Split thickness skin graft MedDRA version: 20.0 Level: LLT Classification code 10041667 Term: Split thickness skin graft System Organ Class: 100000004865
Conditions
Interventions
Product Name: CICAFAST
Pharmaceutical Form: Transdermal system
Sponsors
CHU de Nantes
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Compare wound healing’s rapidity of CICAFAST versus conventional treatment (JELONET®) in the treatment of STSG donor site. Evaluate the tolerance of CiCAFAST versus the conventional treatment (JELONET®) Compare the pain of the wound healing with CICAFAST versus conventional treatment (JELONET®) 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: D8, D11, D15, M3 and M6;Secondary end point(s): • The healing at D8 (or D11 and D15) judged by blind experts on picture. Healing is defined as 80% or more wound closure • Time to healing (in days) judged by blind physician observer • AE notification: case of infection (patients with 1 or 2 infections controlled by antibiotherapy will stay in the study. Patients with grade 3 or 4 infection will be withdrawn from the trial) and case of biological dressing (CICAFAST) rejection. • Evaluation of the quality of the wound healing by an observer (physician who will not do the patient surgery) at M3 and M6, OSAS scale will be used, by the patient (PSAS scale will be used) and blind expertise on picture by 2 external experts (Visual Analogue Scale 1 like normal skin to 10 the worst scar) and the results of scars’confocal microscopy at M3. A second evaluation of complete healing will be performed by two exterior independent experts evaluating the photographs taken until complete healing (Healing is defined as 80% or more wound closure). • Number of painful day/wound from the surgery until the complete healing | — |
Countries
France
Contacts
Public ContactDirection de la Recherche
CHU de Nantes
Outcome results
None listed