NCT02145130

Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects

A Phase I, Two Armed, Open, Prospective and Multicentre Study to Evaluate the Safety of Autologous Tissue-engineered Dermal Substitutes and Dermo-epidermal Skin Substitutes for the Treatment of Large Deep Partial and Full Thickness Skin Defects in Children and Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 1 Year – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is the evaluation of the safety of autologous tissue-engineered dermal substitutes "denovoDerm" (first arm) and dermo-epidermal skin substitutes "denovoSkin" (second arm) transplanted onto the wound bed in children and adults.

Conditions

• Burn Injury
• Soft Tissue Injury
• Skin Necrosis
• Scars
• Congenital Giant Nevus
• Skin Tumors

Interventions

Type	Name	Description
BIOLOGICAL	denovoDerm	Transplantation of an autologous tissue-engineered dermal substitute, covered with autologous split-thickness skin
BIOLOGICAL	denovoSkin	Transplantation of autologous tissue-engineered dermo-epidermal skin substitute, no additional coverage needed

Timeline

• Start date: 2014-05-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2014-05-22
• Last updated: 2021-09-08

Locations

2 sites across 1 country: Switzerland