Study on the Safety and Effectiveness of EHSG-KF for Treating Full-Thickness Skin Defects in Adults and Children

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What is this study about?

This clinical trial is focused on studying a new treatment for people with full-thickness skin defects, which are deep wounds that affect all layers of the skin. These defects can occur in both adults and children due to various reasons such as scars, benign skin tumors, or injuries. The treatment being tested is called EHSG-KF, a special type of skin graft made from a bilayer engineered collagen hydrogel that includes the patient’s own skin cells, specifically keratinocytes and fibroblasts. This new treatment will be compared to the traditional method of using autologous split-thickness skin grafts (STSG), which involves taking a thin layer of skin from another part of the patient’s body.

The purpose of the study is to evaluate how effective and safe the EHSG-KF treatment is compared to the traditional STSG method. Participants in the study will receive both types of skin grafts, and the healing process will be monitored over time. The study will look at various aspects of healing, such as the quality of the scar, using tools like the POSAS questionnaire, which helps assess the appearance and feel of the scar. The study will also check for any signs of infection and other side effects throughout the healing process.

Participants will be followed for a period of time to see how well the skin heals and to compare the results of the new treatment with the traditional method. The study aims to provide valuable information on whether the EHSG-KF treatment can offer a better or safer option for treating deep skin wounds. This research could potentially lead to improved outcomes for patients with significant skin defects.

1 enrollment and consent

Upon joining the study, the patient will provide signed informed consent, either personally or through a legally authorized representative if underage. This consent confirms understanding and agreement to participate in the trial.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying the presence of large full-thickness skin defects that require coverage after excision of certain conditions, such as scars or benign skin tumors.

3 treatment allocation

The patient will be randomly assigned to receive either the new skin graft product, EHSG-KF, or the standard treatment, known as autologous split-thickness skin grafts (STSG).

4 grafting procedure

The grafting procedure will be performed, applying the assigned treatment to the skin defect. The EHSG-KF is a hydrogel-based skin graft composed of the patient’s own skin cells, applied directly to the skin.

5 post-grafting follow-up

The patient will attend several follow-up visits to monitor the healing process and assess the quality of the scar. These visits will occur at specific intervals: 6-10 days, 21 days, 28 days, 90 days, and 1 year after the grafting procedure.

6 scar quality assessment

At each follow-up visit, the quality of the scar will be evaluated using various methods, including the POSAS questionnaire, which assesses factors like pain, itching, and appearance. Additional tools like the Cutometer and DSM ColorMeter may be used to measure skin properties.

7 safety monitoring

Throughout the trial, the patient will be monitored for any signs of infection or adverse events. These will be assessed and reported during each visit to ensure the patient’s safety.

8 quality of life assessment

At the 1-year follow-up, the patient’s quality of life will be assessed using specific questionnaires, such as the EQ-5D and PedsQL, to understand the impact of the treatment on daily living.

Who Can Join the Study?

Must be at least 1 year old.
Have large full-thickness skin defects that need covering after removal of:
- Scars
- Non-cancerous skin growths (like neurofibroma)
- Skin moles (like giant nevus)
- Gender reassignment surgery
- Soft tissue damage after an injury
- Soft tissue damage after an infection and cleaning (like necrotizing fasciitis, hidradenitis suppurativa, purpura fulminans)
- Flap donor site (like radial forearm flap)
Minimum area needing coverage (not including head and neck for study patients in The Netherlands):
- For ages 1-5 years: at least 9 cm²
- For ages 6-16 years: at least 25 cm²
- For ages over 16 years: at least 45 cm²
Must have signed informed consent from the patient or their parents/legal representative.

Who Cannot Join the Study?

Patients with infections at the site of the skin defect. An infection is when germs like bacteria or viruses cause harm to the body.
Patients with autoimmune diseases. These are conditions where the body’s defense system attacks its own cells.
Patients who are pregnant or breastfeeding.
Patients with cancer that is not in remission. Remission means the cancer is not active or growing.
Patients who have had another clinical trial treatment within the last 30 days. A clinical trial is a research study to test new treatments.
Patients with allergies to the materials used in the study treatment.
Patients with blood clotting disorders. These are conditions where the blood does not clot properly, which can lead to excessive bleeding.
Patients with severe heart, liver, or kidney disease. These are serious conditions affecting major organs in the body.
Patients who are unable to follow the study procedures or instructions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliera Santobono Pausilipon	Naples	Italy
Rode Kruis Ziekenhuis B.V.	Beverwijk	The Netherlands
Azienda Ospedaliera di Padova	Padua	Italy
Vxecs Umynqfaeunlf	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.02.2018
The Netherlands	Not recruiting	01.02.2018

Trial locations

Investigated drugs:

Bilayer Engineered Collagen Hydrogel-Based Skin Graft Composed Of Autologous Keratinocytes And Fibroblasts

EHSG-KF is an autologous bio-engineered dermo-epidermal skin substitute. This means it is a type of skin graft made from the patient’s own cells. It is designed to help heal large, deep wounds by replacing the damaged skin with new, healthy skin. The goal of using EHSG-KF is to improve the quality of the scar that forms after the wound heals, making it look and feel more like normal skin.

STSG (Split-Thickness Skin Grafts) are a traditional method used to treat large skin wounds. In this process, a thin layer of skin is taken from another part of the patient’s body and placed over the wound. This helps the wound heal by covering it with new skin. The skin used in STSG can be either unmeshed, which means it is used as is, or meshed, which means it is stretched to cover a larger area. The purpose of using STSG is to promote healing and improve the appearance of the scar.

Full-thickness skin defects – Full-thickness skin defects involve the loss of both the epidermis and dermis layers of the skin, often exposing underlying tissues such as fat, muscle, or bone. These defects can result from various causes, including trauma, burns, or surgical procedures. The healing process is complex and typically requires medical intervention, as the skin’s natural ability to regenerate is insufficient for full recovery. Over time, the affected area may develop scar tissue, which can vary in appearance and texture. The progression of healing involves stages of inflammation, tissue formation, and remodeling, which can take several months. Scar quality and skin function may be assessed using various parameters, including pliability, pigmentation, and thickness.

Trial ID:

2024-512190-27-00

Protocol code:

TBRU-dS-RAC-PII

NCT ID:

NCT03394612

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of EHSG-KF for Treating Full-Thickness Skin Defects in Adults and Children

What is this study about?

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