drugset / Trial / NCT03394612
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children
Phase 2
Active not recruiting
20 enrolled
CUTISS AG
Julius Clinical · collabSintesi Research Srl · collabUniversity Hospital, Zürich · collabUniversity of Zurich · collabWyss Zurich · collab
RandomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-02-14
- Primary completion
- 2023-12-01
- Completion
- 2026-12
Publications
- Kemme FM, Pijpe A, Stoop MM, van Zuijlen PPM, Meuli M, Schiestl C, Hartmann-Fritsch F, Kim BS, Neuhaus K, Plock JA, Rittirsch D, Mujynya K, Reichmann E, Bottcher-Haberzeth S, Farkas M, Bressan J, Zamparelli M, Mataro I, Petroccione C, Pontini A, Azzena B, Marino D, Middelkoop E. Safety and efficacy of bio-engineered, autologous dermo-epidermal skin grafts in reconstructive surgery: 1-year results of a prospective, randomized, intra-patient controlled, multicenter phase II clinical trial. J Tissue Eng. 2026 Mar 23;17:20417314261429663. doi: 10.1177/20417314261429663. eCollection 2026 Jan-Dec.
- Schiestl C, Neuhaus K, Meuli M, Farkas M, Hartmann-Fritsch F, Elrod J, Bressan J, Reichmann E, Bottcher-Haberzeth S. Long-Term Outcomes of a Cultured Autologous Dermo-Epidermal Skin Substitute in Children: 5-Year Results of a Phase I Clinical Trial. J Burn Care Res. 2025 Mar 4;46(2):326-334. doi: 10.1093/jbcr/irae150.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EHSG-KF | Other / unclassified | — | — |
| Subject | STSG | Unknown | — | — |
Indications
No indication recorded.