dailyuse of the wheelchair by been found to effective in suppressing infection, patients with shallow pressure ulcers be facilitated? according to expert opinion2）it is effective in reducing ［Recommendation］A suitable sitting posture, an the bacterial load in wounds, therebypromoting appropriate support cushion, and limitation on sitting wound healing. For this reason this form of therapy time maybe considered. has been assigned the recommendation rating of C1. ［Rating］C1 References ［Analysis］To date there exist only one case report and two guidelines addressing the question of what 1 ）National Pressure Ulcer AdvisoryPanel and Euro- effect a sitting posture has on pressure ulcers. pean Pressure Ulcer AdvisoryPanel：Prevention According to the case report1）, three patients at an and treatment of pressure ulcers：clinical practice elderlycare facilitywith shallow ulcers in the guideline. National Pressure Ulcer AdvisoryPanel, coccygeal area underwent rehabilitation with the Washington DC, 2009. assistance of a trained physical therapist who chose 2）Burke D, Ho C, Saucier M, et al：Effects of hydro- bodypositions and support surfaces according to therapyon pressure ulcer healing. Am J PhysMed kinesiologyto lessen pressure on the pressure ulcers. Rehabil, 77（5）：394-398, 1998.（Level IV） As a result of this procedure, the pressure ulcers

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CQ 5. 13：What kind of physical modality can be near infrared therapy. These studies have found near used for pressure ulcers containing necrotic tissue? infrared therapyto be effective in promoting wound ［Recommendation］Consider hydrotherapy or pul- reduction. Although near infrared irradiation was satile lavage with or without suction. found to increase blood flow in the wound periphery ［Rating］C1 with significantlypositive effects on wound healing 7）, ［Analysis］Based on expert opinion, the NPUAP/ the mechanism underlying this phenomenon has not EPUAP guidelines1） state to consider a course of yet been explained and for this reason this technique whirlpool as an adjunct for wound cleansing and has been assigned a recommendation rating of C1. facilitating healing. The same guidelines further state Ultrasound/ultraviolet-C irradiation has been found to to consider a course of pulsatile lavage with suction reduce wound size8）, but the wayin which each for wound cleansing and debridement. In Japan the intervention produces these results has not been Hubbard tank is used in wound cleansing procedures, clarified. In addition, the one randomized controlled but no studies assessing its efficacyhave been trial12）examining the efficacyof low-level laser irradia- published to date. Given these considerations, the tion on wound healing has not reported significant methods described here have been assigned the improvement8, 9）. recommendation rating of C1. Although the systematic review of ultrasound therapyhas reported less than adequate results for References this form of therapy, in a case report, Maeshige et al.11） 1 ）National Pressure Ulcer AdvisoryPanel and Euro- state that ultrasound therapyhad a positive effect on pean Pressure Ulcer AdvisoryPanel：Prevention reducing wound size. For this reason, ultrasound and treatment of pressure ulcers：clinical practice therapyhas been assigned the recommendation guideline. National Pressure Ulcer AdvisoryPanel, rating of C1. Washington DC, 2009. Non-thermal pulsed electromagnetic therapy12） showed a positive effect on the reduction of wound CQ 5. 14：What kind of physical modality can be size, but this modalityis assigned the recommenda- used to promote wound reduction? tion rating of C1 due to the small size of randomized ［Recommendation］ clinical trial. 1. Implementing electrical stimulation therapyis References recommended. ［Rating］B 1）Gardner S, Frantz R, Schmidt F：Effect of electrical 2. Near infrared therapy, ultrasonic therapy, or stimulation on chronic wound healing：A meta- electromagnetic therapymaybe considered. analysis. Wound Repair Regen, 7（6）：495-503, 1999. ［Rating］C1 （Level I） ［Analysis］One meta-analysis1）and one systematic 2）Regan MA, RWTeasell, DL Wolfe, et al：A systematic review2） have compared the relative efficacyof review of therapeutic interventions for pressure electrical stimulation therapyand conventional ther- ulcers after spinal cord injury. Arch Phys Med apies for treating pressure ulcers, including chronic Rehabil, 90：213-231, 2009.（Level I） ulcers. The recommended parameters for electrical 3）Stefanovska A, Vodovnik L, Benko H, et al：Treat- stimulation therapydiverge widelyin these studies, ment of chronic wound bymeans of electric and but the results reported for this form of treatment are electromagnetic fields. Part2. Value of FES para- uniformlypositive. Randomized controlled studies meters for pressure sore treatment. Med Biol Eng using both direct micro-current stimulation3） as well Comput, 31（3）：213-220, 1993. as high-voltage current stimulation4） report wound 4）Pamela E, Karen E, Campbell RN, et al：Electrical reduction. On these grounds these methods have been Stimulation TherapyIncreases Rate of Healing of assigned the recommendation rating of B. Pressure Ulcers in Community-Dwelling People With Of the studies examining the effect of phototherapy Spinal Cord Injury. Arch Phys Med Rehabil, 91（5）： on pressure ulcer, two randomized controlled trial5, 6） 669-678, 2010. and one case report7）specificallyexamine the use of 5 ）Schubert V：Effects of phototherapyon pressure

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ulcer healing in elderlypatients after a falling trauma. according to scale, rendering their relative utilityfor A prospective, randomized, controlled study. Photo- predicting, and therefore preventing, pressure ulcer dermatol Photoimmunol Photomed, 17（ 1 ）：32-38, occurrence unclear at best. On the other hand, the 2001. occurrence of pressure ulcers can be reduced if the 6 ）Dehlin O, Elmstahl S, Gottrup F：Monochromatic appropriate preventive interventions are conducted phototherapyin elderlypatients：A new wayof on the basis of information obtained from risk treating chronic pressure ulcers?. Aging Clin Exp assessment scales. Res, 15（3）：259-263, 2003. Another systematic review2）assessing the Braden, 7）Kurokawa M, Yamada N, Hanemori Y, et al：Effect of Norton, and Waterlow scales in terms of the para- linear polarized near infrared therapyfor pressure meters of clinical judgment and predictive validity ulcers. Geriat Med 40（ 8 ）：1165-1170, 2002. subjected the odds ratio of the three scales（4.08, 2.16, （Japanese） and 2.05, respectively）and the odds ratio of clinical 8）Nussbaum EL, Biemann I, Mustard B：Comparison of judgment（1.69）to meta-analysis and found that the ultrasound/ ultraviolet-C and laser for treatment of risk assessment scale was effective in predicting the pressure ulcers in patients with spinal cord injury. occurrence of pressure ulcers. Phys Ther, 74（9）：812-823, 1994. In summary, the reports given above demonstrate 9）Lucas C, van Gemert MJ, de Haan RJ：Efficacyof that the use of risk assessment scales with the low-level laser therapyin the management of stage Ⅲ appropriate interventions can reduce the rate of decubitus ulcers：A prospective, observer-blinded occurrence of pressure ulcers significantly. multicentre randomized clinical trial. Lasers Med Sci, References 18（2）：72-77, 2003. 10）Flemming K, Cullum N K, Cullum N, et al：Therapeu- 1）Deeks JJ：Pressure sore prevention: Using and evalu- tic ultrasound for pressure ulcer. Cochrane Database ating risk assessment tools. Br J Nurs, 5（ 5 ）： of Systematic Reviews. Issue 4, 2009. 313-320, 1996.（Level I） 11）Maeshige N, Terashi H, Sugimoto M, et al：Evalua- 2 ）Pancorbo-Hidalgo PL, Garcia-Fernandez FP, Lopez- tion of combined use of ultrasound irradiation and Medina IM, et al：Risk assessment scales for wound dressing on pressure ulcer. J Wound Care, 19 pressure ulcer prevention: a systematic review. J Adv （2）：63-68, 2010. Nurs, 54（1）：94-110, 2006.（Level I） 12）Salzberg CA, Stephanie A, Frnncisco JP, et al：The effects of non-thermal pulsed electromagnetic energy CQ 6.2：Which risk assessment scale should general- on wound healing of pressure ulcers in spinal cord- lybe used? injured patients：A randomized, double-blind study. ［ Recommendation ］Use of the Braden Scale is Wounds, 7（1）：11-16, 1995. recommended for most situations. ［Rating］B CQ 6 Risk assessment ［Analysis］The efficacy of the Braden Scale and CQ 6.1：Is risk assessment effective in predicting the Norton Scale for predicting pressure ulcer the development of pressure ulcers? occurrence was examined in a cohort studyusing two ［Recommendation］Use of risk assessment scales randomlyassigned groups, the\ turning group Sin is recommended for predicting pressure ulcer de- which subjectsSbodyposition was rotated, and the velopment. \non-turning groupS1）. The results showed that the ［Rating］B subjects in the non-turning group developed Grade II ［Analysis］Deeks1）published a systematic review or higher pressure ulcers at a significantlyhigher rate in which the validityof seven risk assessment scales, than the turning group. Further, a comparison of the namely, the Norton, Gosnell, Knoll, Braden, Waterlow, sensitivity, specificity, and the odds ratio of both PSPS, and Andersen scales, were evaluated in terms scales, when applied to the non-turning group, of the parameters of sensitivity, specificity, and demonstrated the equivalence of these two scales. pressure sore incidence rates. However, differences in An Internet search using\Braden ScaleSas the sample size and target population varied widely keyword produced a systematicreview 2） of nine

