Sanders L, Landsman AS, Landsman A, Keller N, Cook J, Cook E, Hopson M, et al.
Ostomy/wound management. Date of publication 2014 Sep 1;volume 60(9):26-38.
1. Ostomy Wound Manage. 2014 Sep;60(9):26-38.
A prospective, multicenter, randomized, controlled clinical trial comparing a
bioengineered skin substitute to a human skin allograft.
Sanders L(1), Landsman AS(2), Landsman A(3), Keller N(4), Cook J(5), Cook E(5),
Hopson M(6).
Author information:
(1)Department of Podiatric Medicine, Temple University, School of Podiatric
Medicine, Philadelphia, PA.
(2)Harvard Medical School, Cambridge, MA; and Cambridge Health Alliance,
Cambridge, MA; email:alandsman@cha.harvard.edu.
(3)Soluble Systems, Newport News, VA.
(4)Colonial Foot Care, Hampton, VA.
(5)Harvard Medical School, Cambridge, MA.
(6)TPMG Orthopedics and Sports Medicine, Williamsburg, VA.
An estimated 25% of all people with diabetes may experience a foot ulcer in their
lifetime, which may lead to serious complications including infection and
amputation. A prospective, multicenter, randomized, controlled clinical trial was
conducted to compare an in vitro-engineered, human fibroblast-derived dermal skin
(HFDS) substitute and a biologically active cryopreserved human skin allograft
(HSA) to determine the relative number of diabetic foot ulcers (DFUs) healed
(100% epithelialization without any drainage) and the number of grafts required
by week 12. Secondary variables included the proportion of healed patients at
weeks 16 and 20, time to healing during the study, and wound size progression.
The 23 eligible participants (11 randomized to the HSA, 12 to the HFDS group)
were recruited from two hospital-based outpatient wound care centers. Baseline
patient (body mass index, age, gender, race, type and duration of diabetes,
presence of neuropathy and/or peripheral arterial disease, tobacco use) and wound
characteristics (size and duration) were recorded, and follow-up visits occurred
every week for up to 20 weeks. Descriptive and multivariate regression analyses
were used to compare wound outcomes. At baseline, no statistically significant
differences between patients and wounds were observed. At week 12, seven (63.6%)
patients in the HSA and four (33.3%) in the HFDS group were healed (P = 0.0498).
At the end of the 20-week evaluation period, 90.91% of HSA versus 66.67% of HFDS
were healed (P = 0.4282). Among the subset of wounds that healed during the first
12 weeks of treatment, an average of 4.36 (range 2-7) HSA grafts were applied
versus 8.92 (range 6-12) in the HFDS subset (P <0.0001, SE 0.77584). Time to
healing in the HSA group was significantly shorter (8.9 weeks) than in the HFDS
group (12.5 weeks) (log-rank test, P = 0.0323). The results of this study are
similar to previous outcomes reported using these treatment modalities and
suggest that, after 12 weeks of care, DFUs managed with HSA are approximately
twice as likely to heal as DFUs managed with HFDS with approximately half the
number of grafts required. Research confirming these results with a larger sample
size and inpatients with different types of wounds is warranted.
PMID: 25211605 [Indexed for MEDLINE]
