An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns

Study Overview
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Brief Summary
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The purpose of the study is to compare an acellular epithelial skin substitute with autologous split-thickness skin grafts (STSGs) in deep partial-thickness burns. The objective is to evaluate skin quality and scar formation by using subjective and objective burn scar assessments in order to present valuable data for another additional option of wound coverage in deep partial-thickness burns. The investigators hypothesized that the acellular epithelial skin substitute is at least not inferior to autologous skin grafts.

Official Title
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A Prospective Noninferiority Trial to Compare an Acellular Epithelial Skin Substitute With Autologous Split-thickness Skin Grafts in Deep Partial-thickness Burns

Conditions
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Wound Healing, Scar Formation

Intervention / Treatment
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* Device: Wound coverage by acellular skin substitute
* Device: Autologous skin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years of age verified deep partial-thickness burns early tangential excision of burn wound (3-5 days after trauma) Exclusion Criteria: Pregnancy ABSI-Score >13 Active tumor or immune-mediated disease Patient refusal

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acellular skin substitute<br> | Device: Wound coverage by acellular skin substitute<br>* Burn wounds are covered by an acellular skin substitute and remains 10-14 days that peals away in line with re-epithelialisation<br>* Other names: Suprathel;|
| Active Comparator: Autologous skin graft<br> | Device: Autologous skin<br>* Matched burn wound is covered by autologous skin after tangential excision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (in days +/- standarddeviation) to complete re-epithelialisation in acellular skin substitue area versus autologous skin | Time to complete re-epithelialisation measured in days after surgery | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin quality- ratio acellular skin substitute/healthy skin versus ratio autologous skin/healthy skin | Quality of the skin is measured two-fold: Subjective scar scors: Vancouver Scar Scale, Patient and Observer Scar Scale Objective scar evaluation by a non-invasive suction device, that measures viscoelastic parameter. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burn wound, Skin substitutes, Scar formation, Skin quality, Split-thickness skin graft