―G−57― ―69― studies dealing with the predictive validityof the References Braden Scale. However, due to the fact that the cut-off value varied widelyfrom 14〜20 points, no agreement 1）Kaigawa K, Moriguchi T, Oka H, et al：Analysis of could be found among these studies. the pressure ulcer risk in bedridden patients, Jpn Another article3）dealing with a cohort studyusing JPU, 8（ 1 ）：54-57, 2006.（ Level IV ）（ Japanese, the Braden Scale found that use of this scale enabled a English abstract） 50〜60% reduction in the incidence of pressure ulcers, as well as reductions in costs associated with specialty CQ 6. 4：Which risk assessment scale is recom- bed rentals and pressure reduction mattress overlays. mended for use with the elderly? In summary, the Braden Scale has proved effective ［Recommendation］ in both predicting pressure ulcer occurrence as well 1. The OH Scale maybe used with bedridden as reducing costs associated with pressure ulcer care. elderlypatients. As such, the adoption of this scale is recommended as ［Rating］C1 part of a prevention program. ［Recommendation］ 2. The K Scale maybe used with bedridden elderly References patients in hospital. 1）Defllor T, Grydonck MFH：Pressure Ulcers: valida- ［Rating］C1 tion of two risk assessment scales. J Clin Nurs, 14 ［Analysis］A case control report1）using the Ohura （3）：373-382, 2005.（Level IV） Risk Assessment Scale to evaluate four risk factors, 2）Brown SJ：The Braden Scale. A review of the re- namely, the state of consciousness, degree of sacral search evidence. Orthop Nurs, 23（1）：30-38, 2004. bonyprominence, edema, and articular contracture in （Level I） 95 pressure ulcer patients and 318 non-pressure ulcer 3）Bergstrom N, Braden B, Boynton P, et al：Using a patients found a significant difference between the research-based assessment scale in clinical practice. total average score for the pressure ulcer group（6.7） Nurs Clin North Am, 30（3）：539-551, 1995.（Level and that of the non-pressure ulcer group（3.4）. The IV） Ohura Risk Assessment Scale has since been revised and is now accepted as an highlyaccurate OH scale. CQ 6. 3：What method of assessment used for The reliabilityand predictive validityof the K Scale elderlypatients? have been examined in a prospective cohort studyof ［Recommendation］Assessing the risk factors for hospitalized bedridden elderlypatients 2）. The study pressure ulcer development maybe considered. found that in terms of reliability, the K Scale did not ［Rating］C1 require as high a level of experience or skill in the user ［ Analysis ］A retrospective cohort study1） of six as the Braden Scale. Further, an assessment of the risk factors（basic mobility, morbid bony prominence, predictive validityof the K Scale found the specificity articular contraction, malnutrition, skin moisture, of the underlying subscales to be 29.0% whereas that edema）stipulated bythe Ministryof Health, Labor, of the trigger subscales was 74. 2%. These results and Welfare in Supplement No. 4 of the Clinical demonstrated the clinical significance of the K Scale Practice for Pressure Ulcer Development（March 6, as an effective tool for predicting the development of 2006）studied the odds ratio of two groups, the non- pressure ulcers byobserving the changes in interface pressure ulcer group and the pressure ulcer group. pressure, moisture, and shear within a short period of The studyfound the odds ratio of the 173 bedridden time. subjects enrolled in the studyto be 4.0 for morbid References bonyprominence, 15.9 for articular contraction, 3.8 for malnutrition, and 3.1 for edema. Logistic regression 1）Fujioka M, Hamada Y：Usefulness of the Ohura risk found the odds ratio for articular contraction to be assessment scale for predicting pressure ulcer 11.2, the largest figure obtained, indicating the development, Jpn J PU, 6（ 1 ）：68-74, 2004.（ Level seriousness of this risk factor. IV）（Japanese, English abstract） 2）Okuwa M, Sanada H, Sugama J, et al：The Reliability

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and Validityof the K Scale for Predicting Pressure rit（ hemoglobin ）. A retrospective cohort study1） of Ulcer Development for the Elderly. Jpn J PU, 3（1）： the efficacyof this scale for pressure ulcer risk 7-13, 2001.（Level IV）（Japanese, English abstract） assessment in spinal cord injurypatients reported a high degree of reliabilityand validity.However, it CQ 6. 5：Which risk assessment scale is recom- should be borne in mind that as no similar studyhas mended for pediatric patients? been conducted in Japan, results mayvarywhen the ［Recommendation］The Braden Q Scale maybe scale is used with Japanese subjects. considered for risk assessment in pediatric patients. References ［Rating］C1 ［Analysis］A prospective cohort study1） was con- 1）Salzberg CA, Byrne DW, Cayten CG, et al：A new ducted with 332 pediatric in-patients with acute pressure ulcer risk assessment scale for individuals diseases（21 days old to 8 years old）to determine the with spinal cord injury. Am J Phys Med Rehabil, 75 predictive validityand cut-off value for the Braden Q （2）：96-104, 1996.（Level IV） Scale. For a cut-off point of 16 or lower, the sensitivity was 88%, the specificitywas 58%, the positive CQ 6. 7：Which risk assessment scale is recom- predictive value was 15%, the negative predictive mended for subjects in a home-care setting? value was 98%, and the likelihood ratio was 2.11. This ［Recommendation］A pressure ulcer risk assess- studysupports the efficacyof the Braden Q Scale as ment scale specificallydesigned for patients in a home equivalent to that of the Braden Scale used with adult care setting maybe used. subjects. ［Rating］C1 The Braden Q Scale is used bythe WOCN Clinical ［Analysis］The Pressure Ulcer Risk Assessment Practice Guideline2） as a pediatric risk assessment Scale for the Home Care Setting（home care setting scale. version of the K Scale）combines the K Scale with care capacityassessment. A prospective cohort References study1） using this scale rated its predictive validity 1）CurleyMAQ, Razmus IS, Roberts KE, et al：Predict- veryhighly.However, as this studywas conducted in ing pressure ulcer risk in pediatric patients : The a medium-sized city, differences in results may be Braden Q Scale. Nurs Res, 52（ 1 ）：22-33, 2003. expected due to variations in familystructure and （Level IV） care capacity. These considerations need to be borne 2 ）Wound Ostomyand Continence Nurses Society： in mind before using this scale. Guideline for Prevention and Management of Press- References ure Ulcers, 4 , WOCN Society, Mount Laurel, NJ,2010. 1）Murayama S, Kitayama Y, Okuwa M, et al：Develop- CQ 6. 6：Which risk assessment scale is recom- ment of a pressure ulcer risk assessment scale for the mended for spinal cord injurypatients? home-care setting. Jpn J PU, 9（ 1 ）：28-37, 2007. ［Recommendation］The SCIPUS scale maybe con- （Level IV）（Japanese, English abstract） sidered for risk assessment in spinal cord injury patients. CQ 7 Skin assessment ［Rating］C1 CQ 7.1：How can the depth of pressure ulcers be ［Analysis］The Spinal Cord Injury Pressure Ulcer predicted? Scale（ SCIPUS ）comprises 15 parameters: level of ［Recommendation］ activity, mobility, complete spinal cord injury, urine 1. The prediction of d1 pressure ulcer prognosis incontinence or constantlymoist, autonomic dysrefle- maybe based on the presence of double erythema xia or severe spasticity, age, tobacco use/smoking, （graduated redness）awayfrom a bonyprominence. pulmonarydisease, cardiac disease or abnormal ECG, ［Rating］C1 diabetes or hyperglycemia, renal disease, impaired ［Recommendation］ cognitive function, internment in a nursing home or 2. Ultrasonographymaybe used. hospitalization, albumin or total protein, and hematoc- ［Rating］C1

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［Recommendation］ 2 ）Aoi N, Yoshimura K, Kadono T, et al：Ultrasound 3. The ABI（ankle brachial index）maybe used to assessment of deep tissue injuryin pressure ulcers: predict the depth of pressure ulcers in the heel region. Possible prediction of pressure ulcer progression. ［Rating］C1 Plast Reconstr Surg, 124（2）：540-550, 2009.（Level ［ Analysis ］Sato, et al.1） have examined the de- V） velopment of non-blanchable erythema characterizing 3）Okuwa M, Sanada H, Sugama J, et al：Relationship Stage I pressure ulcers（NPUAP）in order to deter- between heel pressure ulcer severityand the ankle mine the utilityof clinical signs for pressure ulcer brachial index among bedfast elderlypatient. Jpn J P prognosis. From their observations, theyconcluded U，9（ 2 ）：177-182，2007.（ Level V ）（ Japanese, that the presence of double erythema（ graduated English abstract） redness ）, non-blanchable erythema confirmed by glass plate compression, erythema away from a bony CQ 7.2：How can redness/d1 stage pressure ulcer prominence, or expanding erythema predicted the be identified? development of tissue defects penetrating to the ［Recommendation］The transparent disk method dermis or even to underlying tissue. In particular, the or the finger method maybe considered. prognostic value of double erythema and erythema ［Rating］C1 awayfrom a bonyprominence for Stage I pressure ［Analysis］Acontrolled studybyVanderwee et al. ulcers was extremelyhigh, and helpful in predicting examined the reliabilityand diagnostic accuracyof the deterioration of d1 pressure ulcers. the transparent disk methed and the finger method In their studyof 12 cases, Aoi, et al. determined that for identifying Stage I pressure ulcers（EPUAP）1）. the level of deep tissue injurycould be predicted on The concordance rate of the two methods was higher the basis of an initial macroscopic observation of the than 90%, and CohenSs k co-efficient was higher than 0. patient and ultrasound findings2）. The studyrelied on 6, both indicating a high level of agreement. In terms four types of images, among which those of the of diagnostic accuracyas well, these methods yielded discontinuous fascia and heterogeneous hypoechoic a veryhigh degree of agreement irrespective of the areas had greatest diagnostic value. Further, ultraso- attending nursesSlength of experience. nographyproved useful for predicting tissue loss in Although at present there are no further high- cases where the depth of the pressure ulcer was evidence-level reports on the topic, both of the otherwise unclear. methods discussed here, namelythe transparent disk Another studyof 27 cases of pressure ulcer in the method and the finger method, as well as palpation, heel region examined the relationship between ABI can be considered for use in identifying redness/d1 （ Ankle Brachial Index ）findings at the initial ex- pressure ulcer because of the ease with which they amination and the final stage of pressure ulcer can be performed in a clinical setting. development3）. The ABI value for d1 and d2 pressure References ulcers in the heel region was 0.87, and 0.48 for wounds of level D3 or deeper in the heel region. The ROC 1）Vanderwee K, Grypdonck M, De Bacquer D, et al： analysis yielded an ABI outlier value of 0.6. The ABI The reliabilityof two observation methods of can be used to predict the depth of pressure ulcers in nonblanchable erythema, Grade 1 pressure ulcer. the heel region. Appl Nurs Res, 19（3）：156-162, 2006.（Level V） In conclusion, the accuracyof the prognosis of pressure ulcer progression can be increased through CQ 7. 3：Which methods can be used to identify close observation of erythema and the use of methods deep tissue injury（DTI）? such as ultrasonographyand ABI. ［Recommendation］ 1. Palpate the area to see whether pain, induration, References edema, or changes in skin temperature（ warm or 1）Sato M, Sanada H, Konya C, et al：Prognosis of stage I cool ）are present in comparison with the adjacent pressure ulcers and related factors. Int Wound J, 3 tissue. （4）：355-362, 2006.（Level V） ［Rating］C1

