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

Phase 1

Completed

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

• Registration Number: NCT02145130
• Lead Sponsor: University of Zurich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-22
• Primary Completion: 2021-03
• Study Completion: 2021-03
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-06
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to:

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

• Informed consent by patients/parents or other legal representatives

Exclusion Criteria

• Infected wounds or positive general microbiological swabs taken from the nose for multi-resistant germs
• Patients tested positive for HBV, HCV, syphilis or HIV
• Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin diseases, any kind of congenital defect of metabolism including diabetes)
• Coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen <LLN and / or at the Investigator's discretion
• Previous enrolment of the patient into the current study
• Participation of the patient in another study within 30 days preceding and during the present study
• Patients or parents/other legal representatives expected not to comply with the study protocol
• Suspicion of child abuse
• Pregnant or breast feeding females
• Contamination derived from biopsy which could interfere with patients health
• Due to patient derived variations, isolated cells from biopsy do not proliferate or proliferate insufficiently
• Skin substitute has not been released due to production specific deviations
• Patients allergic to amphotericin B and gentamicin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety	denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation	Assessment/reporting of local infection rate and graft take

Secondary Outcome Measures

Name	Time	Method
Adverse events	until 90 days post transplantation	Assessment/reporting of number of adverse events

Trial Locations

Locations (2)

University Children's Hospital Zurich: denovoDerm; 🇨🇭 Zurich, ZH, Switzerland

University Children's Hospital Zurich: denovoSkin; 🇨🇭 Zurich, ZH, Switzerland