DiDomenico L, Landsman AR, Emch KJ, Landsman A, et al.
Wounds : a compendium of clinical research and practice. Date of publication 2011 Jul 1;volume 23(7):184-9.
1. Wounds. 2011 Jul;23(7):184-9.
A prospective comparison of diabetic foot ulcers treated with
either a cryopreserved skin allograft or a bioengineered skin substitute.
DiDomenico L(1), Landsman AR(2), Emch KJ(3), Landsman A(4).
Author information:
(1)Ankle and Foot Centers, Boardman, Ohio.
(2)Consultant to Soluble Systems, Newport News, Virginia.
(3)Ankle and Foot Centers, Boardman, Ohio.
(4)2Consultant to Soluble Systems, Newport News, Virginia; 3Division of Podiatric
Surgery, Cambridge Health Alliance, Cambridge, Massachusetts and Harvard Medical
School, Boston, Massachusetts; Email:alandsman@cha.harvard.edu.
Background. It was hypothesized that the rate of wound closure and the number of
grafts required will be the same when treating diabetic foot ulcers with
TheraSkin®, a cryopreserved split-thickness skin allograft (SSA), as compared to
Apligraft®, a bioengineered skin substitute (BSS).METHODS: A prospective study
using sequentially enrolled patients seen in a large podiatric practice
encompassing multiple locations was conducted. Patients were sequentially
enrolled and treated with either BSS or SSA. All other factors of treatment were
standardized across the patient population. Data analysis included an analysis of
co-factors in each group in order to determine if anything else may have
influenced the outcomes.
RESULTS: Data from 17 wounds (16 patients) treated with BSS and 12 wounds treated
with SSA were analyzed. The average wound sizes were comparable, as was the
average number of applications utilized. These data revealed that 41.3% of the
wounds treated with BSS closed within 12 weeks, as compared to 66.7% of the
wounds treated with SSA. At 20 weeks, 47.1% of the wounds in the BSS group
closed, while 66.7% of the SSA wounds closed. There were a comparable number of
adverse events in each group, with none that were a direct result of the biologic
material being used.
CONCLUSION: SSA resulted in a higher percentage of wounds closing after 12 and 20
weeks, as compared to wounds treated with BSS. There were no adverse events noted
that were directly related to either graft material.
PMID: 25879172
