Efficacy of Collagen-elastin Dermal Substitute in the Treatment of Loss of Cutaneous Substances With Skin Grafts

Study Overview
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Brief Summary
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In reconstructive surgery , most losses of cutaneous substance require the use of a thin skin graft . This technique allows epidermization of the defect by applying a thin layer of autologous epidermis. It does not reconstitute the injured skin. Transplants cause retractile scars, adherent to the deep plan, that may require revision surgery . Since a decade , dermal matrices are mainly used in burned skin centers . The collagen -elastin matrix has the advantage to set up in the same operation that the skin graft and contain elastic fibers , two assets which improve the results of skin grafting. Objective: Evaluation of the clinical efficacy of the addition of a dermal matrix to skin graft on Skin Foldability, at day 360. Methodology: This is a multicenter randomized study (CHU Caen , Amiens, Rouen and Lille) Conduct of the study : The transplant will be performed according to the protocol defined between inter -region surgeons. The implementation of the dermal matrix will be in the same surgical technique as thin skin graft ( group 1 ) or the thin skin graft will be performed alone ( group 2) time . Evaluation Criteria Main : Skin Foldability ( Uf ) assessed grafted site will be compared to the opposite side ungrafted evaluated at Day 360 . Quantitative data will be measured by a cutometer Skin Elasticity Meter 580 (Courage and Khazaba Electronic GmbH). To achieve the main objective, it is planned to compare the ratio between Uf graft site and the opposite healthy site between two groups: skin + matrix graft , or skin graft only. Thus, the Wilcoxon test for independent samples will be used to settle bilateral formulation between the null hypothesis ( there is no difference between the two groups ) and the alternative hypothesis ( there is a difference between the two groups ) . In determining the overall risk of first species to 5% and the power of this test to detect the 90% expected under the alternative hypothesis difference should be the main criterion for evaluating at least 59 patients in each group so 118 patients total. Prospect If the contribution of a dermal matrix in loss of skin substances improves skin pliability and reduces pain , functional and aesthetic sequelae grafts thin skin , the dermal matrix may be proposed as a complementary treatment in these indications.

Official Title
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Efficacy of Collagen-elastin Dermal Substitute in the Treatment of Loss of Cutaneous Substances With Skin Grafts

Conditions
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Skin Graft, Collagen -Elastin Matrix

Intervention / Treatment
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* Procedure: skin graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged over 18 Signed informed consent Patients with loss of cutaneous substance of at least 15 cm2 Patient Without bone exposure, vascular, joint or tendon Eligibility for surgical treatment by skin graft Loss of substance trauma (avulsion, burns) or surgery (skin excision) Exclusion Criteria: Patient with a chronic wound Wound superinfected Patient unable for local or general skin graft Patient with an old or a recent skin injury strictly contralateral to the graft site. Patient unable to consent

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: skin graft with dermal matrix<br>Epidermization of the defect by applying a thin layer of autologous epidermis with addition of a dermal matrix | Procedure: skin graft<br>* Epidermization of the defect by applying a thin layer of autologous epidermis<br>|
| Placebo Comparator: skin graft - classic procedure<br>Epidermization of the defect by applying a thin layer of autologous epidermis | Procedure: skin graft<br>* Epidermization of the defect by applying a thin layer of autologous epidermis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Foldability ( Uf ) | Skin Foldability ( Uf ) will be assessed on grafted site compared to the opposite side ungrafted at day D360 . Quantitative data will be measured by a cutometer Skin Elasticity Meter 580 (Courage and Khazaba Electronic GmbH). | Day 360 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Foldability ( Uf ) | Skin Foldability ( Uf ) will be assessed on grafted site compared to the opposite side ungrafted at day D180 . Quantitative data will be measured by a cutometer Skin Elasticity Meter 580 (Courage and Khazaba Electronic GmbH) | Day 180 | 
| Skin Foldability ( Uf ) | Skin Foldability ( Uf ) will be assessed on grafted site compared to the opposite side ungrafted at day D90 . Quantitative data will be measured by a cutometer Skin Elasticity Meter 580 (Courage and Khazaba Electronic GmbH) | Day 90 | 
| Pain on the grafted site | Assessment of pain on the grafted site EVA at Day 7 | D7 | 
| pain on the grafted site | Assessment of pain on the grafted site at Day 15 | Day 15 | 
| pain on the grafted site | Assessment of pain at the grafted site EVA to D30 | Day 30 | 
| pain on the grafted site | Assessment of pain at the grafted site EVA at D30 | Day 90 | 
| pain on the grafted site | Assessment of pain at the grafted site EVA at Day 180 | Day 180 | 
| pain on the grafted site | Assessment of pain at the grafted site EVA at Day 360 | Day 360 | 
| tolerance of matriderm use | Occurrence within 360 days of a local complication requiring reoperation | Day 360 | 
| Area healed | Evaluation of the percentage of area healed at Day 7 | Day 7 | 
| Area healed | Evaluation of the percentage of area healed at Day 15 | Day 15 | 
| Area healed | Evaluation of the percentage of area healed at Day 30 | Day 30 | 
| Assessment of functional effects | Assessment of functional effects of the scar on the patient 's daily activities defined at Day 30 | Day 30 | 
| Assessment of functional effects | Assessment of functional effects of the scar on the patient 's daily activities defined at Day 90 | Day 90 | 
| Assessment of functional effects | Assessment of functional effects of the scar on the patient 's daily activities defined at Day 180 | Day 180 | 
| Assessment of functional effects | Assessment of functional effects of the scar on the patient 's daily activities defined at Day 360 | Day 360 | 
| Aesthetic sequelae evaluation | Evaluation aesthetic sequelae by a committee of independent experts to study the photographs taken at day 90 | Day 90 | 
| Aesthetic sequelae evaluation | Evaluation aesthetic sequelae by a committee of independent experts to study the photographs taken at day 180 | Day 180 | 
| Aesthetic sequelae evaluation | Evaluation aesthetic sequelae by a committee of independent experts to study the photographs taken at day 360 | Day 360 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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collagen -elastin matrix, skin graft, loss of cutaneous substance