Comparative Assessment of Adjuvant Effect of Cultured Epidermal Autografts Versus Skin Allografts on Wound Healing of Burns Treated With Widely Expanded Skin Autograft Using Meek Micrografting Technique MEEKADEAU

Study Overview
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Brief Summary
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The investigators intend to conduct a comparative, monocentric prospective double-blind study with intra-subject randomization, to compare the results on wound healing of 2 adjuvant treatments to Meek micrografting technique : Cultured Epidermal Autografts and cryopreserved skin allografts.

Detailed Description
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10 patients presenting burn wounds over 50% of total body surface area, including at least 40 % of deep burns, will be enrolled.

Official Title
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Comparative Assessment of Adjuvant Effect of Cultured Epidermal Autografts Versus Skin Allografts on Wound Healing of Burns Treated With Widely Expanded Skin Autograft Using Meek Micrografting Technique MEEKADEAU

Conditions
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Burn Wounds

Intervention / Treatment
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* Procedure: cryopreserved skin allografts.
* Procedure: Cultured Epidermal Autografts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females between 18 to 60 years of age Burns > 50% Total Body Surface Area (TBSA), including deep burns > 40% TBSA (deep partial thickness and full thickness burns). Patients presenting two 300 cm² (30x10cm) non adjacent burn wound areas, of similar depth assessed by Laser Doppler Imaging, on body anterior side, functional areas excepted. Written informed consent, signed by patient or legal representative (if patient unable to sign). Negative pregnancy test Exclusion Criteria: Chemical or electric burns Short delay life threatening disease, by itself or when associated with burns. Chronic systemic steroïd intake, Pre-existing diseases interfering with wound healing : inherited connective tissue disorder (Ehlers Danlos syndrome, Marfan syndrome), Epidermolysis Bullosa. Medical treatment interfering with wound healing (retinoids..). Prisonners Pregnant women Patient under guardianship. Participation in another investigational trial within this trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: gp2<br>Cultured Epidermal Autografts | Procedure: Cultured Epidermal Autografts<br> <br> |
| Active Comparator: gp1<br>cryopreserved skin allografts. | Procedure: cryopreserved skin allografts.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIME OF HEALING | to compare wound healing speed on the 2 treated areas, considering epithelialization rate until complete wound healing. | 2 YEARS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QUALITY OF HEALING | to assess the quality of wound healing and scar maturation. | 2 YEARS |