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［Recommendation］ occurrence of superficial pressure ulcers（ partial 2. Consider using ultrasonography. thickness wounds）. One randomized controlled study ［Rating］C1 compared the severityof pressure ulcers in inconti- ［Analysis］According to the NPUAP classification, nent patients following the use of soap or a mildly a suspected DTI is categorized as a\ purple or acidic cleansing agent1）. The results of this study maroon localized area of discolored intact skin or indicated a significant reduction in the occurrence of blood-filled blister due to damage of underlying soft Grade I pressure ulcers（pressure ulcers without skin tissue from pressure and/or shear. The area maybe defect）following the use of the mildlyacidic cleans- preceded by tissue that is painful, firm, mushy, boggy, ing agent. Two non-randomized clinical trials2, 3） and warmer or cooler as compared to adjacent tissue. S one historical control study4）examined the incidence Although the NPUAP advisorypanel states that the of pressure ulcers after cleansing only, or after the extent of deep soft tissue damage maybe difficult to application of skin emollients to the anal and genital detect from skin surface appearance, theydiscuss areas and to the peripheral skin. In both groups the changes in skin sensation and assessment bypalpa- incidence of pressure ulcers declined; in one study, tion as valid clinical findings1）. The clinical findings however, no statisticallysignificant difference was from palpation mayprovide useful information for reported3）. A before-and-after comparison of 136 identifying DTI. subjects interned in a long-term care facilityfound Ultrasonographycan be used as an objective means that the number of cases of skin trouble declined from of assessing DTI, according to one case report2）. The 68 to 40 subjects, while the rate of occurrence of Stage use of the CT scan, MRI, or ultrasonography, in I and II pressure ulcers declined from 19.9% to 8.1% addition to macroscopic observation and palpation, is （p ＜ 0.01）5）. Some of the skin care products men- recommended for an objective assessment of the tioned in the sources cited are unavailable here in condition. Of these various methods, onlyultraso- Japan although comparable products can be obtained. nographyis mentioned in connection with pressure On the basis of the above data, the application of ulcer assessment. skin emollients to the anal/ genitalia area to the peripheral skin after cleansing with an appropriate References cleansing agent is assigned a recommendation rating 1）Black J, Baharestani MM, Cuddigan J, et al：National of C1. Pressure Ulcer AdvisoryPanel. National Pressure References Ulcer AdvisoryPanelSs update pressure ulcer staging system. Adv Skin Wound Care, 20（ 5 ）：269-274, 1 ）Cooper P, GrayD：Comparison of two skin care 2007. regimes for incontinence. Br J Nurs, 10：S6, S8, S10 2）Nagase T, Koshima I, Maekawa T, et al：Ultrasonog- passim 2001.（Level II） raphic evaluation of an unusual peri-anal induration: a 2 ）Thompson P, Langemo D, Anderson J, et al：Skin possible case of deep tissue injury. J Wound Care, 16 care protocols for pressure ulcers and incontinence in （8）：365-367, 2007.（Level V） long-term care : A quasi-experimental study. Adv Skin Wound Care, 18：422-429, 2005.（Level III） CQ 8 Skin care 3）Clever K, Smith G, Bowser C, et al：Evaluating the Preventive Care efficacyof a uniquelydelivered skin protectant and its CQ 8.1：What kind of skin care is recommended for effect on the formation of sacral/buttock pressure patients suffering from urinaryand/or fecal inconti- ulcer. OstomyWound Manage, 48（12）：60-67, 2002. nence in order to prevent development of pressure （Level III） ulcers? 4）DealeyC：Pressure sores and incontinenc e : a study ［Recommendation］After cleansing with an appro- evaluating the use of topical agents in skin care. J priate cleansing agent, skin emollients can be applied Wound Care, 4：103-105, 1995.（Level III） to the anal/genital area and to the peripheral skin. 5）Hunter S, Anderson J, Hanson D, et al : Clinical Traial ［Rating］C1 of a prevention and treatment protocol for skin ［ Analysis ］Incontinence is associated with the breakdown in two nursing homes. J Wound Ostomy

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Continence Nurs, 30（5）：250-258, 2003.（Level III） recommended for application to the sacral area in patients who will undergo surgeryin a supine CQ 8. 2：What type of preventive skin care is position; Rating C1. However, it should be noted that recommended for use on bonyprominences in elderly this form of treatment is not covered byJapanese patients? National Health Insurance. ［ Recommendation ］Transparent film dressings References and other dressings with a low-friction external surface are recommended. 1）Imanishi K, Morita K, Matsuoka M, et al：Prevention ［Rating］B of postoperative pressure ulcer bya polyurethane ［ Analysis ］According to one study, transparent film patch. J Dermatol, 33（ 3 ）：236-237, 2006. film dressings applied to the sacral area resulted in a （Level II） significant decrease in the rate of occurrence of pressure ulcers1）. Another studyusing both smooth CQ 8.4：What kind of skin care is recommended for surface dressings and transparent film dressings on non-invasive ventilation patients to prevent pressure the left and right sides of the greater trochanter found ulcer formation at the face mask contact site? an absence of pressure ulcer formation in both groups, ［Recommendation］A transparent film dressing or and a significantlylower incidence of non-blanchable a hydrocolloid dressing may be used for this purpose. erythema in the low-friction external surface dressing ［Rating］C1 group2）. ［ Analysis ］Weng examined the rate of pressure ulcer occurrence in 90 non-invasive ventilation References patients1）. The subjects were divided into three 1 ）Ito Y, Yasuda M, Yone J, et al：Polyurethane film groups, namelythe control group and the transparent dressing applied to the sacral area for prevention of film and hydrocolloid dressing groups and the rate of pressure ulcers. Jpn J PU, 9（1）：38-42, 2007.（Level occurrence of Stage I pressure ulcers among them IV）（Japanese English abstract） was compared. The rate of pressure ulcer occurrence 2） Nakagami G, Sanada H, Konya C, et al：Evaluation of was 96. 7% in the control group, 53. 3% in the a new pressure ulcer preventive dressing containing transparent film dressing group, and 40% in the ceramide 2 with low frictional outer layer. J Adv Nurs, hydrocolloid dressing group, showing a significant 59（5）：520-529, 2007.（Level III） 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 have previouslybeen cited as a matter of ［ Analysis ］In a randomized controlled trial, Im- concern. The present guidelines have therefore anishi et al. compared the rate of occurrence of post- included discussion of this topic as well. operative pressure ulcers in supine patients with and References without transparent film dressings1）. Of the 103 subjects without the dressings, 22 developed pressure 1 ）Weng MH：The effect of protective treatment in ulcers, whereas in the 98 subjects with dressings, only reducing pressure ulcers for non-invasive ventilation 10 developed pressure ulcers, demonstrating a patients. Intensive Crit Care Nurs, 24（5）：295-299, statisticallysignificant difference between the two 2008.（Level III） groups（p = 0.049）. However, in view of the fact that 2）Tanaka M, Sakaki Y：Prevention of pressure ulcer in the BMI of all of the subjects was within the normal the nose/cheeks due to mask application in non- range, the relevance of these results to patients with invasive positive pressure ventilation -Effects of the pronounced bonyprominences cannot be ascertained. use of a skin barrier-. Jpn J PU, 10（1）：35-38, 2008. In summary, the transparent film dressing is （Level V）

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Care after occurrence 3）Ishikawa S, Togashi H, Tamura S, et al：Influence of CQ 8.5：How should the skin surrounding a press- new skin cleanser containing synthetic pseudo- ure ulcer be cleansed in order to promote pressure ceramide on the surrounding skin of pressure ulcers. ulcer healing? Jpn J PU, 5（3）：508-514, 2003. ［Recommendation］Cleansing with a mildlyacidic cleansing agent maybe considered. CQ 8.6：In cases with urinaryand/or fecal inconti- ［Rating］C1 nence, what kind of skin care is recommended to ［Analysis］Skin surrounding a pressure ulcer con- promote pressure ulcer healing? tains insoluble proteins, lipids and other contaminants, ［Recommendation］Skin emollients can be applied and therefore requires cleansing in the same manner to the peripheral skin after cleansing with an as healthyskin 1）. One studycomparing the rate of appropriate cleansing agent. healing in pressure ulcers before and after a regimen ［Rating］C1 of cleansing peripheral skin using either a sterile ［Analysis］Two non-randomized controlled studies saline solution or a mildlyacidic cleansing agent found comparing healing time between a control group that the latter shortened the healing time of pressure whose skin was cleansed using a cleansing agent only ulcers at anystage 2）. Further, the rate of healing and an experimental group whose skin was covered among cases of Stage II pressure ulcers cleansed with with a protective cream after cleansing found that the mildlyacidic cleansing agent was 1.79 times faster healing time shortened and the healing rate improved than the sterile saline solution group. significantlyin the latter group 1, 2）. As yet there are no reports as to the specific types On the basis of these data, in order to promote of cleansing agents that promote healing in pressure pressure ulcer healing, the application of skin ulcers. However, one studycomparing the effect of a emollients on the peripheral skin is recommended in mildlyacidic cleansing agent and a mildlyacidic cases of fecal and/or urinaryincontinence, as with ceramide-containing cleansing agent reported a prevention of pressure ulcers, following cleansing reduction in the quantityof scales and microbes as with an appropriate cleansing agent. well as an increase in the amount of ceramide after References use of the mildlyacidic ceramide-containing cleansing agent3）. Accordingly, if maintaining the normal 1 ）Thompson P, Langemo D, Anderson J, et al：Skin physiological function of the skin is sufficient to care protocols for pressure ulcers and incontinence in prevent epithelialization of the skin surrounding the long-term care : a quasi-experimental study. Adv Skin wound, a mildlyacidic cleansing agent containing Wound Care, 18（8）：422-429, 2005. skin-protective agents is the best option. Absent this 2）DealeyC：Pressure sores and incontinenc e : a study option, a mildlyacidic cleansing agent is preferred to evaluating the use of topical agents in skin care. J conventional soap. In summary, a mildly acidic Wound Care, 4（3）：103-105, 1995. cleansing agent is the preferred option for cleansing 3）Bale S, Tebble N, Jones V, et al：The benefits of the skin surrounding a pressure ulcer wound in order implementing a new skin care protocol in nursing to promote wound 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］Consider repositioning the pa- microbial flora. OstomyWound Manage, 51（1）：50- tient at least everytwo hours. 59, 2005. ［Rating］C1 2）Konya C, Sanada H, Sugama J, et al：Dose the use of a ［Analysis］One systematic review dealing with the cleanser on skin surrounding pressure ulcer in order frequencyof bodyrepositioning demonstrated that people healing?. J wound care, 14（4）：169-171, 2005. under optimal conditions provided bythe use of a （Level III） support surface, bodyrepositioning performed every

