Controlled and double blind comparison of a traditional dressing versus a biologic dressing composed of fetal fibroblasts and keratinocytes in association with a collagen matrix on skin donor sites

Phase 1

• Conditions: Split thickness skin graft; MedDRA version: 20.0Level: LLTClassification code 10041667Term: Split thickness skin graftSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2016-003997-41-FR
• Lead Sponsor: CHU de Nantes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-20
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Female or male aged =18 years old
For potentially childbearing female effective contraception is required
Patient who need skin graft ( height from 100cm2 to 200cm2 and thickness 1.2mm) after surgery excision
Patients with social security
Patients able to understand and follow the trial instructions
Patients who have signed an informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

Patients suffering from uncontrolled metabolic disease ( for instance diabete), from a psychiatric disorder not treated, with severe arteritis of lower and/or upper limbs, treated with anticoagulant (unless treatment stop 7 days before the surgery), with severe venous insufficiency, suffering of severe polyneuropathy, with known allergy to bovine protein, receiving corticosteroids, immunosuppressive or cytotoxic agents
Grade 2, 3 or 4 infections at the inclusion visit
Patient intolerant to the conventional treatment (JELONET®)
Patient intolerant to the stretchable strip (NYLEX®)
Pregnant or breast-feeding women
Patients participating in interventional clinical trial
Vulnerable people : persons deprived of liberty; under trusteeship or under curatorship

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Compare wound healing of CICAFAST versus conventional treatment (JELONET®) in the treatment of STSG donor site at D8.;Secondary Objective: Evaluate the concordance between the healing at D8 (or D11 and D15) judged by blind physician observer and the evaluation of healing by two experts using photographs<br>Compare wound healing’s rapidity of CICAFAST versus conventional treatment (JELONET®) in the treatment of STSG donor site.<br>Evaluate the tolerance of CiCAFAST versus the conventional treatment (JELONET®)<br>Compare the pain of the wound healing with CICAFAST versus conventional treatment (JELONET®)<br>Compare the quality of the wound healing with CICAFAST versus conventional treatment (JELONET®) ;Primary end point(s): The number of complete healing at D8 judged by blind physician observer. Healing is defined as 80% or more wound closure (determined by a ruler). ;Timepoint(s) of evaluation of this end point: D8