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

September 6, 2021 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8032
        • University Children's Hospital Zurich: denovoDerm
      • Zurich, ZH, Switzerland, 8032
        • University Children's Hospital Zurich: denovoSkin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 68 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: denovoDerm
Autologous tissue-engineered dermal substitute
Biological: denovoDerm
Transplantation of an autologous tissue-engineered dermal substitute, covered with autologous split-thickness skin
Experimental: denovoSkin
Autologous tissue-engineered dermo-epidermal skin substitute
Biological: denovoSkin
Transplantation of autologous tissue-engineered dermo-epidermal skin substitute, no additional coverage needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 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
denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: until 90 days post transplantation
Assessment/reporting of number of adverse events
until 90 days post transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

University Hospital, Zürich

Investigators

  • Principal Investigator: Sophie Böttcher, PD Dr. med., University Children's Hospital, Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 22, 2014

Study Record Updates

Last Update Posted (Actual)

September 8, 2021

Last Update Submitted That Met QC Criteria

September 6, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EuroSkinGraft / ESG-01-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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