Can a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization?

A bilayered tissue-engineered skin graft composed of human neonatal foreskin fibroblasts and keratinocytes in a type I bovine collagen matrix has been developed. We sought to determine if this graft improves wound healing after lower extremity revascularization. Thirty-one previously ischemic foot wounds were randomly assigned to moist dressing changes or tissue-engineered skin graft within 60 days of revascularization. In the grafted group, 10 received meshed and 11 received unmeshed graft. Wound healing was followed by wound area measurements and photography. There were no statistically significant differences between groups in patient age, sex, diabetes or renal failure risk factors, revascularization procedure, or wound location or size. Treatment with tissue-engineered skin graft was significantly more effective than moist dressing in the percentage of wounds healed (62 vs. 0% at 8 weeks, 86 vs. 40% at 12 weeks, p < 0.01) and the median time to complete wound closure (7 vs. 15 weeks, p = 0.0021, rank-sum test). There was no difference in the wound closure rate of meshed and unmeshed graft at 4, 8, 12, or 24 weeks (p > 0.05). Three indolent localized wound infections in the tissue-engineered skin graft group were the only complication. Tissue-engineered skin grafting can be used safely in previously ischemic wounds after lower extremity revascularization. Treatment with this graft promotes healing more rapidly and in more patients than standard moist dressings. It obviates the risk, inconvenience, and expense of donor skin harvesting, anesthesia, and hospitalization associated with autologous skin grafting. This graft may represent an advance in the treatment of previously ischemic lower extremity foot wounds.

RCT Entities:   Population Interventions Outcomes