The efficacy and durability of wound closure was examined in a prospective randomized unbalanced clinical trial using the application of a living serum-free cultured epidermal autograft in conjunction with wound-area debridement and a four-layer compression wrap (N=10) compared with wound-area debridement and a four-layer compression wrap in patients with hard-to-heal leg ulcers arising from confirmed venous stasis (N=5). All 15 patients who presented with full-thickness venous ulceration were treated weekly for 8 weeks, with a 12-week final evaluation. The average time to wound closure for the grafted wounds was 4.1 weeks for 80% (8/10) of the cases that closed in 12 weeks compared with 12 weeks for the one closed in the control case. All of the grafted wounds remained closed at 12-month follow-up and one more healed at 30 weeks postenrollment. In the control group, one additional wound healed at 21 weeks postenrollment after the placement of an autograft. No serious adverse events were reported and subjective pain assessment was substantially reduced immediately after graft application. The graft treatment significantly improved outcome and provided durable wound closure. The data suggest that this adaption of this procedure may reduce the management costs of these wound types.
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