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 - CICAFAST

CHU de Nantes0 个研究点目标入组 38 人开始时间: 2017年10月20日最近更新: 2018年1月8日

适应症

试验速览

暂无简介。

•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

•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

发起方