The Safety of a Novel Acellular Dermal Template as Treatment for Burns and Scars

February 13, 2020 updated by: Association of Dutch Burn Centres

A Phase 1, Randomized, Multicentre Multinational Study to Evaluate the Safety and Feasibility of an Acellular Dermal Template Novomaix for the Treatment of Full Thickness Skin Defects in Human Patients.

In this study the safety and feasibility of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. We expect this treatment to be safe, and to provide better outcome regarding scar quality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Using dermal substitutes in combination with a split-thickness skin graft (STSG) is a well acknowledged therapy in burns and reconstructive surgery. Nevertheless, the ideal substitute is not available yet. We therefore want to investigate the use of an acellular dermal template (Novomaix), in combination with STSG, to treat these defects. Adult patients with acute (burn) wounds (group 1) and scars (group 2) will be included in this study. This phase I study aims to investigate the safety and feasibility of the use of this dermal matrix, with regard to graft take, epithelialisation and complications after transplantation. Moreover, scar quality will be evaluated.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

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

  • Germany
      • Berlin, Germany, 12683
        • Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie
  • Netherlands
    • Noord-Holland
      • Beverwijk, Noord-Holland, Netherlands, 1942 LE
        • Red Cross Hospital

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 years

    1. with acute burns/trauma wounds that require skin grafting (group 1) OR
    2. with scar problems requiring surgical treatment (group 2)
  • Full thickness skin defects of 50 cm2 or more, but <50% TBSA
  • Skin defects must be configured in such a way that two areas of 25 cm2 can be grafted
  • Informed consent by the patient

Exclusion Criteria:

  • Patients with infected wounds
  • Pregnant or breast feeding females
  • Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, diabetes, collagenoses, cancer)
  • Known allergy against porcine collagen or elastin
  • Patients who are expected (according to the responsible medical doctor) to be noncompliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
  • Previous enrolment of the patient into the current study

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dermal substitute with STSG
Novomaix dermal substitute in combination with STSG
Device: Novomaix dermal substitute in combination with STSG
Novomaix dermal substitute in combination with STSG
Other Names:
  • Novomaix
No Intervention: STSG alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft take (experimental vs control area)
Time Frame: 5-7 days postoperative
Subjective assessment of two experienced observers
5-7 days postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epithelialization
Time Frame: 5-7 and 18 ± 2 days days postoperative
Subjective assessment of two experienced observers
5-7 and 18 ± 2 days days postoperative
Complication rate
Time Frame: Up to 12 months postoperative
Measurement of re-operations, infection rate by culture swabs
Up to 12 months postoperative
Scar quality
Time Frame: 3 months
As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale
3 months
Scar quality
Time Frame: 6 months
As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale
6 months
Scar quality
Time Frame: 9 months
As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale
9 months
Scar quality
Time Frame: 12 months
As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale
12 months

Collaborators and Investigators

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

Sponsor

Association of Dutch Burn Centres

Collaborators

Seventh Framework Programme
Ernst Reichmann Tissue Biology Research Unit, Zürich

Investigators

  • Principal Investigator: Esther Middelkoop, Prof. dr., Red Cross Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 17, 2014

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ESG-09-2012
  • NL42113.094.12 (Other Identifier: ABR)

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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