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Contact Sensitivity in Patients with Leg Ulcerations: a North American Study

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Contact Sensitivity in Patients with Leg Ulcerations: a North American Study STUDY Contact Sensitivity in Patients With Leg Ulcerations A North American Study Liliana Saap, MD; Simone Fahim, MD; Emily Arsenault, MD; Melanie Pratt, MD; Tad Pierscianowski, MD; Vincent Falanga, MD; Anita Pedvis-Leftick, MD Objectives: (1) To determine the prevalence of aller- had no positive patch test result. The most common al- gen sensitivity in patients with past or present leg ulcers lergens were Myroxylon pereirae (balsam of Peru) (30% in 2 North American study centers vs European study [16/54]), bacitracin (24% [13/54]), fragrance mix (20% findings and the North American Contact Dermatitis [11/54]), wood tar mix (20% [11/54]), propylene glycol Group (NACDG) database and (2) to delineate a stan- (14% [7/52]), neomycin sulfate (13% [7/54]), benzal- dard battery of allergens for patch testing in North Ameri- konium chloride (13% [7/54]), carba mix (11% [6/54]), can patients that is representative of the newer dress- nickel sulfate (11% [6/54]), and control gel hydrocol- ings and wound care products. loid (11% [6/54]). Design: Fifty-four patients, with or without dermatitis, Conclusions: Comparable to European study findings, were prospectively entered in the study. The patients were there is a high incidence of positive patch test results in patch tested to the NACDG standard series and a com- patients with past or present leg ulcerations. The inci- prehensive supplemental series of 52 allergens. dences of the most common allergens in our patient popu- lation were higher than those seen in the NACDG, ex- Setting: Wound healing clinics at Boston University Roger cept for nickel. Using a modified leg ulcer series along Williams Medical Center and University of Ottawa. with the standard NACDG series is important in evalu- ating patients with leg ulcers. Results: Sixty-three percent (n=34) of patients had 1 or multiple positive patch test results, and 37% (n=20) Arch Dermatol. 2004;140:1241-1246 URING THE PAST 2 DE- It is suspected that the high inci- cades, European studies dence of sensitization in the leg ulcer pa- have investigated con- tient population is due to (1) the intrin- tact sensitivity in pa- sic allergenic properties of different tients with chronic leg ul- ointments and wound products used to Dcerations. The frequency of positive patch heal the ulcer, (2) the excessive duration test results found in this patient popula- of use of these products, and (3) the dis- tion has ranged from 40% to 82.5%, and rupted skin barrier (increased permeabil- sensitivities have involved 1 or multiple ity and inflammation) to which these prod- allergens.1-10 One study4 found a direct re- ucts are applied.11 These conditions can lationship between the duration of leg ul- From the Department of Dermatology and Skin Surgery, cers and the number of multiple positive CME course available at Boston University Roger allergen sensitivities. These authors’ find- www.archdermatol.com Williams Medical Center, ings suggest that an ulcer of long dura- Providence, RI (Drs Saap, tion has greater opportunity for contact lead to contact dermatitis of the leg, ulti- Arsenault, Falanga, and with different allergens and leads to in- mately impairing healing and prolonging Pedvis-Leftick); Department of creased sensitivity to these allergens. morbidity associated with leg ulcer- Dermatology, University of Patients with leg ulcers frequently be- ations. Recurrence of leg ulcers may be due Ottawa, Ottawa, Ontario come sensitized to topical allergens. Ex- to persistent or recurrent dermatitis. (Drs Fahim, Pratt, and amples of these allergens include neomy- Although several groups have stud- Pierscianowski); and cin sulfate, lanolin alcohols, Myroxylon ied contact sensitization in leg ulcer pa- Departments of Dermatology and Biochemistry, Boston pereirae (balsam of Peru), Amerchol L101, tients in Europe, the incidence of sensiti- University, Boston, Mass colophony, fragrance mix, propylene gly- zation has not been studied in North (Dr Falanga). The authors have col, paraben mix, budesonide, tixocortol- America, to our knowledge. In addition, no relevant financial interest in 21-pivalate, thiuram mix, and nickel sul- many new wound care products have not this article. fate, among others.1-10 been recently tested for contact sensitiza- (REPRINTED) ARCH DERMATOL / VOL 140, OCT 2004 WWW.ARCHDERMATOL.COM 1241 ©2004 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/29/2021 METHODS Table 1. Leg Ulcer Series Developed at Our Study Centers* We prospectively recruited 54 patients (19 men and 35 wom- 10% Pet abietic acid 20% Pet gentamicin sulfate en; mean±SD age, 65.24±13.96 years) with past or present leg Alginate