Clinical trial NCT02090361: Efficacy of Collagen-elastin Dermal Substitute in the Treatment of Loss of Cutaneous Substances With Skin Grafts
Official title: Efficacy of Collagen-elastin Dermal Substitute in the Treatment of Loss of Cutaneous Substances With Skin Grafts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Skin Graft
Collagen -Elastin Matrix
Keywords: collagen -elastin matrix
skin graft
loss of cutaneous substance
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Skin Foldability ( Uf )
timeFrame: Day 360
Secondary outcomes:
measure: Skin Foldability ( Uf )
timeFrame: Day 180
measure: Skin Foldability ( Uf )
timeFrame: Day 90
measure: Pain on the grafted site
timeFrame: D7
measure: pain on the grafted site
timeFrame: Day 15
measure: pain on the grafted site
timeFrame: Day 30
measure: pain on the grafted site
timeFrame: Day 90
measure: pain on the grafted site
timeFrame: Day 180
measure: pain on the grafted site
timeFrame: Day 360
measure: tolerance of matriderm use
timeFrame: Day 360
measure: Area healed
timeFrame: Day 7
measure: Area healed
timeFrame: Day 15
measure: Area healed
timeFrame: Day 30
measure: Assessment of functional effects
timeFrame: Day 30
measure: Assessment of functional effects
timeFrame: Day 90
measure: Assessment of functional effects
timeFrame: Day 180
measure: Assessment of functional effects
timeFrame: Day 360
measure: Aesthetic sequelae evaluation
timeFrame: Day 90
measure: Aesthetic sequelae evaluation
timeFrame: Day 180
measure: Aesthetic sequelae evaluation
timeFrame: Day 360
Other outcomes:
Locations:
city: Amien
country: France
facility: CHU d'Amiens
city: Caen
country: France
facility: CHU de Caen
city: Lille
country: France
facility: CHU de Lille
city: Rouen
country: France
facility: UH Rouen
Study officials:
affiliation: UH Rouen
name: Isabelle AUQUIT-AUCKBUR, Pr
role: PRINCIPAL_INVESTIGATOR
References: