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

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ClinicalTrials.gov Identifier: NCT02090361
Recruitment Status : Recruiting
First Posted : March 18, 2014
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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.


Condition or disease Intervention/treatment Phase
Skin Graft Collagen -Elastin Matrix Procedure: skin graft Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Collagen-elastin Dermal Substitute in the Treatment of Loss of Cutaneous Substances With Skin Grafts
Actual Study Start Date : June 18, 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018


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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. Pain on the grafted site [ Time Frame: D7 ]
    Assessment of pain on the grafted site EVA at Day 7

  4. pain on the grafted site [ Time Frame: Day 15 ]
    Assessment of pain on the grafted site at Day 15

  5. pain on the grafted site [ Time Frame: Day 30 ]
    Assessment of pain at the grafted site EVA to D30

  6. pain on the grafted site [ Time Frame: Day 90 ]
    Assessment of pain at the grafted site EVA at D30

  7. pain on the grafted site [ Time Frame: Day 180 ]
    Assessment of pain at the grafted site EVA at Day 180

  8. pain on the grafted site [ Time Frame: Day 360 ]
    Assessment of pain at the grafted site EVA at Day 360

  9. tolerance of matriderm use [ Time Frame: Day 360 ]
    Occurrence within 360 days of a local complication requiring reoperation

  10. Area healed [ Time Frame: Day 7 ]
    Evaluation of the percentage of area healed at Day 7

  11. Area healed [ Time Frame: Day 15 ]
    Evaluation of the percentage of area healed at Day 15

  12. Area healed [ Time Frame: Day 30 ]
    Evaluation of the percentage of area healed at Day 30

  13. 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

  14. 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

  15. 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

  16. 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

  17. Aesthetic sequelae evaluation [ Time Frame: Day 90 ]
    Evaluation aesthetic sequelae by a committee of independent experts to study the photographs taken at day 90

  18. Aesthetic sequelae evaluation [ Time Frame: Day 180 ]
    Evaluation aesthetic sequelae by a committee of independent experts to study the photographs taken at day 180

  19. Aesthetic sequelae evaluation [ Time Frame: Day 360 ]
    Evaluation aesthetic sequelae by a committee of independent experts to study the photographs taken at day 360



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090361


Contacts
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Contact: Isabelle AUQUIT-AUCKBUR, Pr +3323288 ext 6621 isabelle.auquit-auckbur@chu-rouen.fr
Contact: Julien BLOT, M. +3323288 ext 8265 julien.blot@chu-rouen.fr

Locations
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France
CHU d'Amiens Recruiting
Amien, France
Contact: Raphael SINNA, Pr         
CHU de Caen Recruiting
Caen, France
Contact: Nathalie HANNOUZ, MD         
CHU de Lille Recruiting
Lille, France
Contact: Pierre GUERRECHI, MD         
UH Rouen Recruiting
Rouen, France, 76031
Contact: Isabelle AUQUIT-AUCKBUR, Pr    +3323288 ext 6621    isabelle.auquit-auckbur@chu-rouen.fr   
Principal Investigator: Isabelle AUQUIT-AUCKBUR, Pr         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Isabelle AUQUIT-AUCKBUR, Pr UH Rouen

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02090361     History of Changes
Other Study ID Numbers: 2013/008/HP
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by University Hospital, Rouen:
collagen -elastin matrix
skin graft
loss of cutaneous substance