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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Full Thickness Skin Defects

Intervention / Treatment
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* Device: Novomaix dermal substitute in combination with STSG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years with acute burns/trauma wounds that require skin grafting (group 1) OR 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermal substitute with STSG<br>Novomaix dermal substitute in combination with STSG | Device: Novomaix dermal substitute in combination with STSG<br>* Novomaix dermal substitute in combination with STSG<br>* Other names: Novomaix;|
| No Intervention: STSG alone<br>STSG alone | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound healing, wound closure, burns, dermal substitute, scar quality, reconstruction