Human Skin Allograft for Patients With Diabetic Foot Ulcers, Venous Leg Ulcers, or Surgical/Traumatic Wounds Retrospective, Descriptive Study.

Chronic wounds such as diabetic foot ulcers (DFU) and venous leg ulcers (VLU) may take a long time to heal and increase the risk of complications. Previous studies have suggested human skin allograft may facilitate healing of these chronic wounds. A retrospective, descriptive study was conducted among outpatients with nonhealing DFU, VLU, surgical, or traumatic wounds managed with a meshed, partial-thickness, cryopreserved human skin allograft. Charts of all patients who received an allograft from 2011 to 2013 were abstracted if the wound was >1 cm2, had a duration>30 days, was adequately debrided, and was free of infection before the first allograft application. Primary outcome was percentage of wounds healed (ie, 100% epithelialized) at 12 and 20 weeks. Secondary outcome was the number of recorded adverse events. Wound measurements (area--calculated as width x length in cm2), wound type and duration, number of allograft applications, number of adverse events, and race, smoking status, and body mass index were abstracted. Of the 49 patients (average age 64.3 [SD 15.0]; 64% male) who met the inclusion criteria, 13 did not have medical follow-up through the primary outcomes at 12 and 20 weeks, leaving 36 patients (average age 65.1 [SD 15.4]; 67% male) available for analysis. The most common diagnoses were VLU (18 patients, 50%) and traumatic wounds (9 patients, 25%). Average wound size was 19.4 cm2 (SD 29.3, range 1.2-156, median 9.5), and average wound duration at initial treatment was 17.2 (SD 17.0, range 4-72, excluding outlier) weeks. Seventeen (17) wounds (47%) healed by 12 weeks, and 21 (58%) were healed by week 20 with an average of 3.3 (SD 2.0) allograft applications. No serious adverse events occurred. The results of this study are encouraging and add to the currently available literature on the use of allograft skin for chronic wounds, but the study design and sample size limit the ability to interpret the observations. Prospective, controlled clinical studies are needed to compare the efficacy, effectiveness, and cost-effectiveness of human skin allograft to standard care and to other advanced care modalities.