Study Design and Patient Selection
skin defects
CROSS, SCAR
This study was a prospective, open-label intrapatient randomized controlled trial performed at the Red Cross Hospital in Beverwijk, the Netherlands. The objectives of this study were to evaluate the short- and long-term first-in-man safety (phase I) and efficacy (phase II) of an acellular dermal substitute and compare the outcomes with the standard of care, which was 1:1.5 ratio meshed STSG in full-thickness skin defects. The authors used an intrapatient comparison model because wound-healing characteristics and scar formation are generally highly patient specific. Two comparable wound areas were chosen, one wound area was covered with dermal matrix on top of which a 1:1.5 ratio meshed STSG was placed, and the other wound area was covered with the conventional 1:1.5 ratio meshed STSG only. The allocation of treatment was randomized.The trials were performed in accordance with the Declaration of Helsinki, Guidelines for Good Clinical Practice, and the CONSORT (Consolidated Standards of Reporting Trials) statement for reporting within-person randomized trials.Patients with acute full-thickness burn wounds that required skin grafting or scars requiring reconstructive surgery who were seen between June 2013 and April 2014 were included in the phase I trial, and those seen between March 2015 and August 2016 were included in the phase II trial. Because the phase I trial analysis confirmed that the dermal substitute combined with meshed STSG is a safe wound treatment modality, the authors continued with the phase II efficacy trial. For the purpose of maximum power, the data from the phase I and II studies were pooled, and the pooled results are presented. The CONSORT flow diagram is shown in Figure 
CONSORT FLOW DIAGRAM OF THE PHASE I AND PHASE II TRIALS (COMBINED)
Abbreviation: STSG, split-thickness skin graft.All admitted patients were checked for eligibility according to the inclusion and exclusion criteria (Table INCLUSION AND EXCLUSION CRITERIAIn all three trials, all participants provided written informed consent before participation.