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

NCT02090361 | Completed

• 1 other identifier: 2013/0008/HP
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 4

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.

Conditions

Skin Graft; Collagen -Elastin Matrix

Keywords

collagen -elastin matrix; skin graft; loss of cutaneous substance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Skin Foldability ( Uf )

  Day 180

• Skin Foldability ( Uf )

  Day 90

• Pain on the grafted site

  D7

• pain on the grafted site

  Day 15

• pain on the grafted site

  Day 30

Study Arms (2)

skin graft with dermal matrix

EXPERIMENTAL

Epidermization of the defect by applying a thin layer of autologous epidermis with addition of a dermal matrix

Procedure: skin graft

skin graft - classic procedure

PLACEBO COMPARATOR

Epidermization of the defect by applying a thin layer of autologous epidermis

Interventions

skin graft PROCEDURE

Epidermization of the defect by applying a thin layer of autologous epidermis

skin graft with dermal matrix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (4)

CHU d'Amiens

Amiens, France

Location

CHU de Caen

Caen, France

Location

CHU de Lille

Lille, France

Location

UH Rouen

Rouen, 76031, France

Location

MeSH Terms

Interventions

Skin Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Isabelle AUQUIT-AUCKBUR, Pr

  UH Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 18, 2014
• Study Start: June 18, 2014
• Primary Completion: February 26, 2019
• Study Completion: February 26, 2019
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

FR (4)