Status:
UNKNOWN
Study of an Artificial Human Skin Medicine for Patients With Basal Cell Carcinoma Undergoing Reconstructive Surgery
Lead Sponsor:
Andalusian Network for Design and Translation of Advanced Therapies
Conditions:
Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
Eligibility Criteria
Inclusion
- Patients that give their informed consent for study participation.
- Adult (18 years of age or older), of any sex and racial origin.
- 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.
- Women with childbearing age or men capable of producing a child, should commmit to use contraceptives of medically proven efficacy.
Exclusion
- Locally advanced basal cell carcinoma with evidence of tissue infiltration.
- Lesions in the face.
- Injuries requiring urgent surgical intervention.
- Infected lesions, necrosis, scarcely vascularized injuries or other complications that may interfere with healing and/or integrity of the graft.
- Injuries that have received treatment with radiotherapy.
- Contraindication for Mohs surgery.
- Known allergies to Biobrane dressing.
- Pregnant or breastfeeding women.
- Coexistence of any other pathology that, in the investigator's opinion, could compromise the healing process or interfere with protocol follow-up.
- Participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies.
Key Trial Info
Start Date :
January 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05234658
Start Date
January 21 2022
End Date
December 1 2024
Last Update
November 8 2023
Active Locations (4)
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1
Hospital Costa del Sol
Marbella, Málaga, Spain, 29603
2
Hospital U. Virgen de las Nieves
Granada, Spain, 18014
3
Hospital U. Virgen de la Victoria
Málaga, Spain, 29010
4
Hospital U. Virgen Macarena
Seville, Spain, 4109