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Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PHIT | Experimental | Human artificial skin created by tissue engineering, composed of a sheet of autologous adult differentiated skin keratinocytes and fibroblasts expanded in a biological fibrin-agarose matrix (PHIT). |
|
| PHITAH | Experimental | Human artificial skin created by tissue engineering, composed of a sheet of keratinocytes and differentiated autologous adult skin fibroblasts expanded in a biological fibrin-hyaluronic matrix (PHITAH). |
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| Skin Autograft | Active Comparator | Skin autograft. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PHITAH | Biological | Tissue Engineered Human Artificial Skin: Fibrin-Hyaluronic Acid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of autologous bioengineered skin | Incidence of adverse events related to investigational medicinal products | Through study completion, an average of 2 year |
| Efficacy of autologous bioengineered skin | Satisfaction of the graft assessed by doppler ultrasound and study of homeostasis | Through study completion, an average of 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Macarena Guijo Molero | Contact | 671 537 264 | 0034 | macarena.guijo@juntadeandalucia.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Costa del Sol | Recruiting | Marbella | Málaga | 29603 | Spain |
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| PHIT |
| Biological |
Human artificial skin created by tissue engineering: fibrin-agarose |
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| Skin Autograft | Biological | Skin Autograft |
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| Hospital U. Virgen de las Nieves | Recruiting | Granada | 18014 | Spain |
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| Hospital U. Virgen de la Victoria | Recruiting | Málaga | 29010 | Spain |
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| Hospital U. Virgen Macarena | Recruiting | Seville | 4109 | Spain |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018295 | Neoplasms, Basal Cell |
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