Study Procedure
STERILE, ADHESION
The wound bed was prepared according to routine procedures (eg, tangential excision [Humby knife] and/or hydrojet techniques [Versajet; Smith & Nephew]) for acute wounds and sharp excision for reconstructive wounds. The STSG was harvested using an electric Zimmer dermatome (Zimmer Inc) and expanded to a 1:1.5 ratio by mesh technique. The dermal matrix was placed onto the wound bed and hydrated with sterile 0.9% sodium chloride solution. The surgeon applied the dermal matrix and trimmed the material to align with the wound edges. Air inclusions between the wound bed and the product were removed because they could impair diffusion of nutrients and cell migration and prevent proper adhesion. The surgeon fixed the STSG on both the dermal matrix and the control treatment area using staples. Postoperative wound management was identical for both wound areas using a nonadherent membranous dressing. Follow-up moments in the phase I and phase II trials were at 5 to 7 days, 21 days, 3 months, and 12 months after surgery. In the long-term follow-up study, the mean time postsurgery was 71 (range, 49–86) months.