Study end points for efficacy Clause Samples

Study end points for efficacy. The primary end point for device efficacy is a statistically significant increase in the donor skin area of the closed wound at post operative day (POD) 28 divided by the area of the donor skin used to close that area (section 6.4. 1). Secondary end points for efficacy include: a) Percentage engraftment (i.e., closed wound) at POD 14 (section 6.3.2); b) Percentage TBSA closed at POD 28; and c) scoring of scar qualities of erythema, pigmentation, pliability and scar height by the Vancouver Scar Scale.