Study on EHSG-KF for Treating Partial Deep Dermal and Full Thickness Burns in Adults and Adolescents

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What is this study about?

This clinical trial is focused on studying the treatment of partial deep dermal and full-thickness burns in adults and adolescents. The treatment being tested is a new type of skin graft called EHSG-KF, which is a special skin substitute made from a bilayer engineered collagen hydrogel. This hydrogel is composed of the patient’s own skin cells, specifically keratinocytes and fibroblasts. These are types of cells that play a crucial role in skin repair and regeneration.

The purpose of the study is to evaluate the safety and effectiveness of the EHSG-KF treatment compared to the traditional method of using autologous split-thickness skin grafts (STSG). Participants in the study will receive both the new EHSG-KF treatment and the standard STSG treatment, allowing researchers to compare the results. The study will monitor how well the skin heals over time, looking at factors such as the area of skin covered by the graft and the quality of the scar that forms.

Throughout the study, participants will have regular check-ups to assess the healing process and any potential side effects. These check-ups will include evaluations of the skin’s appearance and elasticity, as well as monitoring for any signs of infection. The study aims to provide valuable information on whether the EHSG-KF treatment can offer a better alternative for patients with severe burns, potentially improving healing outcomes and reducing scarring.

1 enrollment and consent

Upon joining the study, the patient will provide signed informed consent, either personally or through a legally authorized representative. 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 age (12 years or older) and the presence of deep partial thickness or full-thickness burns requiring surgical wound coverage.

3 treatment allocation

The patient will be randomly assigned to receive either the new skin graft product, EHSG-KF, or the standard treatment, which is a split-thickness skin graft (STSG).

4 grafting procedure

The assigned treatment will be applied to the burn area. The EHSG-KF is a hydrogel-based skin graft composed of the patient’s own skin cells, applied directly to the skin.

5 follow-up visit 1

6 to 10 days after the grafting procedure, the patient will attend a follow-up visit to check for any signs of infection and to assess the initial healing progress.

6 follow-up visit 2

21 days after the grafting procedure, another follow-up visit will occur to continue monitoring for infection and to evaluate the healing of the grafted area.

7 efficacy evaluation

28 days after the grafting, the patient will have an evaluation to measure the ratio of the covered surface area to the biopsy or donor site surface area. This helps assess the effectiveness of the treatment.

8 follow-up visit 3

90 days after the grafting, the patient will attend another follow-up visit to assess the percentage of epithelialization, which indicates how well the skin has healed.

9 final assessment

One year after the grafting, a final assessment will be conducted. This includes evaluating the quality of the scar using specific tools to measure elasticity and overall appearance.

Who Can Join the Study?

Must be 12 years of age or older.
Have deep partial thickness or full-thickness burns that need surgical wound coverage.
- Deep partial thickness burns: Burns that go through the top layer of skin and into the second layer.
- Full-thickness burns: Burns that go through all layers of the skin.
It is expected that at least 90 square centimeters of the wound will still be open 4 weeks after the burn, even with standard treatment.
- 90 square centimeters: About the size of a small postcard.
Must provide signed informed consent.
- Informed consent: Agreement to participate after understanding the study details.

Who Cannot Join the Study?

Patients with infections at the burn site. 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 uncontrolled diabetes. This means their blood sugar levels are not stable.
Patients with severe heart, liver, or kidney problems.
Patients who have had another experimental treatment in the last 30 days. An experimental treatment is a new treatment that is still being tested.
Patients who are allergic to any of the study materials. An allergy is when the body reacts badly to something.
Patients with mental health conditions that might affect their ability to follow the study instructions.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Rode Kruis Ziekenhuis B.V.	Beverwijk	The Netherlands
Maasstad Ziekenhuis Stichting	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.10.2017

Trial locations

Investigated drugs:

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

EHSG-KF is a special type of skin treatment used in this clinical trial. It is a bio-engineered skin substitute made from the patient’s own skin cells. This means that the skin cells are taken from the patient, grown and processed in a lab, and then used to create a new layer of skin. This new skin is then applied to the burn area to help it heal. The goal of using EHSG-KF is to see if it can cover and heal burn wounds effectively and safely, compared to traditional skin grafts.

Autologous Split-Thickness Skin Grafts (STSG) are a traditional method used to treat burns. In this process, a thin layer of skin is taken from another part of the patient’s body, usually an area that is not burned. This skin is then placed over the burn wound to help it heal. The trial is comparing this traditional method to the new EHSG-KF treatment to see which one works better for healing burns.

Investigated diseases:

Thermal burn

Partial Deep Dermal and Full Thickness Burns – Partial deep dermal burns affect the deeper layers of the skin, damaging both the epidermis and parts of the dermis. These burns can cause severe pain, redness, and blistering, and they may appear white or charred. Full thickness burns, also known as third-degree burns, extend through the entire dermis and affect deeper tissues. These burns can destroy nerve endings, leading to numbness in the affected area. The skin may appear stiff, leathery, or waxy, and the color can range from white to black. Both types of burns can result in significant scarring and require a long healing process.

Trial ID:

2024-512188-29-00

Protocol code:

TBRU-dS-BA-PIIb

NCT ID:

NCT03227146

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on EHSG-KF for Treating Partial Deep Dermal and Full Thickness Burns in Adults and Adolescents

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