Most venous ulcers respond well to compression therapy. However, a minority of wounds fail to heal with compression therapy alone. One of the options available to the healthcare provider is to treat the wound with a skin graft. Grafts can include full-thickness, partial-thickness, allogeneic (cultured), and artificial skin grafts.
The use of skin grafts for the treatment of venous ulcers is the subject of a Cochrane collaborative review.11 Two trials evaluated split-thickness autografts, three trials evaluated cultured keratinocyte allografts, one compared artificial skin with a dressing, and one compared artificial skin with a split-thickness skin graft.
The two small studies evaluating split-thickness autografts were pooled by the Cochrane group, but the results did not show a significant benefit of skin grafting.11 Both studies were small, and used different placebo treatments.
Graftskin (Apligraf) is a bilayered skin equivalent that includes both dermal and epidermal components.12 It is manufactured by harvesting neonatal foreskins and extracting both keratinocytes and fibroblasts, which are then separately cultured to create the epidermal and dermal components, respectively. Graftskin has been studied for the treatment of venous leg ulcers.13,14 In a study that enrolled 240 patients, the percentage of ulcers healed after 24 weeks was significantly higher in those treated with Graftskin plus standard care (compression) than in those treated with compression alone (57% versus 40%).15 Notably, secondary analyses evaluating the relative efficacy of Graftskin in wounds of more than one year's duration demonstrated that the benefit of Graftskin was most significant for patients with older wounds (47% versus 19%). Among patients with wounds of less than one year's duration, there was no statistically significant difference in the percentage healed after 24 weeks between those treated with Graftskin and those treated with placebo (66% versus 73%). The Cochrane group analysed this trial data and concluded that the relative risk of healing with artificial skin versus standard dressings is 1-29 (CI 1-04-1-60).
Three studies compared cultured keratinocyte allografts with standard dressings. A pooled analysis of these trials conducted by the Cochrane group did not demonstrate a significant benefit of allografts over control dressings, and the relative risk of healing with the keratinocyte allografts was 1-42 (CI 0-71-2-84). These were all small trials and may have been underpowered to demonstrate an effect.
A single study compared tissue-engineered skin with a split-thickness allograft, but failed to show any significant benefit of either treatment.16 Note, however, that this study was small and was conducted before the newest tissue-engineered skin became available.
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