dressings Hydrocolloids ulcerations, regardless of etiology or presence or absence of der- Calcium alginate dressing Control gel hydrocolloid matitis. Twenty-two patients were recruited at the Advanced 2% Pet aluminum chloride Thin polyurethane Wound Healing Center of Boston University Roger Williams hexahydrate Medical Center, and 32 patients were recruited at the Wound 50% Pet amerchol L101 Hydrogels 0.25% Aqs ammonium Hydroactive gel Care Center of Ottawa Civic Hospital, Ottawa. Patients were tetrachloroplatinate excluded from participation in the study if they were receiv- (platinum) ing an oral prednisone dosage of 20 mg/d or higher, or if they Hydrogel with propylene glycol were receiving any oral immunosuppressive therapy (ie, cy- Antimicrobial barrier–silver Collagen hydrogel closporine, azathioprine, methotrexate, mycophenolate mofetil, release dressing or cyclophosphamide). Informed consent was obtained from 5% Pet butylated Hydrofibers all patients in accord with each study center’s human research hydroxyanisole (BHA) committee, and the study protocols conformed to the ethical 20%* Pet cetyl stearyl alcohol Hyaluronic acid ester guidelines of the 1975 Declaration of Helsinki. 0.2% Pet chloroacetamide Sodium carboxymethyl cellulose A comprehensive questionnaire was filled out by all the 0.5% Aqs chlorhexidine 1.5% Hydrogen peroxide cream patients and included a detailed history of ulcer duration, heal- digluconate ing times, frequencies of ulcer recurrence, past and present ul- 1% Pet 4-chloro-3-cresol 3% Aqs hydrogen peroxide cer treatment, any associated dermatitis, and allergic reac- (PCMC) 1% Aqs clotrimazole 0.1% Pet iodopropynyl tions. A physical examination was performed at the initial butylcarbamate evaluation and consisted of the following: general appearance, 5% Pet clioquinol evaluation of skin disease and presence and severity of any der- Composite Mupirocin cream matitis, description of lower extremity ulcerations, and evalu- Nonadherent perforated Mupirocin ointment ation of the vascular state, including dorsalis pedis pulses, ankle- absorbent dressing brachial index by Doppler testing (if the patient did not have Compression bandages Specialty absorptives diabetes mellitus), and results of Doppler testing of the arter- Paste bandage Cadexomer iodine gel ies and veins, if previously performed. Layer 1 (soft cotton 2% Pet sorbic acid Patch tests consisting of 110 allergens affixed to 8-mm- padding) diameter Finn Chambers were applied and taped in a standard- Layer 2 (orthopedic wool) 5% Pet sulfanilamide ized order to hairless skin on the backs of the patients. The patch Layer 3 (light elastic Topical steroids pet test allergens consisted of the 2001 standard series from the compression) NACDG (Dr Pratt, written communication, July 10, 2001) and Layer 4 (self-adherent 0.5% Amcinonide† a leg ulcer series designed at our study centers consisting of 52 compression bandage) Table 1 0.25% Pet dodecyl gallate 1% Betamethasone-17-valerate allergens ( ). The leg ulcer series included a battery of Debriding agents 1% Clobetasol-17-propionate cosmetic allergens, topical medicaments, and wound care prod- Papain-urea ointment 1% Dexamethesone-21- ucts typically used in patients with leg ulcers at our 2 study cen- phosphate ters and other North American wound healing centers. This leg Collagenase ointment 1% Triamcinolone acetonide ulcer series incorporated representative samples of the major types Foams Transparent film dressing of dressings and products used in wound healing, such as trans- Polyurethane foam 2% Pet triclosan parent films, foams, hydrogels, hydrocolloids, alginates, hydro- Silicone foam 2% Pet triethanolamine fibers, and composite dressings, as well as topical antibiotics, an- 1% Framycetin sulfate 12% Pet wood tar mix (pine, birch, tiseptics, debriding agents, and topical corticosteroids. juniper, beech) Patch test results were read 48 hours and 96 or 120 hours 2% Pet fuscidic acid 20% Pet zinc oxide after application and were interpreted following the NACDG pro- tocol.12 Reactions that were evaluated as 1+ to 3+ (1+, weak posi- Abbreviations: Aqs, aqueous; PCMC, p-chloro-m-cresol; Pet, petrolatum. tive; 2+, strong positive; and 3+, extremely strong positive) were *Tested by Ottawa group separately as cetyl alcohol and stearyl alcohol. included in the results, while equivocal reactions were ex- †Tested by Ottawa group only. cluded. Clinical relevance was determined for each positive re- sult based on previously published criteria.12 Spearman rank cor- relation coefficient was used to determine any association between ulcer duration and number of positive allergen sensitivities. tion. This is particularly important considering that wound care clinics in North America may have different sensiti- zation patterns compared with those in Europe because RESULTS of differences
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