Status:
TERMINATED
Controlled 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
Lead Sponsor:
Nantes University Hospital
Conditions:
Split Thickness Skin Graft
Wound Healing
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Cell-based engineered skin substitutes are promising to treat difficult-to-heal acute and chronic wounds such as large/deep burns, ulcers resistant to conventional therapies or surgical wounds. Cultur...
Eligibility Criteria
Inclusion
- Female or male aged ≥18 years old
- For potentially childbearing female, only those with effective contraception (contraception pill, implant and intrauterine device) could be included
- Patient who need skin graft ( height equal to or greater than 100cm2 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
Exclusion
- Patients with an history of cancers except basal and squamous cell, cutaneous carcinoma.
- 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 stops 7 days before the surgery), with severe venous insufficiency, suffering of severe polyneuropathy, with known allergy to antibiotics,
- Patients with an allergic predisposition or known allergy to bovine collagen or silicone
- Patients receiving corticosteroids, immunosuppressive or cytotoxic agents unless treatment stops 4 weeks before the surgery
- Patients contraindicated with local anesthetic used in STSG process of his investigator center
- Patients with systemic infection (all grade defined by CTCAE Common Terminology Criteria for Adverse Event V4.03) at surgery visit will not be included in this trial because of the contraindication of the surgical gesture.
- Patient intolerant to the conventional treatment (JELONET®)
- Patient intolerant to URGO TUL®
- Patient intolerant to TELFA®
- Patient intolerant to the stretchable strip (HYPAFIX® or NYLEX®)
- Pregnant or breast-feeding women
- Patients participating in clinical trial
- Vulnerable people: persons deprived of liberty; under trusteeship or under curatorship
Key Trial Info
Start Date :
May 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03334656
Start Date
May 16 2018
End Date
July 15 2024
Last Update
August 12 2024
Active Locations (2)
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1
Chu de Nantes
Nantes, France, 44000
2
CHU de Nantes
Nantes, France, 44093