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Skin wounds of Recessive Epidermolysis Bullosa Dystrophica (REBD) involve pain, superinfection, protein-losing, inflammation, and joint contractures are the bed of squamous cell carcinoma. There is no precise data on the kinetics of healing post-bullous erosions but clinical experience suggests that most epidermise in less than a month. Some, however, for unknown reasons, persist for several months. These chronic ulcers (UC), arbitrarily defined for this study as lasting more than three months are a source of major discomfort and could play a decisive role in the morbidity and mortality of the disease.
The aim of this study is to evaluate the efficacy of the amniotic membrane on the healing of chronic ulcers REBD on the percentage ulcerated surface re-epithelialised at 12 weeks (M3) from the start of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Dressing | Active Comparator | J0 to J42 : once a week, primary dressing with Mepitel® |
|
| Amniotic Membrane | Experimental | J0 to J42: once a week, Mepitel® and amniotic membrane (one or several depending on the graft size, so that the ulcer was completely covered with MAH). The last amniotic membrane is left in place. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amniotic Membrane | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of ulcerated area re-epithelialised | at 12 weeks from the start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| matthieu resche-rigon, MD-PHD | Contact | 142499742 | +33 | matthieu.resche-rigon@univ-paris-diderot.fr |
| emmanuelle BOURRAT, MD | Contact | emmanuelle.bourrat@rdb.aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint-Louis Hospital | Recruiting | Paris | Paris | 75010 | France |
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| ID | Term |
|---|---|
| D016108 | Epidermolysis Bullosa Dystrophica |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D004820 | Epidermolysis Bullosa |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D001684 | Biological Dressings |
| ID | Term |
|---|---|
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
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| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D012872 | Skin Diseases, Vesiculobullous |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |