Study on Autologous Skin-Derived Keratinocytes and Fibroblasts for Patients with Basal Cell Carcinoma Undergoing Reconstructive Surgery

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What is this study about?

This clinical trial is focused on studying a type of skin cancer known as basal cell carcinoma, which often requires reconstructive surgery. The trial is testing a new treatment that uses a special kind of artificial skin made from a patient’s own skin cells. These cells are grown in a lab to create a living tissue that can be used to help heal the skin after surgery. The treatment involves two different types of this artificial skin: one is expanded in a fibrin-agarose biological matrix, and the other in a fibrin-hyaluronic acid biological matrix. These are referred to by their code names, PHIT and PHITAH, respectively. Additionally, a traditional skin autograft, which is a transplant of the patient’s own skin, is also being used for comparison.

The purpose of the study is to evaluate the safety and effectiveness of these treatments. Participants will undergo surgery to remove the cancer, and the artificial skin will be implanted to help with healing. The study will monitor how well the artificial skin attaches to the body, maintains its structure, and aids in the healing process. The trial will also look at any side effects that may occur during and after the treatment. The study will last for a period of time during which participants will have regular follow-up visits to check on their progress.

Throughout the study, researchers will assess various aspects of healing, such as how quickly the skin heals, the level of pain experienced, and the overall appearance of the skin after treatment. They will also evaluate the quality of life of participants and compare the efficiency of the different treatments. This trial aims to provide valuable information on whether these new artificial skin treatments can be a safe and effective option for patients undergoing surgery for basal cell carcinoma.

1 joining the study

Upon joining the study, informed consent is required. This involves understanding the study’s purpose and agreeing to participate.

Eligibility criteria include being an adult with a diagnosis of basal cell carcinoma requiring Mohs surgery, and agreeing to use effective contraceptives if applicable.

2 preparation for surgery

Before the surgery, a detailed assessment of the skin condition is conducted. This includes clinical and dermatoscopic evaluations to confirm the diagnosis and plan the surgical procedure.

3 surgical procedure

The surgical procedure involves the use of a nanostructured autologous artificial skin based on a fibrin matrix combined with agarose or hyaluronic acid.

The artificial skin is implanted to cover the surgical wound. This process is known as implantation.

4 post-surgery follow-up

After the surgery, the healing process is monitored. This includes checking for any adverse events such as infection or graft loss.

The ability of the artificial skin to adhere to the tissue and facilitate healing is evaluated.

5 evaluation of healing

Three weeks after the surgery, the percentage of wound healing is assessed. This includes the time taken for stitches to be removed and complete healing to occur.

Pain levels and the aesthetic appearance of the healed area are also evaluated.

6 long-term assessment

Long-term assessments include evaluating the quality of life and any structural changes in the skin using various techniques such as doppler ultrasound and skin biopsies.

The efficiency of the treatment is analyzed by comparing the outcomes of the different types of artificial skin used in the trial.

Who Can Join the Study?

Patients must give their informed consent to participate in the study. This means they agree to join the study after understanding what it involves.
Participants must be adults, which means they are 18 years of age or older. People of any sex and racial background can join.
Participants must have a clinical and dermatoscopic diagnosis of basal cell carcinoma. This is a type of skin cancer. The cancer should be on the scalp, torso, or limbs and be of a size that cannot be closed with a simple stitch or flap after surgery.
The patient must need Mohs surgery, a special technique used to remove skin cancer.
Women who can have children or men who can father a child must agree to use effective birth control methods.

Who Cannot Join the Study?

Patients who are not undergoing reconstructive skin surgery for basal cell cancer, specifically Mohs surgery, cannot participate.
Patients who are not within the specified age ranges cannot participate. The age ranges are not specified here, but they are important for eligibility.
Patients who belong to a vulnerable population, which means groups that might need special protection, cannot participate.
Patients who do not meet other unspecified criteria related to the safety and feasibility of the surgical implant cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Hospital Universitario Virgen Macarena	Sevilla	Spain
Hospital Costa del Sol	Marbella	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	21.01.2022

Trial locations

Investigated drugs:

Skin Autograft

Nanostructured Autologous Artificial Skin: This is a specially designed artificial skin made from a patient’s own cells. It is created using a fibrin matrix, which is a protein that helps in blood clotting, combined with either agarose or hyaluronic acid. The purpose of this artificial skin is to be used in reconstructive surgery for patients with basal cell carcinoma, a type of skin cancer. The trial aims to ensure that this artificial skin is safe to use and can effectively attach to the patient’s tissue, maintain its structure, and help heal the surgical wound.

Basal Cell Carcinoma – Basal cell carcinoma is a type of skin cancer that begins in the basal cells, which are found in the outer layer of the skin. It often appears as a slightly transparent bump on the skin, though it can take other forms. This cancer grows slowly and is most commonly found on areas of the skin that are frequently exposed to the sun, such as the head and neck. While it rarely spreads to other parts of the body, it can cause significant local damage if not treated. Over time, the affected area may develop into a sore that does not heal, or it may bleed, ooze, or crust. The progression of basal cell carcinoma is typically slow, but it can become more invasive if left untreated.

Trial ID:

2024-515235-29-00

Protocol code:

NanoGSkin/CB/2019

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Autologous Skin-Derived Keratinocytes and Fibroblasts for Patients with Basal Cell Carcinoma Undergoing Reconstructive Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?