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Evaluation of Apligraf ® persistence and basement membrane restoration in donor site wounds: a pilot study
Author(s) -
Hu Shasa,
Kirsner Robert S.,
Falanga Vincent,
Phillips Tania,
Eaglstein William H.
Publication year - 2006
Publication title -
wound repair and regeneration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.847
H-Index - 109
eISSN - 1524-475X
pISSN - 1067-1927
DOI - 10.1111/j.1743-6109.2006.00148.x
Subject(s) - dermis , basement membrane , medicine , wound healing , surgery , pathology
Apligraf ® is a bilayered tissue‐engineered product consisting of a bovine collagen matrix with neonatal fibroblasts, overlaid by a stratified epithelium containing living keratinocytes. The United States Food and Drug Administration has approved its use for venous leg ulcers and neuropathic diabetic foot ulcers. Apligraf ® provides a dermal matrix and produces cytokines similar to the human skin. However, its mechanism of action and ultimate fate in host wounds are unclear. The aim of this study was to evaluate the persistence of Apligraf ® fibroblasts and keratinocytes in human acute partial‐thickness wounds (split‐thickness donor sites) treated with Apligraf ® . In an open‐label, within‐patient, three‐centered, controlled pilot study, 10 patients were treated with Apligraf ® , Apligraf ® dermis only (without epidermis), and a polyurethane film for donor site wounds of the same size, depth, and anatomical location. Apligraf ® DNA persistence was the primary outcome measure. Basement membrane components, cosmetic outcome, time to wound healing, and safety parameters were secondary outcome measures. One week after the initial treatment, reverse transcription polymerase chain reaction analysis found that two Apligraf ® and two Apligraf ® dermis‐only‐treated sites had Apligraf ® DNA present. Four weeks posttreatment, only one Apligraf ® and one Apligraf ® dermis‐only sites showed the presence of Apligraf ® DNA. There was no difference between the three treatment modalities in establishing basement membrane in donor site wounds. No differences in other secondary outcomes were found. Apligraf ® DNA persisted in a minority of patients at 4 weeks in acute partial‐thickness wounds. Apligraf ® 's success in speeding healing of acute wounds appears to be related to factors other than the persistence of donor DNA or effect on basement membrane restoration.