Graft take, wound healing, and serious adverse events (SAEs)
EPITHELIALIZATION
The primary outcome in the phase I trial was graft take of the dermal matrix versus the control area at 5 to 7 days postsurgery. Assessment of wound epithelialization after the initial phase of graft take was used as a marker for undisturbed wound healing. Other wound-healing parameters included percent (%) epithelialization at 21 to 23 days after surgery and time required (in days) to reach complete wound closure. Experienced clinicians monitored and assessed graft take and wound-healing parameters. For the duration of the phase I and phase II trials, the occurrence of SAEs was also monitored.