―G−63― ―75― four hours was equallyeffective for preventing been published to date dealing with bodyreposition- pressure ulcer formation as repositioning everytwo ing for nursing home residents1, 2）. The subjects were hours1）. Further, the NPUAP/EPUAP guidelines divided into the 2-hour and 3-hour repositioning state that,\ Repositioning frequencywill be deter- groups using a standard hospital mattress and a 4- mined bythe individual Ss tissue tolerance, his/her hour and 6-hour repositioning group using a support level of activityand mobility,his/her general medical surface（ visco-elastic foam mattress 15cm in thick- condition, the overall treatment objectives, and ness）, and the rates of pressure ulcer development assessments of the individualSs skin conditionS2）. The among them was assessed1）. As a result, the 4-hour WOCN guidelines recommend to schedule regular repositioning group showed a significantlylower rate repositioning and turning for bed and chair bound of Grade II pressure ulcer development（p = 0.002）. individuals3）. Neither guidelines state specific inter- Further, a studycomparing pressure ulcer formation vals at which the patient Ss bodyshould be reposi- rates between a control group（comprised of subjects tioned; nor are there anystudies conducted in Japan laterallypositioned for 2 hours and supinelyposi- to date which address this question with respect to tioned for 4 hours ）and the experimental group patients at high risk of developing pressure ulcers. In （comprised of subjects laterallypositioned for 4 hours view of the fact that the present guidelines aim to and supinelypositioned for 4 hours）using a visco- address issues relating to pressure ulcer care and elastic mattress 7cm in thickness failed to demons- management in a diversityof care settings, such as trate a significant difference in pressure ulcer home, institution, and hospital, we recommend that development rate among these groups2）. The subject the patient be repositioned at least everytwo hours. enrolled in these studies, however, differ in respect to their bodysize, weight, and other factors, from their References counterparts in Japan, and for this reason the 1）Krapfl LA, GrayM：Does regular repositioning pre- application of the methods outlined in the aforemen- vent pressure ulcers?. J Wound OstomyContinence tioned studies to patients in Japan mayentail some Nurs, 35（6）：571-577, 2008.（Level I） risk, and offer no guarantee of yielding similar results. 2）National Pressure Ulcer and AdvisoryPanel and Eu- On the other hand, a case controlled studydealing ropean Pressure Ulcer AdvisoryPanel：Prevention with patients in a convalescent hospital assessed the and treatment of pressure ulcers, clinical practice development of erythema among patients supinely guideline, National Pressure Ulcer AdvisoryPanel, positioned on a double-layer air-cell mattress Washington DC, 2009. overlay3）. The patients were repositioned at intervals 3 ）Wound, Ostmyand Continence Nurses Society： of two hours or greater, and their skin was observed Guideline for prevention and management of press- at 2, 4, and 5 hours from commencement of the ure ulcers. WOCN clinical practice guidelines no. 2 experiment for indications of erythema. As a result, 4 Glenview, IL, 2003. hours was found to be the upper limit at which patients could be maintained in one position without CQ 9.2：How frequentlyshould bed bound patient the development of erythema. After 5 hours, 50% of be repositioned when a support surface is being used? patients were found to have developed indications of ［Recommendation］ erythema. 1. When a visco-elastic foam mattress is being used, The NPUAP/EPUAP guidelines state that,hFre- consider repositioning the patient at least everyfour quencyof repositioning will be influenced byvariables hours. concerning the individual and support surface in ［Rating］C1 usei4）. ［Recommendation］ Because both evidence sources involve a specific 2. When a double-layer air-cell mattress overlay is group of subjects using a specific type of support being used, consider repositioning the patient at least surface, and therefore provide findings with limited everyfour hours. applicability, they are assigned the recommendation ［Rating］C1 rating of C1. ［Analysis］Two randomized controlled trials have

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wishes of the patient or the physical stature of the References patient, rather than adhering strictlyto the 30-degree 1）Defloor T, De Bacquer D, Grypdonck MH, et al：The tilted side-lying position; recommendation rating C1. effect of various combinations of turning and pressure References reducing devices on the incidence of pressure ulcers. Int J Nurs Stud, 42（1）：37-46, 2005.（Level II） 1）Young T：The 30°tiltposition vs the 90°lateraland 2）Vanderwee K, Grypdonck MH, De Bacquer D, et al： supine position in reducing the incidence of non- Effectiveness of turning with unequal time intervals blanching erythema in a hospital inpatient population: on the incidence of pressure ulcer lesions. J Adv Nurs, A randomized controlled trial. J Tissue Viability, 14 57（1）：59-68, 2007.（Level II） （3）：88-96, 2004.（Level II） 3）Nakashima F, Toyoda T：Evaluation of pressure ulcer development in patients who underwent positional CQ 9.4：How can patients in intensive care be repo- changes at intervals of 2 hours or more. JpnJPU,5 sitioned in order to prevent pressure ulcer formation? （1）：37-41, 2003.（ Level IV ）（ Japanese English ［ Recommendation ］The patient maybe reposi- abstract） tioned in an electric rolling hospital bed. 4）National Pressure Ulcer and AdvisoryPanel and Eu- ［Rating］C1 ropean Pressure Ulcer AdvisoryPanel：Prevention ［Analysis］Patients in intensive care with unstable and treatment of pressure ulcers, clinical practice vital signs pose a greater difficultyto the attending guideline, National Pressure Ulcer AdvisoryPanel, nurse who must periodicallyreposition the patient. A Washington DC, 2009. historical cohort study1） conducted at a cardiac treatment center examined the rate of pressure ulcer CQ 9. 3：When repositioning bed bound patients, development among cardiac patients during the what positions should be undertaken to avoid period in which theywere repositioned manuallyat 2 pressure ulcer formation? hour intervals bynursing staff compared to the period ［Recommendation］A 30- and 90-degree angle for in which theywere repositioned in an electric rolling the laterallyrecumbent position maybe considered. hospital bed. The results indicated that the rate of ［Rating］C1 pressure ulcer development in the period during ［Analysis］A randomized controlled trial involving which the electric rolling hospital bed was used was elderlypatients interned in an acute phase care significantlylower（p ＜ 0.001）. Because the electric hospital compared the rate of pressure ulcer develop- rolling hospital bed featured in the studywere ment between the experimental group, comprised of equipped with various functions, it is difficult to patients in a 30-degree tilted side-lying position and establish the efficacyof anysingle one of these two control groups, one comprised of patients in a functions for the prevention of pressure ulcers. In supine position plus 90-degree side-lying position, and Japan, due to cost considerations and the difficultyof the other, comprised of patients in onlya supine technical maintenance, few health care institutions are position. The studyfound no significant difference in equipped with high-tech rolling hospital beds. For the the rate of pressure ulcer development among these above reasons, the use of electric rolling hospital bed groups. However, more than 80% of subjects in the 30- is assigned the recommendation rating of C1. degree tilted side-lying position group complained of References discomfort. The 30-degree tilted side-lying position requires 1）Gregor S, Kerstin F, Enrico Z, et al：Kinetic therapy patients to support their bodyweight with their reduces complications and shortens hospital stayin gluteal muscles. However, due to the decline in patients with cardiac shock, a retrospective analysis. nutritional health as well as muscular atrophy Eur J Cardiovasc Nurs, 6（1）：40-45, 2007.（Level resulting from inactivity, bed bound patients in Japan IV） tend to show more prominent bonyprominences in the buttock region. For this reason, the bodyposition CQ 9. 5：What positions should be undertaken to of the patient should be chosen in accordance with the promote healing in patients with pressure ulcers in

―G−65― ―77― 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.（Level III） vated position maybe undertaken. ［Rating］C1 CQ 10 Support surfaces ［ Analysis ］Two non-randomized self-controlled CQ 10.1：Should support surfaces be used to lower studies conducted in Japan have addressed the the incidence of pressure ulcers? question of which bodypositions are best for patients ［ Recommendation ］Use of support surfaces is with pressure ulcers in the gluteal region. One study1） stronglyrecommended in order to lower the inci- compared the shape of the wounds after a period in dence of pressure ulcers. 30- and 90-degree side-lying positions and found that a ［Rating］A total of 5 wounds demonstrated a change in shape, ［Analysis］There are five systematic reviews and while 4 did not（changes in cross-sectional area of the meta-analyses which compare the use of standard wound in the\ changed Sgroup; 72. 3: in the\ non- hospital mattresses with other types of support changedSgroup; 8.2, p = 0.04）. Similar results were surface1−5）. All of these studies found that support found with the 30-degree head-of-bed elevated posi- surfaces are significantlysuperior to standard hospital tion group. The ratio of change in the cross-sectional mattresses in preventing pressure ulcers. On the area of the wounds was statisticallysignificant, at 0.16 basis of this evidence, the use of support surfaces has for the\changed,Sand 1.36 for the\non-changed,S been assigned a recommendation rating of A. groups（p = 0.02）. In a separate study2） measuring Furthermore, the NPUAP/EPUAP guidelines6）state, pressure on healthyskin and the thickened tissue of hDo not base the selection of support surfaces solely the wound peripheryin patients in a 30-degree tilted on the perceived level of risk for pressure ulcer side-lying position and 30-degree head-of-bed elevated development or the category/stage of any existing position demonstrated significantlyhigher maximal pressure ulcersiand,hChoose a support surface that pressure（p = 0.01, p = 0.05）as well as significantly is compatible with the care settingiunderscoring the higher average pressure（p = 0.01, p = 0.03）on the need to consider pressure ulcer risk, patients S thickened tissue. Both above-mentioned studies ex- preferences, and care settings when choosing a amined pressure ulcers among bed bound elderly support surface. patients. References The so-called 30-degree rule was become wide- spread as a means of preventing pressure ulcers, and 1）Cullum N：Support surface for pressure ulcer pre- has also been applied to the management of existing vention. EBM reviews Cochrane Database Syst Rev, pressure ulcers. However, it should be borne in mind 3：CD001735, 2004.（Level I） that this rule mayhave the effect of prolonging 2）ReddyM, Gill SS, Rochon PA：Preventing pressure recoveryif applied in all cases regardless of the ulcers, a systematic review. JAMA, 296（ 8 ）：974- physical stature of the patient. We recommend that a 984, 2006.（Level I） bodyposition most suitable to the physicalstature and 3）Whittemore R：Pressure-reduction support surfaces： wound condition of the patient be chosen, rather than A review of the literature. J Wound Ostomy adhering strictlyto the 30-degree rule. On the basis of Continence Nurs, 25（1）：6-25, 1998.（Level I） these considerations, we have assigned these evi- 4）Nicosia G：The effect of pressure-relieving surfaces dence sources a recommendation rating of C1. on the prevention of heel ulcers in a varietyof settings：a meta-analysis. Int Wound J, 4（3）：197- References 207, 2007.（Level I） 1）Kitagawa A, Konya C, Omote S, et al：Effects of 5 ）McInnes E, Jammali-Blasi A, Bell-Syer SE, et al： changing bodyposition on pressure ulcer morphology Support surfaces for pressure ulcer prevention. and blood circulation. JpnJPU,5（3）：494-502, Cochrane Database Syst Rev, 13（ 4 ）：CD001735. 2003.（Level III）（Japanese English abstract） 2011.（Level I） 2）Okuwa M, Sugama J, Sanada H, et al：Measuring the 6）National Pressure Ulcer and AdvisoryPanel and Eu-

