Basal Cell Carcinoma
Conditions
Brief summary
Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
Interventions
BIOLOGICALPHITAH
Tissue Engineered Human Artificial Skin: Fibrin-Hyaluronic Acid
BIOLOGICALPHIT
Human artificial skin created by tissue engineering: fibrin-agarose
BIOLOGICALSkin Autograft
Skin Autograft
Sponsors
Andalusian Network for Design and Translation of Advanced Therapies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients that give their informed consent for study participation. 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
1. Locally advanced basal cell carcinoma with evidence of tissue infiltration. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of autologous bioengineered skin | Through study completion, an average of 2 year | Incidence of adverse events related to investigational medicinal products |
| Efficacy of autologous bioengineered skin | Through study completion, an average of 2 year | Satisfaction of the graft assessed by doppler ultrasound and study of homeostasis |
Countries
Spain
Contacts
Primary ContactMacarena Guijo Molero
Outcome results
None listed