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

August 29, 2017 updated by: University Hospital, Rouen

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 Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

118

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Amien, France
        • Recruiting
        • CHU d'Amiens
        • Contact:
          • Raphael SINNA, Pr
      • Caen, France
        • Recruiting
        • CHU de Caen
        • Contact:
          • Nathalie HANNOUZ, MD
      • Lille, France
        • Recruiting
        • CHU de Lille
        • Contact:
          • Pierre GUERRECHI, MD
      • Rouen, France, 76031
        • Recruiting
        • UH Rouen
        • Contact:
        • Principal Investigator:
          • Isabelle AUQUIT-AUCKBUR, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Foldability ( Uf )
Time Frame: Day 360
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 )
Time Frame: Day 180
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 )
Time Frame: Day 90
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
Time Frame: D7
Assessment of pain on the grafted site EVA at Day 7
D7
pain on the grafted site
Time Frame: Day 15
Assessment of pain on the grafted site at Day 15
Day 15
pain on the grafted site
Time Frame: Day 30
Assessment of pain at the grafted site EVA to D30
Day 30
pain on the grafted site
Time Frame: Day 90
Assessment of pain at the grafted site EVA at D30
Day 90
pain on the grafted site
Time Frame: Day 180
Assessment of pain at the grafted site EVA at Day 180
Day 180
pain on the grafted site
Time Frame: Day 360
Assessment of pain at the grafted site EVA at Day 360
Day 360
tolerance of matriderm use
Time Frame: Day 360
Occurrence within 360 days of a local complication requiring reoperation
Day 360
Area healed
Time Frame: Day 7
Evaluation of the percentage of area healed at Day 7
Day 7
Area healed
Time Frame: Day 15
Evaluation of the percentage of area healed at Day 15
Day 15
Area healed
Time Frame: Day 30
Evaluation of the percentage of area healed at Day 30
Day 30
Assessment of functional effects
Time Frame: Day 30
Assessment of functional effects of the scar on the patient 's daily activities defined at Day 30
Day 30
Assessment of functional effects
Time Frame: Day 90
Assessment of functional effects of the scar on the patient 's daily activities defined at Day 90
Day 90
Assessment of functional effects
Time Frame: Day 180
Assessment of functional effects of the scar on the patient 's daily activities defined at Day 180
Day 180
Assessment of functional effects
Time Frame: Day 360
Assessment of functional effects of the scar on the patient 's daily activities defined at Day 360
Day 360
Aesthetic sequelae evaluation
Time Frame: Day 90
Evaluation aesthetic sequelae by a committee of independent experts to study the photographs taken at day 90
Day 90
Aesthetic sequelae evaluation
Time Frame: Day 180
Evaluation aesthetic sequelae by a committee of independent experts to study the photographs taken at day 180
Day 180
Aesthetic sequelae evaluation
Time Frame: Day 360
Evaluation aesthetic sequelae by a committee of independent experts to study the photographs taken at day 360
Day 360

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Isabelle AUQUIT-AUCKBUR, Pr, UH Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2014

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

March 14, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimate)

March 18, 2014

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2013/008/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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