CompletedPhase 1

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

Switzerland12 participantsStarted 2014-05

Plain-language 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.

Who can participate

Age range1 Year – 70 Years

SexALL

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Inclusion criteria

✓. Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans
✓. Reconstructive cases (elective surgery): scar formation after burn injuries, congenital giant nevus, skin tumours

What they're measuring

Safety

Timeframe: denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation

Trial details

NCT IDNCT02145130

SponsorUniversity of Zurich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03

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