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ropean Pressure Ulcer AdvisoryPanel：Prevention for prevention of pressure ulcers in elderlyindi- and treatment of pressure ulcers, clinical practice viduals? guideline. National Pressure Ulcer AdvisoryPanel, ［Recommendation］ Washington DC, 2009. 1. Recommend using a double-layer air-cell mat- tress. CQ 10.2：Which support surface is recommended ［Rating］B for completelyimmobile patients? ［Recommendation］ ［Recommendation］ 2. An alternating-pressure air mattress overlay/ 1. Recommend using an alternating-pressure air replacement, air-filled mattress overlay, or foam mattress overlay/ replacement. mattress mayalso be used. ［Rating］B ［Rating］C1 ［Recommendation］ ［Analysis］Six randomized controlled studies pub- 2. Consider using a foam mattress replacement. lished outside Japan1−6）, and one randomized control- ［Rating］C1 led studypublished in Japan 7）, have examined the ［Analysis］The NPUAP/EPUAP guidelines endo- relationship between various types of support sur- rse the use of alternating pressure air mattresses faces and the incidence of pressure ulcer development overlays/replacement for patients who cannot be among elderlypatients. repositioned frequently, adding that this method is The studies published outside Japan examined the 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 and 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 a guideline. National Pressure Ulcer AdvisoryPanel, randomized controlled trial involving Japanese sub- Washington DC, 2009. jects, double-layer air-cell mattress, single-layer air- 2）Vyhidal SK, Moxness D, Bosak KS, et al：Mattress cell mattress overlay, and standard hospital mattress replacement or foam overlay? A prospective study on were associated with a pressure ulcer development the incidence of pressure ulcers. Appl Nurs Res, 10 incidence of 3.4%, 19.2%, and 37.0%, respectively, with （3）：111-120, 1997.（Level II） double-layer air-cell mattress showing a significantly 3）Berthe JV, Bustillo A, Melot C, et al：Does a foamy- lower incidence than the others（p ＜ 0.01）7）. The block mattress system prevent pressure sores? A same studyfound that the double-layerair-cell prospective randomized clinical trial in 1729 patients. mattress was similarlyeffective in a 45-degree head- Acta Chir Belg, 107（2）：155-161, 2007.（Level II） of-bed elevated position. On the basis of these results, the use of the double-layered air-cell mattress has CQ 10.3：Which support surface is recommended been assigned a recommendation rating of B.

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For elderlypatients, the risk of pressure ulcers, examining the incidence of pressure ulcer among especiallyin areas with bonyprominences, and the patients admitted to the ICU or CCU6−9）. particular care setting should also be considered when The studies conducted outside Japan examined the choosing the most appropriate support surfaces. efficacyof low air-loss beds, alternating-pressure air mattress overlays, air-filled mattress overlays, water References mattresses, and air-filled mattress replacement in 1）Bliss MR：Preventing pressure sores in elderlypati- pressure ulcer prevention. The efficacyof low air-loss ents：a comparison of seven mattress overlays. Age beds varied according to study1, 2） while air-filled Ageing, 24（4）：297-302, 1995.（Level II） mattress overlays and water mattresses showed no 2）Exton-Smith AN, Overstall PW, Wedgwood J, et al： significant difference when compared with other Use of\air wave systemSto prevent pressure sores control mattresses4）. Although the air-filled mattress in hospital. Lancet, 1（ 8284 ）：1288-1290, 1982. replacements were associated with a significantly （Level II） lower incidence of pressure ulcer development than 3）Lazzara DJ, Buschmann MT：Prevention of pressure the controls5）, these results could not be corroborated ulcers in elderlynursing home residents-：Are byanystudies done in Japan 6）. On the basis of the special support surfaces the answer?. Decubitus, 4 evidence presented above, the recommendation （4）：42-48, 1991.（Level II） rating of C1 has been assigned to the items discussed 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.（Level II） 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.（Level II） 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.（Level II） （ 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.（Level II） 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.（Level II） ［Rating］C1 2）Theaker C, Kuper M, Soni N：Pressure ulcer preven- ［Analysis］There are five randomized controlled tion in intensive care- a randomized control trial of trials conducted outside Japan1−5）, and four rando- two pressure reliving devices. Anaesthesia, 60（4）： mized controlled trials conducted within Japan 395-399, 2005.（Level II）

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3）Gebhardt KS, Bliss MR, Winwright PL, et al：Pressure- used. relieving supports in an ICU. J Wound Care, 5（3）： ［Rating］C1 116-121, 1996.（Level II） ［Recommendation］ 4）Sideranko S, Quinn A, Burns K, et al：Effects of posi- 4. The bead bed system may be used during tion and mattress overlayon sacral and heel pressure surgeryfor patients undergoing surgeryto repair in a clinical population. Res Nurs Health, 15（ 4 ）： femoral-neck fracture. 245-251, 1992.（Level II） ［Rating］C1 5）Takala J, Varmavuo S, Soppi E：Prevention of press- ［Recommendation］ ure sores in acute respiratoryfailure：a randomized 5. Thermoactive viscoelastic foam overlaymaybe controlled trial. Clin Intensive Care, 7：228-235, 1996. used for patients who will undergo cardiac surgery. （Level II） ［Rating］C1 6）Fujioka A, Taneike M, Tanaka T, et al：Comparison ［Analysis］There are one systematic review1）one of two support surfaces from the point of the meta-analysis2） and six randomized controlled incidence of pressure ulcers and QOL of ICU patients. trials3−8） which compare pressure ulcer development Jpn J Nurs Soc: Adult Nursing I：149-151, 1998. incidence among perioperative patients. （Level II）（Japanese） The systematic reviews reported that the use of 7）Fujikawa Y, Terashi H, Sanada H：The assessment support surfaces on the operating table had a positive of low air pressure mattress for ICU Patients; effect on lowering the incidence of pressure ulcers, Incidence of pressure ulcers and total cost. JpnJ P U, 3 but failed to mention which support surfaces were （1）：44-49, 2001.（Level II）（Japanese English ab- most effective in achieving this result. stract） 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 ） ： lays/ replacement, bead bed system, and thermoac- 42-47, 1995.（Level II）（Japanese） tive viscoelastic foam overlay. The gel or visco-elastic 9）Sugama J, Sanada H, Taneike M, et al：Prevention of pad were associated with a significantlylower pressure sores for patients in intensive care unit − incidence of pressure ulcer development than the Incidence of pressure sores using two types of control mattresses3, 4）. The results of using the mattres −, ICU and CCU, 19（ 2 ）：147-152, 1995. alternating-pressure air mattress overlays/ replace- （Level II）（Japanese） ment during surgery, however, varied according to studyand no clear conclusion could be reached CQ 10.5：Which tools, including support surfaces, regarding its efficacyin preventing pressure are effective in preventing the development of ulcers5, 6）. Although a significantlylower incidence of pressure ulcers during perioperative periods? pressure ulcer occurrence（ 15. 6% ）was associated ［Recommendation］ with the use of the bead bed system than with the 1. Support surfaces on the operating table are controls, the bead bed system cannot be considered as recommended for patients at risk of developing an effect means of reducing pressure ulcer develop- pressure ulcers. ment due to the high rate of pressure ulcer ［Rating］B occurrence7）. Fechtinger et al. have reported that ［Recommendation］ there was no significant difference in efficacybetween 2. In addition to using support surfaces, visco- thermoactive viscoelastic foam overlayand the elastic pads or gel applied to the heel area, cubital control group8）. No randomized controlled studies region, and other areas with bonyprominences is examining these support surfaces have been con- recommended during operations. ducted in Japan. On the basis of these data, the use of ［Rating］B gel or visco-elastic pad has been given a recommenda- ［Recommendation］ tion rating of B, while the other types of support 3. During and after operations, an alternating- surface have been assigned a rating of C1. pressure air mattress overlays/replacement may be The use of this evidence in Japan should be

―G−69― ―81― preceded bya careful consideration of the surgical facilitate care for convalescent patients in a home- procedure involved, the surgical environment, and care setting? risk to the patient. The surgical procedures discussed ［Recommendation］An automatic turning air mat- in the above-mentioned studies involved maintaining tress maybe used. the lithotomyposition or supine position for three ［Rating］C1 continuous hours in general, vascular, gynecological, ［Analysis］In one self-controlled trial by Melland et cardiac, or femoral surgical procedures for treating al., patients in a home-care setting and a long-term femoral neck fractures. care facilityreported no difference in comfort levels when using an automatic turning air mattress than References when using conventional bedding. The same subjects 1）Cullum N：Support surface for pressure ulcer pre- also reported experiencing verygood qualityof sleep vention. EBM reviews Cochrane Database Syst Rev, （ p = 0. 024 ）. Furthermore, one in 17 subjects de- 3：CD001735, 2004.（Level I） veloped pressure ulcers in the four-week period 2 ）McInnes E, Jammali-Blasi A, Bell-Syer SE, et al： during which the automatic turning air mattress was Support surfaces for pressure ulcer prevention. used. A self-controlled trial conducted in Japan Cochrane Database Syst Rev, 13（ 4 ）：CD001735, reported that the caregiver Ss burden was lessened 2011.（Level I） and no pressure ulcers reported during a two-week 3）Schultz A, Bien M, Dumond K, et al：Etiologyand period in which 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.（Level II） order to facilitate the activityof caregivers in a home 4）Nixon J, McElvennyD, Mason S, et al：A sequential care setting and to improve the patientSs 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 patient Ss bodyis repositioned on a ulcers. Int J Nurs Stud, 35（ 4 ）：193-203, 1998. regular basis. （Level II） References 5）Aronovitch SA, Wilber M, Slezak S, et al：A com- parative 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. 18（4）：65-70, 1999.（Level III） （Level II） 2）Futamura M, Sugama J, Sanada H, et al: A clinical 6）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 distribu- cell pulsating dynamic mattress system in the tion and caregiverSs burden in home cared elderly−. prevention of pressure ulcers in patients undergoing Jpn J Acad Gerontol Nurs, 10（ 2 ）：62-69，2006． cardiovascular surgery. Ostomy Wound Manage, 46 （Level III）（Japanese） （2）：46-55, 2000.（Level II） 7）Goldstone LA, Norris M, OSReillyM, et al：A clinical CQ 10.7：Which support surfaces provide the great- trial of a bead bed system for the prevention of est comfort both while awake and sleeping? pressure sores in elderlyorthopaedic patints. J Adv ［Recommendation］ Nurs, 7（6）：545-548, 1982.（Level II） 1. Using an alternating-pressure air mattress 8 ）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. For terminallyill patients, an alternating- II） pressure air mattress with automatic adjustment to the patient's weight and position maybe considered. CQ 10.6：Which support surfaces can be used to ［Rating］C1

