Study of an Artificial Human Skin Medicine for Patients With Basal Cell Carcinoma Undergoing Reconstructive Surgery
NCT ID: NCT05234658
Last Updated: 2023-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
21 participants
INTERVENTIONAL
2022-01-21
2024-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PHIT
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).
PHIT
Human artificial skin created by tissue engineering: fibrin-agarose
PHITAH
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).
PHITAH
Tissue Engineered Human Artificial Skin: Fibrin-Hyaluronic Acid
Skin Autograft
Skin autograft.
Skin Autograft
Skin Autograft
Interventions
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PHITAH
Tissue Engineered Human Artificial Skin: Fibrin-Hyaluronic Acid
PHIT
Human artificial skin created by tissue engineering: fibrin-agarose
Skin Autograft
Skin Autograft
Eligibility Criteria
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Inclusion Criteria
2. Adult (18 years of age or older), of any sex and racial origin.
3. Clinical and dermatoscopic diagnosis of basal cell carcinoma with lesions on the scalp, torso or extremities, within a certain size that do not allow for surgical closure by direct suture or flaps. Namely, indication for Mohs surgery.
4. Women with childbearing age or men capable of producing a child, should commmit to use contraceptives of medically proven efficacy.
Exclusion Criteria
2. Lesions in the face.
3. Injuries requiring urgent surgical intervention.
4. Infected lesions, necrosis, scarcely vascularized injuries or other complications that may interfere with healing and/or integrity of the graft.
5. Injuries that have received treatment with radiotherapy.
6. Contraindication for Mohs surgery.
7. Known allergies to Biobrane dressing.
8. Pregnant or breastfeeding women.
9. Coexistence of any other pathology that, in the investigator's opinion, could compromise the healing process or interfere with protocol follow-up.
10. Participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies.
18 Years
ALL
No
Sponsors
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Andalusian Network for Design and Translation of Advanced Therapies
OTHER
Responsible Party
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Locations
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Hospital Costa del Sol
Marbella, Málaga, Spain
Hospital U. Virgen de las Nieves
Granada, , Spain
Hospital U. Virgen de la Victoria
Málaga, , Spain
Hospital U. Virgen Macarena
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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Magdalena Troya
Role: primary
Salvador Arias
Role: primary
Ricardo Bosch
Role: primary
David Moreno
Role: primary
Other Identifiers
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NanoGSkin-CB-2019
Identifier Type: -
Identifier Source: org_study_id
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