Trials / Active Not Recruiting
Active Not RecruitingNCT03394612
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children
A Phase II, Prospective, Intra-patient Randomised Controlled, Multicentre Study to Evaluate the Safety and Efficacy of an Autologous Bio-engineered Dermo-epidermal Skin Substitute (EHSG-KF) for the Treatment of Full-Thickness Defects in Adults and Children in Comparison to Autologous Split-thickness Skin Grafts (STSG)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- CUTISS AG · Industry
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Not accepted
Summary
This phase II trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and children with full-thickness Skin defects.
Detailed description
This multicentre phase II clinical trial will target adults and children with fullt-thickness skin defects to elucidate the benefit of a tissue-engineered autologous skin substitute. Particular emphasis, apart from safety, will be placed on efficacy, e.g. scar quality, in comparison to meshed STSG.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | EHSG-KF | Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area |
| BIOLOGICAL | STSG | Transplantation of autologous split-thickness skin graft to the control area |
Timeline
- Start date
- 2018-02-14
- Primary completion
- 2023-12-01
- Completion
- 2026-12-01
- First posted
- 2018-01-09
- Last updated
- 2025-02-24
Locations
7 sites across 3 countries: Italy, Netherlands, Switzerland
Source: ClinicalTrials.gov record NCT03394612. Inclusion in this directory is not an endorsement.