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［Analysis］One systematic review1）and two rando- passage of time. One of the causes of the degradation mized controlled trials2, 3） conducted outside Japan of qualityis fatigue. Fatigue is seen when distortions have examined the qualityof sleep and comfort levels in the contours of the mattress remain even after the experienced bypatients who were used an weight or source of pressure has been removed. Two alternating-pressure air mattress replacement. The analytical epidemiological studies have examined the systematic review found that the comfort levels problem of fatigue in urethane foam mattresses1, 2）. reported bythe patients were significantlyhigher for These studies found that 66 urethane foam mattres- the alternating-pressure air mattress overlays/repl- ses 5〜10 years after their purchase had compressed acement than for the control group. Furthermore, the an average of 10.7 ± 6.0 mm（range 0-30 mm）from two- and four-cell types were considered more fatigue. Use of urethane foam mattresses which had comfortable1）. In addition, 18. 9% of patients com- compressed an average of 11mm as a result of fatigue plained about the alternating-pressure air mattress significantlyincreased interface pressure values replacement while 23. 3% complained about the compared with new mattresses（p ＜ 0.05）1）. Furth- alternating-pressure air mattress overlay, indicating a er, the studyexamined the degree of fatigue significantlylower number of complaints for the according to contact points on the bodyincluding the former（p ＜ 0.05）2）. Grindleyet al. surveyedtermin- buttocks, knees, shoulder joints, head, and heel, found al patients about their preferences and found that 62. that fatigue was most visible in the area of the 5% preferred the alternating-pressure air mattress mattress in direct contact with the buttocks（ p ＜ with automatic adjustment to the patientSs weight and 0.05）2）. position, 12.5% preferred the alternating-pressure air On the basis of these data, urethane mattresses mattress overlay, and 25.0% preferred the standard should be checked periodicallyfor signs of fatigue, mattress（p ＜ 0.05）3）. especiallyin the areas that come into frequent or When choosing a mattress, consider the patientsS prolonged contact with the buttocks. preferences as well as pressure ulcer development References risk and pressure ulcer stage. 1）Matsubara Y：Fatigue of foam mattress and inter- References face pressure in healthyvolunteers. Nursing, 27 1）Vanderwee K, Grypdonck M, Defloor T：Alternating （11）：88-93, 2007.（Level IV）（Japanese） pressure air mattresses as prevention for pressure 2 ）Heule EJ, Goossens RH, Mugge R, et al：Using an ulcers：a literature review. Int J Nurs Stud, 45（5）： indentation measurement device to assess foam 784-801, 2008.（Level I） mattress quality. Ostomy Wound Manage, 53（11）： 2 ）Nixon J, CrannyG, Iglesias C, et al：Randomized, 56-62, 2007.（Level I）（Level IV） controlled trial of alternating pressure mattresses compared with alternating pressure overlays for the CQ 10.9：Which support surfaces are recommen- prevention of pressure ulcers：PRESSURE（ press- ded for promoting healing in d1, d2, and D3〜D5 ure relieving support surfaces ）trial. BMJ, 332 pressure ulcers? （7555）：1413, 2006.（Level II） ［Recommendation］ 3）GrindleyA, Acres J：Alternating pressure mattres- 1. Use of an air-fluidized bed or low-air-loss bed is ses： comfort and qualityof sleep. Br J Nurs（Mark stronglyrecommended to promote healing in D3〜D5 Allen Publishing）, 5（21）：1303-1310, 1996.（Level pressure ulcers or pressure ulcers in multiple sites. II） ［Rating］A ［Recommendation］ CQ 10.8：What precautions should be taken when 2. Use of an alternating-pressure air mattress with using foam mattresses? automatic adjustment for the patientSs position and ［ Recommendation ］Monitor the deterioration of weight, an alternating-pressure large-cell ripple mat- the foam due to fatigue. tress, a double-layer air-cell mattress, or a low air ［Rating］C1 pressure mattress maybe considered to promote ［Analysis］Foam mattresses will degrade with the healing in d2 or deeper pressure ulcers.

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［Rating］C1 air-fluidized beds and low-air-loss beds is strongly ［Recommendation］ recommended for patients diagnosed with stage III or 3. Use of an air-filled mattress overlaymaybe IV, or D3〜D5 pressure ulcers or with pressure ulcers considered to promote healing in d1/2 pressure ulcers. in 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 patient Ss 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 patient Ss 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 five randomized controlled 1）National Pressure Ulcer and AdvisoryPanel and Eu- trials4−6, 8, 9） which found that the use of low-air-loss ropean Pressure Ulcer AdvisoryPanel：Prevention beds and air-fluidized beds was more effective for and treatment of pressure ulcers, clinical practice wound healing and contraction rates. The efficacyof guideline, National Pressure Ulcer AdvisoryPanel, alternating-pressure air mattress with automatic Washington DC, 2009. adjustment to the patient Ss position and weight 2）Wound Ostomyand Continence Nurses Society：Guide- function replacement was examined in a randomized line for prevention and management of pressure controlled trial involving patients who had received ulcers. WOCN clinical practice guideline；no. 2, flap surgeryfor pressure ulcers involing fascia, Glenview, IL, 2003. muscle and bone7） as well as in a randomized 3）WhitneyJ, Phillips L, Aslam R, et al：Guidelines for controlled trial involving stage II〜IV pressure ulcer the treatment of pressure ulcers. Wound Repair patients11）. Neither studyfound a significant differ- Regen, 14（6）：663-679, 2006. ence in effect between the bed type in question and 4）DayA, Leonard F：Seeking qualitycare for patients the controls. Bliss examined the efficacyof with pressure ulcers. Decubitus, 6（1）：32-43, 1993. alternating-pressure large cell ripple mattresses in a （Level II） randomized controlled trial involving stage II〜IV 5）Ferrell BA, Keeler E, Siu AL, et al：A randomized pressure ulcers and found that theywere significantly trial of low-air loss for treatment of pressure ulcers. more effective than the controls in promoting JAMA, 269（4）：494-497, 1993.（Level II） healing10）. On the other hand, Lazzara and Bushmann 6）Branom R, Rappl LM：hConstant force technologyi conducted a randomized controlled trial involving versus low-air-loss therapyin the treatment of state I and II pressure ulcer patients to examine the pressure ulcers. OstomyWound Manage, 47（ 9 ）： efficacyof air-filled mattress overlaysin promoting 38-46, 2001.（Level II） wound healing, and found no statisticallysignificant 7）Finnegan MJ, Gazzerro L, Finnegan JO, et al：Com- difference with the control groups12）. paring the effectiveness of a specialized alternating One historical controlled trial13） and one non- air pressure mattress replacement system and an air- controlled intervention study14） conducted in Japan fluidized integrated bed in the management of post- using stage II〜IV pressure ulcer patients found that operative flap patients：a randomized controlled pilot use of double-layer air-cell mattresses was more study. J Tissue Viability, 17（1）：2-9, 2008.（Level conducive to wound reduction than single-layer air- II） cell mattresses（p ＜ 0.05）13）. The low air pressure 8）Munro BH, Brown L, Heitman BB：Pressure ulcers, mattresses were also found to be more effective in one bed or another?. Geriatr Nurs, 10（4）：190-192, wound reduction and skin regeneration than air-filled 1989.（Level II） mattress overlays（p ＜ 0.05）14）. 9）Allman RM, Walker JM, Hart MK, et al：Air-fluidized On the basis of the data presented above, the use of beds or conventional therapyfor pressure sores. A

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randomized trial. Ann Int Med, 107（ 5 ）：641-648, ［Analysis］There are one randomized controlled 1987.（Level II） trials, one non-randomized controlled trial, one cohort 10）Bliss MR：Preventing pressure sores in elderlypati- study, and numerous case reports pertaining to ents：a comparison of seven mattress overlays. Age patient education. Ageing, 24（4）：297-302, 1995.（Level II） Instructions in repositioning including positioning, 11）Evans D, Land L, GearyA, et al：A clinical evaluation posture in using the wheelchair, and maintaining of the Ninbus 3 alternating pressure mattress correct sitting posture can be carried out to prevent replacement system. J Wound Care, 9（4）：181-186, the development of pressure ulcers. Further, the 2000.（Level II） measurement of pressure on various points of the 12）Lazzara DJ, Buschmann MT：Prevention of pressure bodyin turn leads to a better understanding of ulcers in elderlynursing home residents：Are special prevention as well as risk assessment, as reported in a support surfaces the answer?. Decubitus, 4（ 4 ）： number of published case studies1−3）. 42-48, 1991.（Level II） With regard to the efficacyof consultations with 13）Sato A, Sanada H, Sugama J, et al：The cost-effectiveness health care professionals, one randomized controlled of double-layer air-cell mattress for treating pressure trial has reported that knowledge of pressure ulcer ulcers. Jpn J PU, 8（2）：140-147, 2006.（Level III） prevention among the consultation group was higher （Japanese, English abstract） than among the control group as a result of monthly 14）Sanada H, Sugama J, Inagaki M, et al：Evaluation of a telephone contact after discharge in addition to newly-developed overlaying low pressure air- enhanced education given to the participants prior to mattress. Memoirs Health Sci Med Kanazawa Univ, discharge from hospital4）. However, the content of the 21：45-49, 1997.（ Level V ）（ Japanese, English ab- instruction was not specified nor was the statistical stract） significance documented. A non-randomized control- led trial5）comparing the efficacyof periodic interven- CQ 11 Patient education tion using video images as an educational tool, periodic CQ 11. 1：How can patients and their familyor telephone intervention, and telephone counseling as caregivers be educated to prevent the development freelychosen bythe patient, found that reports of or recurrence of pressure ulcers? pressure ulcers were highest among the video group ［Recommendation］ although the differences among the groups were not 1. Education/training in repositioning and using statisticallysignificant. The larger number of reports support surfaces can be carried out . among the video group is thought be due to the higher ［Rating］C1 rate of detection resulting from the increased ［Recommendation］ opportunities for visual contact with health care 2. Periodic telephone consultations with a health professionals. Further, the fact that pressure ulcers care professional and/or remote assessment of the detected among the video group were generallyless patientSs skin condition using electronic visual media advanced suggests that this mode of education/consu- maybe done. ltation was effective for earlydetection as well. ［Rating］C1 However, the remote video and telephone consulta- ［Recommendation］ tions featured in these two foreign studies are not 3. Education byan e-learning systemled bythe covered bythe National Health Insurance in Japan. health care professional maybe given. On the other hand, the viabilityof these methods is ［Rating］C1 being considered within the context of home nursing ［Recommendation］ care in Japan. 4. Education/training in anyor all of the following According to one cohort study, e-learning im- maybe given: the etiologyof ulcers, risk factors, plemented as a form of visual educational method staging, principles of wound healing, nutritional succeeded in raising awareness about pressure ulcers support, program of skincare and skin inspection, and among the participants, as demonstrated bytest management of incontinence. results6）. Although such methods do not directly ［Rating］C1 affect the rates of occurrence or healing of pressure

