Azienda Ospedaliera Santobono Pausilipon
Naples, Italy
Not recruitingSkin graft
Study on the Safety and Effectiveness of EHSG-KF for Treating Full-Thickness Skin Defects in Adults and Children
Verified siteInvestigational
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What is this trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
12 criteria
- 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 trial?
9 criteria
- 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.
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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Verified Verified Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, ItalyVerified Azienda Ospedaliera di Padova
Padua, Italy
Trial locations
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Investigated drugs
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.
What is already known about the treatment
EHSG-KF – This medication is an autologous bio-engineered dermo-epidermal skin substitute, which means it is a skin graft created from the patient's own cells. It is applied directly to the skin to treat full-thickness skin defects in both adults and children. Currently, it is being studied in clinical trials to assess its safety and effectiveness compared to traditional skin grafts. The main therapeutic use is to improve healing and scar quality in patients with significant skin damage. At the molecular level, it works by integrating with the patient's skin to promote natural healing and regeneration. It falls under the pharmacological classification of tissue-engineered products.
Investigated diseases
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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512190-27-00Protocol codeTBRU-dS-RAC-PIIEstimated enrolment20 patientsSponsorCutiss AG
sourced from the EU Clinical Trials Register and site verification
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