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

Skin Graft Clinical Trial

— MATRIGREFFE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02090361
• Other study ID #: 2013/008/HP
• Status: Recruiting
• Phase: Phase 3
• First received: March 14, 2014
• Last updated: August 29, 2017
• Start date: June 18, 2014
• Est. completion date: June 2018

Study information

• Verified date: August 2017
• Source: University Hospital, Rouen
• Contact: Isabelle AUQUIT-AUCKBUR, Pr
• Phone: +3323288
• Email: isabelle.auquit-auckbur[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Collagen -Elastin Matrix
• Skin Graft

Intervention

Procedure:
• skin graft
Epidermization of the defect by applying a thin layer of autologous epidermis

Locations

Country	Name	City	State
France	CHU d'Amiens	Amien
France	CHU de Caen	Caen
France	CHU de Lille	Lille
France	UH Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Pain on the grafted site	Assessment of pain on the grafted site EVA at Day 7	D7
Secondary	pain on the grafted site	Assessment of pain on the grafted site at Day 15	Day 15
Secondary	pain on the grafted site	Assessment of pain at the grafted site EVA to D30	Day 30
Secondary	pain on the grafted site	Assessment of pain at the grafted site EVA at D30	Day 90
Secondary	pain on the grafted site	Assessment of pain at the grafted site EVA at Day 180	Day 180
Secondary	pain on the grafted site	Assessment of pain at the grafted site EVA at Day 360	Day 360
Secondary	tolerance of matriderm use	Occurrence within 360 days of a local complication requiring reoperation	Day 360
Secondary	Area healed	Evaluation of the percentage of area healed at Day 7	Day 7
Secondary	Area healed	Evaluation of the percentage of area healed at Day 15	Day 15
Secondary	Area healed	Evaluation of the percentage of area healed at Day 30	Day 30
Secondary	Assessment of functional effects	Assessment of functional effects of the scar on the patient 's daily activities defined at Day 30	Day 30
Secondary	Assessment of functional effects	Assessment of functional effects of the scar on the patient 's daily activities defined at Day 90	Day 90
Secondary	Assessment of functional effects	Assessment of functional effects of the scar on the patient 's daily activities defined at Day 180	Day 180
Secondary	Assessment of functional effects	Assessment of functional effects of the scar on the patient 's daily activities defined at Day 360	Day 360
Secondary	Aesthetic sequelae evaluation	Evaluation aesthetic sequelae by a committee of independent experts to study the photographs taken at day 90	Day 90
Secondary	Aesthetic sequelae evaluation	Evaluation aesthetic sequelae by a committee of independent experts to study the photographs taken at day 180	Day 180
Secondary	Aesthetic sequelae evaluation	Evaluation aesthetic sequelae by a committee of independent experts to study the photographs taken at day 360	Day 360