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

Study Overview
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Brief Summary
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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.

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. 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.

Official Title
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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

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 (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

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
Interventional Model Description: part of wound treated with /without dermal template
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 |
| --- | --- | --- |
| Scar quality as assessed for scar elasticity (experimental vs control area) as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS) | 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) |  | 5-7 days | 
| Epithelialisation (Subjective assessment by experienced observer) | 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) | Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire | 12 months | 
| Scar quality (As determined with subjective scar assessment scale (POSAS) | 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) | As measured for scar colour and pigmentation using DSM II ColorMeter | 3 and 12 months | 

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