―G−73― ―85― ulcers among the participants, theyhave proved CQ 11. 2：How should patients/family/caregivers effective as educational tools. be educated/trained in the care of existing pressure The WOCN Clinical Practice Guidelines7） has a ulcers? section on education on the topics including the ［Recommendation］Consider informing patient/fa- etiologyof ulcers, risk factors, staging, principles of mily/caregiver how to contact an appropriate medical wound healing, nutritional support, program of center for help in the event the pressure ulcers skincare and skin inspection, and management of worsen. incontinence; however, these are based on expert ［Rating］C1 opinion. ［Analysis］A search of the currently existing sources In summary, education of the patient/family/care- under\ education Sfailed to produce anyreports giver, while succeeding in raising knowledge of based on clinical trials. The WOCN Practice Guideline pressure ulcers, failed directlyto affect the rates of recommends contacting a health care professional in occurrence or recurrence of pressure ulcers. the event of anycomplications, but this, too, is based on expert opinion. References At present, there are no clinical trials endorsing the 1）Sato M, Shimobatake Y, Nakahara K, et al：Case of methods described above. For this reason, educational spinal cord injuryrecovered pressure ulcer of and/or training methods endorsed onlybyexpert hipbone. Leaving hospital adjustment for recurrence opinion can be considered. prevention. Jpn Adn Ⅱ, 36：390-391, 2005.（ Level References V）（Japanese） 2）Hori M, Kakuya K, Orikasa H, et al：Management of a 1 ）Wound Ostomyand Continence Nurses Society： paraplegic patient who suffers from repeated ischial Guideline for Prevention and Management of Press- pressure ulcers. Jpn J PU, 3（ 3 ）：351-354, 2001. ure Ulcers, 24, WOCN Society, IL, 2003. （level V）（Japanese English abstract） 3 ）Ogawa N, Tanaka H, Toyoda M, et al：Improving CQ 12 Outcome management curative environment through mental relationship − CQ 12.1：Which measures should be undertaken in For a bedsore patient with spinal cord injury−．Jpn a hospital care setting to prevent pressure ulcers? J WOCN, 5（2）：26-30, 2002.（Level V）（Japanese ［Recommendation］ English abstract） 1. Choice of support surface based on the Braden 4）Garber SL, Rintala DH, Holmes SA, et al：A structured Scale is stronglyrecommended. educational model to improve pressure ulcer preven- ［Rating］A tion knowledge in veterans with spinal cord dysfunc- ［Recommendation］ tion. J Rehabil Res Dev, 39（ 5 ）：575-588, 2002. 2. Choice of support surface based on the OH Scale （Level II） maybe considered. 5）Phillips VL, Temkin A, Vesmarovich S, et al：Using ［Rating］C1 telehealth interventions to prevent pressure ulcers in ［Recommendation］ newlyinjured spinal cord injurypatients post- 3. Deployment of a multidisciplinary wound care discharge. Results from a pilot study. Int J Technol team maybe considered. Assess Health Care, 15（4）：749-755, 1999.（Level ［Rating］C1 III） ［Recommendation］ 6）Jacalyn A, Jane R：A prospective evaluation of a 4. Assignment of wound ostomyand continence pressure ulcer prevention and management E- nurse maybe considered. Learning program for adults with spinal cord injury. ［Rating］C1 OstomyWound Manage, 56（ 8 ） ：40-50, 2010. ［Recommendation］ （Level V） 5. Introduction of reimbursement system for 7 ）Wound Ostomyand Continence Nurses Society： pressure ulcer high risk patient care maybe Guideline for Prevention and Management of Press- considered. ure Ulcers, 24, WOCN Society, IL, 2003． ［Rating］C1

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［Recommendation］ preventing pressure ulcers. 6. Implementation of comprehensive programs and An historical controlled studyconducted bySobue protocols maybe considered. et al. examined the prevalence of pressure ulcers in ［Rating］C1 hospital before and after group training bya wound ［Recommendation］ ostomyand continence nurse 4）. The results of the ［ Analysis ］Comfort Ss meta-analysis1） of nine stu- studyindicated that the rate of pressure ulcer dies found after a search using the keywords, development was significantlylower（ p ＜ 0. 05 ） \ Braden Sand\ support surface, Sexamines the three years after, compared to six months before, choice of support surfaces based on risk assessment commencement of training. These data suggest that conducted with the Braden Scale at acute treatment employing a wound ostomy and continence nurse may facilities and universityhospitals. Comfort Ss study have a significantlypositive effect on the prevention found that the odds ratio of pressure ulcer develop- of pressure ulcers. ment in the group using support surfaces chosen on One prospective cohort studyinvolving 190 wound the basis of risk assessment using the Braden Scale ostomyand continence nurses（ 111 nurses who was 0.335（95% CI = 0.220〜0.508）. This report de- introduced the afore-mentioned reimbursement sys- monstrates a high level of efficacyin using Braden tem（see item 5 above）, and 79 who did not）found Scale risk assessment as a basis for choosing a support that the estimated incidence of pressure ulcer surface for pressure ulcer prevention, and is therefore development in reimbursement system-introduced stronglyrecommended. hospital was significantlylower than that in non- An historical controlled studybyTakagi et al. introduced hospitals（ p = 0. 008 ）5）. These results evaluated the criteria for selecting support surfaces indicate that the reimbursement system can produce based on the OH scale, using as the experimental a significant decrease in the incidence of pressure group, 445 patients, and as the control group, 354 ulcer development. patients, hospitalized in a general hospital with 198 A meta-analysis examining the effect of utilizing beds2）. The results of the studyindicated that the rate clinical paths on the formation of pressure ulcers in of pressure ulcer development in the experimental post-operative femoral neck fracture patients6）found group was significantlylower（p ＜ 0.05）, thus de- the odds ratio for pressure ulcer development to be monstrating the utilityof the algorithm based on the 0.48（95% CI = 0.30〜0.75）in 2935 subjects across OH Scale for choosing appropriate support surfaces six comparative studies. An historical controlled for pressure ulcer prevention. studybyde Laat et al. involving 399 adult patients in A longitudinal studybyGranick et al. examined the an intensive care unit of an universityhospital（28 efficacyof prophylactictreatment administered to 690 beds ）examined the efficacyof a care regimen for patients at an universityhospital byan interdisciplin- prevention of pressure ulcer based on the Dutch arywound care team 3）. The results of the study AHCPR/EPUAP guidelines7）. The three-month mark demonstrated that the prevalence of pressure ulcers was established as a baseline, and changes in patientsS declined steadilyfrom the first, through the second condition were monitored from months 3 to 6 and and third years of intervention（p ＜ 0.05）. A com- months 12 to15 after implementation of the protocol. parison of the number of new cases of pressure ulcers The results indicated a significant reduction in the in the first and third years shows a significant decline rate of pressure ulcer development（ p = 0. 04 ）.In （p ＜ 0.005）. In addition, several cohort studies have addition, there are a number of cohort studies which reported a decrease in the number of both existing have examined the efficacyof comprehensive press- pressure ulcer cases and new cases following in- ure ulcer prevention regimens. As can be seen, tervention bya multidisciplinarywound care team measures utilizing clinical paths, guidelines, and consisting of physicians, nurses, dietitians, occupation- comprehensive programs have proved to be effective al therapists, pharmacologists, registered dieticians, in preventing pressure ulcer development. However, and administrative staff at general and acute phase as the source of evidence is based onlyon the meta- treatment facilities. These data demonstrate the analysis of clinical paths in post-operative femoral efficacyof multidisciplinarywound care team in neck fracture patients and on some cohort studies, the

―G−75― ―87― methods reviewed here have been assigned a consultation with WOC nurses and similar compre- recommendation rating of C1. hensive care for pressure ulcers at two long-term care facilities（ facilityA, 150 beds; facilityB, 110 beds ） References have been examined in a longitudinal study1）. The 1 ）Comfort EH：Reducing pressure ulcer incidence results indicated that there was a significant decrease through Braden Scale risk assessment and support in the rate of pressure ulcer development four months surface use. Adv Skin Wound Care, 21（7）：330-334, after commencement of the program（ P = 0. 02 ）, 2008.（Level I） suggesting that the adoption of comprehensive 2）Takaki Y, Toyohara T：Use of criteria for the selec- programs and protocols at long-term care facilities is tion support surfaces and changes in the incidence of effective in preventing pressure ulcer development. pressure ulcer. Jpn J PU, 10（ 1 ）：39-43, 2008. An historical controlled studyof the efficacyof a （Level IV）（Japanese English abstract） Braden Scale-based pressure ulcer prevention algor- 3）Granick MS, McGowan E, Long CD：Outcome assess- ithm employed at a special elderly care facility（120 ment of an in-hospital cross-functional wound care beds）found a marked decrease in the prevalence of team. Plast Reconstr Surg, 101（5）：1243-1247, 1998. pressure ulcer nine months after the implementation （Level IV） of the algorithm as compared to nine months prior to 4）Sobue M, Tanahashi S, Hori S, et al：The effects of implementation（P ＜ 0.01）2）. This evidence suggests caring for pressure ulcers bythe skin care committee. that the use of algorithms based on the Braden Scale Jpn J PU, 7（1）：43-52, 2005.（Level IV）（Japanese at long-term care facilities is effective for pressure English abstract） ulcers prevention. 5）Sanada H, Mizokami Y, Minami Y, et al：The impact References of reimbursement system for pressure ulcer high risk patient care on the pressure ulcer incidence and 1 ）Lyder CH, Shannon R, Empleo-Frazier O, et al：A medical cost. Jpn J WOCN, 11（ 2 ）：59-62, 2007. comprehensive program to prevent pressure ulcers （Level IV）（Japanese English abstract） in long-term care：exploring costs and outcomes. 6 ）Neuman MD, Archan S, Karlawish JH, et al：The OstomyWound Manage, 48（ 4 ） ：52-62, 2002. relationship between short-term mortalityand qual- （Level IV） ityof care for hip fracture：a meta-analysisof clinical 2）Sanada H, Sugama J, Sugimura S, et al：The effec- pathways for hip fracture. J Am Geriatr Soc, 57 tiveness of care algorithm for prevention of pressure （11）：2046-2054, 2009.（Level I） ulcer in a long term care facility. Jpn J Nursing 7）de Laat EH, Pickkers P, Schoonhoven L, et al：Guide- Society, elderly 25, 170-173, 1994.（ Level IV ） line implementation results in a decrease of pressure （Japanese） ulcer incidence in criticallyill patients. Crit Care Med, 35（3）：815-820, 2007.（Level IV） 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 and team maybe considered. 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.

