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Study of an Artificial Human Skin Medicine for Patients With Basal Cell Carcinoma Undergoing Reconstructive Surgery.
EU CTIS ID: 2024-515235-29-00
What this study is testing
Safety: To confirm that the use of nanostructured autologous artificial skin based on a fibrin matrix combined with agarose or hyaluronic acid is safe, based on the incidence of adverse events related to the investigational products, both during their implantation, as during subsequent follow-up. Feasibility: To verify that the surgical implant with nanostructured autologous artificial skin based on a fibrin matrix combined with agarose or hyaluronic acid is feasible in terms of its suturability and ability to attach to the recipient tissue, maintain its integrity and facilitate the re-epithelialization of the surgical wound.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 commit to use contraceptives of medically proven efficacy.
You likely can't join if
- Locally advanced basal cell carcinoma with evidence of deep tissue infiltration (fascia, muscle…).
- 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.
- Lesions in the face., except for frontal-lateral area and the temple.
- Injuries requiring urgent surgical intervention.
- Infected, necrotic, scarcely vascularized injuries or other complications that may interfere with healing and/or integrity of the graft.
See the full eligibility criteria
- 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 commit to use contraceptives of medically proven efficacy.
- Locally advanced basal cell carcinoma with evidence of deep tissue infiltration (fascia, muscle…).
- 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.
- Lesions in the face., except for frontal-lateral area and the temple.
- Injuries requiring urgent surgical intervention.
- Infected, necrotic, 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 antibiotics that could be part of the impurities in the PHA manufacturing process (gentamicin and amphotericin B).
- Pregnant or breastfeeding women.
- Coagulation disorders that make the healing process of the injury difficult.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.