MedTrace Logo

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

NCT02145130 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-09-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Hospital, Zürich

    collaborator OTHER

  • University of Zurich

    lead OTHER

Principal Investigators

  • Sophie Böttcher, PD Dr. med. · University Children's Hospital, Zurich

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02145130 on ClinicalTrials.gov