EPIDERMOLYSIS BULLOSA Clinical Trial
Official title:
A Comparative Open-Label Multicentre Clinical Trial To Assess The Efficacy And Safety Of A New Therapy With Cultured Chimeric Skin For The Treatment Of Skin Lesions In Patients With Epidermolysis Bullosa
A phase II, comparative, open label, prospective, multicentre clinical trial where each patient will undergo two procedures; implant of a patch of cultured chimeric skin (experimental therapy) in a half of the skin lesion and an occlusive non-adherent dressing (control) in the other half for 12 months of follow-up in two Spanish centres.
Reconstruction of interdigital commisures in patients with severe skin syndactyly using
laminar grafts that will be uniformly and systematically taken with an electrical or
compressed air dermatome on an aseptic area and with the same extent and depth in microns in
all patients.
Immediately after the surgical procedure, a patch of cultured chimeric skin (experimental
therapy) will be implanted in a half of the skin defect of the patient, and an occlusive non
- adherent dressing (control) will be implanted in the other half.
Patients will initially be followed up every two days until epithelisation occurs
(approximately 21 days after surgery) and at 3,8,and 12 months of follow-up.
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