A multicentre, intra-patient randomised controlled Phase III study to confirm the efficacy and safety of denovoSkin™, a bilayer engineered collagen-based skin graft composed of autologous fibroblasts and keratinocytes, for the treatment of patients with deep partial and full-thickness burns

Deep partial and full-thickness burns

A composite endpoint whereby success is defined by meeting both of the following criteria: • Wound closure defined as at least 95% epithelialisation at 10 weeks post-grafting • POSAS v2.0 overall opinion of at most 5, based on the observer evaluation (observer part of POSAS) at 6 months post-grafting

First Secondary Endpoints: • Ratio of covered surface area to biopsy site/donor site surface area at 4 weeks post-grafting • Limitation of scar contracture by assessing the size of the grafted areas at 6 months as compared to the grafting visit, Other Secondary Endpoints: • Epithelialisation percentage at 3 months and 6 months post-grafting • Graft take at 14 and 21 days post-grafting • Assessment of the donor sites (i.e., biopsies for IMP manufacturing and STSG grafting) at 4 and 10 weeks and 3, 6, 12, and 24 months post-grafting for: • Infection • Scar quality (patient and observer assessment using the POSAS v2.0 questionnaire), Other Secondary Endpoints: Assessment of the grafted burn wounds areas (i.e., experimental and control areas) at 4 and 10 weeks and 3, 6, 12, and 24 months post-grafting for: • Infection • Scar quality (patient and observer assessment using the POSAS v2.0 questionnaire). Note: Observer assessment using POSAS at 6 months is part of the composite primary endpoint., Other Secondary Endpoints: Limitation of scar contracture by assessing the size of the grafted areas at 12 and 24 months post-grafting

No related papers found yet.

Belgium, France, Germany, Italy, Netherlands, Poland, Portugal, Spain