Phase III Study with an Autologous Dermo-epidermal Skin Substitute for the Treatment of Bu
This multicentre phase III clinical trial will target adults and adolescents of 12 years and older with severe burns to confirm the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in patients with deep partial and full-thickness burns as compared to split-thickness skin.
| Condition(s) | Burns |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This multicentre phase III clinical trial will target adults and adolescents of 12 years and older with severe burns to confirm the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in patients with deep partial and full-thickness burns as compared to split-thickness skin. |
| Who can participate | Inclusion Criteria: * Patients with deep partial or full-thickness thermal burns of ≥20% total body surface area (TBSA) for which excision and standard of care (SOC) (STSG) are clinically indicated * Patients of either sex aged ≥12 years * Signed informed consent from the patient and/or legally authorised representative Exclusion Criteria: * Burn wound areas solely located on the head and neck (i.e., test and control areas must NOT be located on head/neck) * Patients eligible to have all areas autografted in a single surgery or significantly earlier than the end of the manufacturing period of denovoSkin™, for whom the application of denovoSkin™ would delay the standard of care therapies * Patients with serologic evidence of active hepatitis B virus (HBV) infection (i.e., positive for Hepat |
| Ages | 12 Years |
| Sex | All |
| Lead sponsor | CUTISS AG |
| Locations | Beverwijk, Netherlands |
| Start date | 2024-12-13 |
| NCT ID | NCT06745557 |
| Official listing | https://clinicaltrials.gov/study/NCT06745557 |