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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
92
Epidermization of the defect by applying a thin layer of autologous epidermis
CHU d'Amiens
Amiens, France
CHU de Caen
Caen, France
CHU de Lille
Lille, France
UH Rouen
Rouen, France
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).
Time frame: Day 360
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)
Time frame: 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)
Time frame: Day 90
Pain on the grafted site
Assessment of pain on the grafted site EVA at Day 7
Time frame: D7
pain on the grafted site
Assessment of pain on the grafted site at Day 15
Time frame: Day 15
pain on the grafted site
Assessment of pain at the grafted site EVA to D30
Time frame: Day 30
pain on the grafted site
Assessment of pain at the grafted site EVA at D30
Time frame: Day 90
pain on the grafted site
Assessment of pain at the grafted site EVA at Day 180
Time frame: Day 180
pain on the grafted site
Assessment of pain at the grafted site EVA at Day 360
Time frame: Day 360
tolerance of matriderm use
Occurrence within 360 days of a local complication requiring reoperation
Time frame: Day 360
Area healed
Evaluation of the percentage of area healed at Day 7
Time frame: Day 7
Area healed
Evaluation of the percentage of area healed at Day 15
Time frame: Day 15
Area healed
Evaluation of the percentage of area healed at Day 30
Time frame: Day 30
Assessment of functional effects
Assessment of functional effects of the scar on the patient 's daily activities defined at Day 30
Time frame: Day 30
Assessment of functional effects
Assessment of functional effects of the scar on the patient 's daily activities defined at Day 90
Time frame: Day 90
Assessment of functional effects
Assessment of functional effects of the scar on the patient 's daily activities defined at Day 180
Time frame: Day 180
Assessment of functional effects
Assessment of functional effects of the scar on the patient 's daily activities defined at Day 360
Time frame: Day 360
Aesthetic sequelae evaluation
Evaluation aesthetic sequelae by a committee of independent experts to study the photographs taken at day 90
Time frame: Day 90
Aesthetic sequelae evaluation
Evaluation aesthetic sequelae by a committee of independent experts to study the photographs taken at day 180
Time frame: Day 180
Aesthetic sequelae evaluation
Evaluation aesthetic sequelae by a committee of independent experts to study the photographs taken at day 360
Time frame: Day 360
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.