Ongoing Clinical Trials for Micrographic Skin Surgery
There is currently 1 ongoing clinical trial exploring new treatment approaches for patients undergoing micrographic skin surgery, specifically those with basal cell carcinoma requiring reconstructive surgery. This trial is investigating the use of artificial skin made from patients’ own cells to improve healing outcomes after cancer removal.
Clinical trial locations
Study on Autologous Skin-Derived Keratinocytes and Fibroblasts for Patients with Basal Cell Carcinoma Undergoing Reconstructive Surgery
This clinical trial is being conducted in Spain and focuses on patients with basal cell carcinoma, a type of skin cancer that requires reconstructive surgery after removal. The study tests an innovative approach using artificial skin created from the patient’s own skin cells, which are grown in a laboratory to create living tissue that helps heal the skin after surgery.
Who can participate:
- Adults aged 18 years or older of any sex or racial background
- Patients with a confirmed diagnosis of basal cell carcinoma on the scalp, torso, or limbs
- Those whose cancer is too large to be closed with simple stitches or flap after surgery
- Patients requiring Mohs surgery, a specialized technique for removing skin cancer
- Women of childbearing potential and men who can father a child must agree to use effective birth control methods
- Must be able to provide informed consent after understanding the study requirements
Who cannot participate:
- Patients not undergoing Mohs surgery for basal cell carcinoma reconstruction
- Individuals outside specified age ranges
- People belonging to vulnerable populations requiring special protection
- Patients who do not meet safety and feasibility criteria for surgical implant
What the trial involves:
The trial evaluates a nanostructured autologous artificial skin, which is a specially designed tissue made from the patient’s own cells. This artificial skin is created using a fibrin matrix combined with either agarose or hyaluronic acid. Two versions are being tested: one expanded in a fibrin-agarose biological matrix and another in a fibrin-hyaluronic acid biological matrix. For comparison, traditional skin autografts are also being used.
During the surgery, the cancer is removed, and the artificial skin is implanted to help with healing. The study monitors how well the artificial skin attaches to the body, maintains its structure, and aids in the healing process. Follow-up assessments occur at three weeks after surgery and continue over a longer period to evaluate wound healing, pain levels, aesthetic appearance, and overall quality of life.
What is being tested:
The investigational treatment is nanostructured autologous artificial skin, a tissue-engineered skin substitute. This product is administered through surgical implantation and works by supporting attachment to the recipient tissue and promoting wound healing through re-epithelialization. The trial is currently in Phase II, evaluating both safety and effectiveness of this approach in helping patients heal after reconstructive surgery for skin cancer.
Summary
Currently, there is one clinical trial available for patients undergoing micrographic skin surgery, specifically targeting those with basal cell carcinoma requiring reconstructive procedures. This trial is located in Spain and represents an innovative approach to wound healing after cancer removal surgery. The study focuses on using the patient’s own cells to create artificial skin, which may offer advantages over traditional methods by potentially improving healing outcomes and reducing complications. Patients interested in participating should meet specific criteria related to their diagnosis, age, and ability to undergo Mohs surgery with reconstructive procedures.