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［Rating］C1 References ［ Analysis ］A longitudinal study conducted by Ogawa et al. involving 48 patients with pressure 1 ）Ogawa R, Kikuchi M, Kato K, et al：Prevention ulcers at a general ward and a nursing ward effects and therapeutic outcomes of pressure ulcer examined the efficacyof a multidisciplinarywound based on a creation of committee. Jpn J PU, 7（2）： management team in pressure ulcer healing rate1）. 184-189, 2005.（ Level IV ）（ Japanese English ab- The studyreported a significant improvement in the stract） DESIGN scores six months after the start of the teamSs 2）Sanada H, Nakagami G, Mizokami Y, et al：Evaluat- activities as compared to scores obtained six months ing effect of new incentive system for high-risk prior to the commencement of their activities（p ＜ pressure ulcer patients on wound healing and cost- 0.05）, stronglyindicating the positive effect of such effectiveness：A cohort study. Int J Nurs Stud, 47 multidisciplinaryteams on wound healing. （3）：279-286, 2010.（Level IV） A prospective cohort studyexamined the impact of 3）Takaki Y, Shirayama C, Masutomi T, et al：Practice introducing reimbursement system for high risk report of a WOC-certified expert nurse Ss pressure patients on pressure ulcer healing at a total of 59 ulcer care in a long team care unit. Jpn J WOCN, 6 health care facilities, including advanced treatment （2）：20-24, 2003.（Level V）（Japanese English ab- facilities, regional central hospital, and general stract） hospitals2）. The studyreported that the DESIGN scores for patients in facilities that introduced CQ 12. 4：Which measures are recommended to reimbursement system had decreased during three promote healing of pressure ulcers in a long-term care weeks significantlymore compared to those patients facility? in facilities that had no billable services（p = 0.002）. ［Recommendation］ Further, multiple regression analysis using the 1. Deployment of a multidisciplinary wound care decrease in the DESIGN score as a dependent variable team is recommended. found a significant correlation between pressure ulcer ［Rating］B healing and the implementation of the afore- ［Recommendation］ mentioned care（p ＜ 0.001）. This data suggests that 2. Implementation of comprehensive programs and the introduction of reimbursement system for high protocols maybe considered. risk patient care has a positive impact on the healing ［Rating］C1 of pressure ulcer. ［Analysis］A randomized controlled trial involving Two case reports examined the impact of care 44 nursing homes（ intervention group, 21; control provided bywound ostomyand continence nurse at a group, 23）assessed the efficacyof a multifunctional nursing ward in a coloproctological facility3）.Inthe wound care team in promoting pressure ulcer healing first of these reports, improvement was seen in and found that the intervention group showed a patientsSpressure ulcers as a result of the selection of higher healing rate than the control group（P = 0.07） proper support surface bywound ostomyand with a hazard ratio of 1.73（P = 0.003）1）. This data continence nurse. The second studyfailed to assess indicate that the deployment of a multifunctional the effect of care administered bywound ostomyand wound care team at a long-term care facilityis likely continence nurse on cases of prolonged recovery to have a positive impact on the healing rates of caused bycontamination of the wounds byurine. In pressure ulcer. However, it should be noted that only the former, the deployment of wound ostomy and 80% of the enrolled patients suffered from pressure continence nurse as one of the conditions stipulated in ulcers, while 20% had leg ulcers. the introduction of reimbursement system for high A historical controlled studycompared healing time risk patient care can be seen as a major contributing of pressure ulcers among patients at a long-term care factor in the success of these services. Taken as a facility（ 77 beds ）who were either administered a whole, these data suggest that the care administered care protocol based on guidelines or treated according bywound ostomyand continence nurse has a positive to conventional methods2）. The subjects were divided impact on the healing of pressure ulcers. into three groups based on three time frames: before

―G−77― ―89― intervention, immediatelyafter intervention, and pain in home care pressure ulcer patients（ p = 0. three years after intervention. Using healing of 042）2）. Further, a descriptive and transversal study pressure ulcer in each group as the end-point, the conducted byBlanes et al. reported that among out- survival curve was assessed bythe Log rank test. The patients with traumatic spinal cord injuries, the results of this assessment found a significant differ- average mental health scores for those patients ence between each of the three groups in terms of the suffering from pressure ulcers were significantly duration required for pressure ulcer healing（ Log lower in comparison with those of who did not suffer rank = 9. 49, P ＜. 01 ）. These data suggest that the from pressure ulcers（p = 0.001）3）. Clearly, the fact adoption of comprehensive programs such as that the QOL of patients is influenced significantlyby guideline-based protocols at long-term care facilities the presence of pressure ulcers, makes a careful has a positive effect on promoting healing of pressure assessment of patientsSQOL imperative. ulcers. According to ten quantitative studies and 21 qualitative studies selected through systematic re- References view, there are 11 factors which are thought to 1）Vu T, Harris A, Duncan G, et al：Cost-effectiveness of influence the health-related QOL of pressure ulcer multidisciplinarywound care in nursing homes：a patients4）. These are: physical impact and limitation, pseudo-randomized pragmatic cluster trial. Fam impact of pressure ulcer symptoms, need versus Pract, 24（4）：372-379, 2007.（Level II） impact of interventions, impact on general health and 2）Xakellis GC, Frantz RA, Lewis A, et al：Translating consequences, psychological impact, perceived etiolo- pressure ulcer guidelines into practice：ItSs harder gy（ anger felt by patients who associated their than it sounds. Adv Skin Wound Care, 14（ 5 ）： development of pressure ulcers with perceived 249-256, 258, 2001.（Level IV） inadequacies in health care ）, need for knowledge, social impact, healthcare provider-patient relation- CQ 13 QOL/ Pain ships, impact on others, and financial impact. It should CQ 13. 1：How can the qualityof life（ QOL ）of be noted that although this article is a systematic pressure ulcer patients be assessed? review, its scope is restricted to a compilation of ［Recommendation］The QOL of the patients may quantitative and qualitative studies. For this reason, be assessed along physiological, psychological, and the studyhas been assigned the recommendation social parameters. rating of C1. ［Rating］C1 References ［ Analysis ］A longitudinal multivariate analysis was conducted on the basis of reports filed everysix 1）Degenholtz HB, Rosen J, Castle N, et al：The associa- months bynursing home residents in which the tion between changes in health status and nursing participants reported the relationship between home resident qualityof life. Gerontologist, 48（5）： changes in their QOL and the prevalence of their 584-592, 2008.（Level IV） pressure ulcers. The results of the studyindicated an 2）Franks PJ, Winterberg H, Moffatt CJ：Health-related inverse relationship between the prevalence of qualityof life and pressure ulceration assessment in pressure ulcers（Stage II or higher）and the sense of patients treated in the community. Wound Repair autonomy, security, and psychological well-being Regen, 10（3）：133-140, 2002.（Level V） reported bythe patients at six-month intervals 1）. 3）Blanes L, Carmagnani MI, Ferreira LM：Qualityof Another cross-sectional studyusing the SF-36 TM（a life and self-esteem of persons with paraplegia living widelyaccepted scale used to assess\Health Related in São Paulo, Brazil. Qual Life Res, 18（ 1 ）：15-21, Qualityof LifeS）to examine the physical functional- 2009.（Level V） ity（p ＜ 0.001）, social functionality（p ＜ 0.001）, self- 4）Gorecki C, Brown JM, Nelson EA, et al：Impact of care（p = 0.010）, and mobility（p = 0.001）of press- pressure ulcers on qualityof life in older patients: a ure ulcer patients confined to their home reported systematic review. J Am Geriatr Soc, 57（ 7 ）： significantlylower scores in these categories. A cross- 1175-1183, 2009.（Level I） sectional studyhas reported high scores for bodily

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CQ 13.2：For which stage of pressure ulcer is pain of the patients reported continuous pain. These data assessment recommended? indicate the need to assess pain levels in pressure ［Recommendation］Pain maybe assessed at any ulcer patients not onlywhen treatment is adminis- stage of pressure ulcer. tered but also when the patients are at rest. ［Rating］C1 References ［Analysis］A cross-sectional study of 32 patients recruited from acute care settings, extended care 1 ）Szor JK, Bourguignon C：Description of pressure settings, and home care settings with stage II, III, and ulcer pain at rest and at dressing change. J Wound IV pressure ulcers found that 75% reported mild pain, OstomyContinence Nurs, 26（ 3 ）：115-120, 1999. while 18% reported excruciating pain1）. Another （Level V） cross-sectional studybased on an interview of 44 patients in an acute care setting reported a correlation CQ 13.4：Which tools can be used to assess pressure- between the VAS（visual analog scale）and stage of ulcer-related pain? pressure ulcer（r = 0.37, P ＜ 0.01）, with a positive ［Recommendation］Pain maybe assessed using a correlation between the depth of the wound and the validated scale. intensityof pain 2）. However, pain has reportedly ［Rating］C1 accompanied even relativelyshallow wounds 1）.Accor- ［Analysis］A cross-sectional study based on inter- dingly,pain assessment is necessaryat everystage of views of 44 patients with Stage I~IV pressure ulcers pressure ulcer for the accurate assessment of interned in an acute care facilityfound that the degree patientsSQOL. of pain reported bythe patients in the interviews correlated with the VAS（visual analog scale; r = 0.59, References P ＜ 0.1）as well as with the FRS（faces pain rating 1）Szor JK, Bourguignon C: Description of pressure ulcer Ssle; r = 0.53, P ＜ 0.1）1）. pain at rest and at dressing change. J Wound Ostomy Another cross-sectional studyof 47 patients with Continence Nurs, 26（3）：115-120, 1999.（Level V） Stage II~IV pressure ulcers found that 94. 6% of 2）Dallam L, Smyth C, Jackson BS, et al: Pressure ulcer patients who reported pressure-ulcer-related pain pain: assessment and quantification. J Wound Ostomy showed a correlation between their FRS and MPQ Continence Nurs, 22（5）：211-218, 1995.（Level V） （McGill pain questionnaire）scores（r = 0.90, P ＜ 0. 001）2）. These data indicate that the VAS, FRS, and CQ 13. 3：When should pain assessment be con- MPQ subjective rating systems are able accurately to ducted? measure the degree of pain felt bypressure ulcer ［Recommendation］Pain assessment maybe con- patients and are therefore appropriate tools for the ducted at anytime（ regardless of whether topical assessment of pressure-ulcer-related pain. intervention is being administered）. References ［Rating］C1 ［ Analysis ］According to a cross-sectional study 1）Dallam L, Smyth C, Jackson BS, et al：Pressure ulcer conducted on 32 patients with stage II, III, or IV pain: assessment and quantification. J Wound Ostomy pressure ulcers interned at acute care, extended care, Continence Nurs, 22（5）：211-218, 1995.（Level V） and home care settings using the MPQ（McGill pain 2 ）Günes UY：A descriptive studyof pressure ulcer questionnaire ）, 87. 5% reported feeling pain when pain. OstomyWound Manage, 54（2）：56-61, 2008. their dressings were changed, and 84. 4% reported （Level V） similar sensations when at rest1）. Furthermore, 42%

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