A Study to Evaluate the Efficacy of an Acellular Dermal Template for the Treatment of Full Thickness Skin Defects

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

A Phase 2, Intra-patient Randomised Controlled Multicentre International Study to Evaluate the Efficacy of an Acellular Dermal Template Novomaix for the Treatment of Full Thickness Skin Defects

In this study the efficacy 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. The investigators expect this treatment to provide better outcome regarding scar quality.

Study Overview

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. Patients with with full thickness skin defects will be included in this study. This phase II study aims to investigate the efficacy of the use of this dermal matrix, with regard to scar quality as determined for elasticity at 3 months after treatment. Moreover, graft take (5-7 days after treatment), epithelialisation (5-7 days and 2-3 weeks), and scar quality (3 and 12 months after treatment, as determined for elasticity, colour/pigmentation, and using a subjective scar assessment scale) will be evaluated.

Study Type

Interventional

Enrollment (Actual)

11

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

      • Berlin, Germany, 12683
        • Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie
    • Noord-Holland
      • Beverwijk, Noord-Holland, Netherlands, 1942 LE
        • Red Cross Hospital
      • Zurich, Switzerland
        • Children's Hospital Department of Surgery Kinderspital Zurich

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 years (for Zurich: ≤ 18 years)
  • Full thickness skin defects configured in such a way that two comparable and measurable areas can be grafted, both of minimally 3x3 cm
  • ≤ 50% TBSA full thickness skin defects at time of intervention
  • Informed consent by the patient and/or legal representatives.

Exclusion Criteria:

  • Patients with infected wounds
  • Full thickness skin wounds located in face and/or genitals will not be included
  • Pregnant or breast feeding females
  • Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, uncontrolled diabetes, treatment with corticoid therapy, collagenoses, cancer)
  • Known allergy against porcine collagen or elastin
  • Patients that are expected (according to the responsible medical doctor) to be non-compliant 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
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
Scar quality as assessed for scar elasticity (experimental vs control area) as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)
Time Frame: 3 months post-operative
Scar elasticity as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)
3 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft take (Subjective assessment by experienced observer)
Time Frame: 5-7 days
5-7 days
Epithelialisation (Subjective assessment by experienced observer)
Time Frame: 5-7 days and 2-3 weeks post-operative
Subjective assessment by experienced observer
5-7 days and 2-3 weeks post-operative
Scar quality (Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire)
Time Frame: 12 months
Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire
12 months
Scar quality (As determined with subjective scar assessment scale (POSAS)
Time Frame: 3 and 12 months
As determined with subjective scar assessment scale (POSAS)
3 and 12 months
Scar quality (As measured for scar colour and pigmentation using DSM II ColorMeter)
Time Frame: 3 and 12 months
As measured for scar colour and pigmentation using DSM II ColorMeter
3 and 12 months

Collaborators and Investigators

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

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.

Helpful Links

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

February 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

February 26, 2015

First Posted (Estimate)

February 27, 2015

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

Other Study ID Numbers

  • ESG-NVM-II-2014
  • NL50542.094.14 (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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