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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CX501 | Experimental | Cultured chimeric skin |
|
| Non adherent dressing | Active Comparator | Occlusive non adherent dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CX501 | Drug | Cultured chimeric skin |
| |
| Occlusive non adherent dressing |
| Measure | Description | Time Frame |
|---|---|---|
| Time to epithelization | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Fibroblast persistence | 3, 8 and 12 months | |
| Incidence of Adverse Events | 12 months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Carlos López, MD | Hospital La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Mir-Mir | Barcelona | Spain | ||||
| Hospital La Paz |
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| ID | Term |
|---|---|
| D004820 | Epidermolysis Bullosa |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
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| Device |
Application of an occlusive non adherent dressing in the skin donor site |
|
| Madrid |
| Spain |
| D030342 | Genetic Diseases, Inborn |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012872 | Skin Diseases, Vesiculobullous |