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Study on the Safety and Effectiveness of EHSG-KF for Treating Deep Dermal and Full Thickness Burns in Children

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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 children. The treatment being tested is a new type of skin graft called EHSG-KF, which is a special skin substitute made from a combination of the child’s own skin cells, specifically keratinocytes and fibroblasts. These cells are used to create a bilayer engineered collagen hydrogel-based skin graft, which is applied to the burn area to help it heal.

The purpose of the study is to evaluate how safe and effective this new skin graft is compared to the traditional method of using the child’s own skin, known as autologous split-thickness skin grafts (STSG). The study will involve children who have burns that require surgical treatment. During the study, the new skin graft will be applied to the burn area, and the healing process will be monitored over time. The study will look at how well the burn area heals and how the new skin graft compares to the traditional method in terms of covering the burn area and the quality of the healed skin.

Participants in the study will be observed for a period of time after the grafting procedure to assess the healing process. This includes checking the burn area at different intervals, such as four weeks and three months after the grafting, to see how well the skin has healed and to ensure there are no signs of infection. The study will also evaluate the quality of the scar one year after the procedure. The goal is to determine if the new skin graft can provide a better healing outcome for children with severe burns.

1 joining the study

Upon joining the study, the patient or their guardian will have signed an informed consent form. This confirms understanding and agreement to participate in the trial.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying that the patient is under 12 years of age and has deep partial thickness or full-thickness burns requiring surgical wound coverage.

3 treatment with EHSG-KF

The patient will receive treatment with a new skin graft product called EHSG-KF. This is a special type of skin graft made from the patient’s own skin cells, applied to the burn area.

4 post-grafting visits

Several follow-up visits will be scheduled to monitor the healing process and evaluate the effectiveness of the treatment.

Visit 4 will occur 6-10 days after grafting to check for any signs of infection.

Visit 5 will take place 21 ± 2 days post-grafting to continue monitoring for infection.

5 efficacy evaluation

At visit 6, which is 28 ± 3 days after grafting, the effectiveness of the EHSG-KF treatment will be evaluated by comparing the treated area to a control site.

6 further healing assessment

Visit 8, scheduled 90 ± 5 days post-grafting, will assess the percentage of the burn area that has healed.

7 long-term follow-up

A long-term follow-up will occur at visit 10, one year ± 30 days after grafting. This will include an assessment of scar quality and elasticity using specialized tools.

8 reporting adverse events

Throughout the study, any adverse events or unexpected reactions will be documented and assessed from visit 2 onwards.

Who Can Join the Study?

  • Children must be under 12 years old.
  • Children must have deep partial thickness or full-thickness burns that need surgical wound coverage.
    • Deep partial thickness burns are burns that go deeper into the skin but not all the way through.
    • Full-thickness burns are 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.
    • This does not include the head and neck area for patients in The Netherlands.
  • A signed informed consent is required from the patient or their parents/legal representative.
    • Informed consent means that the patient or their guardian understands the study and agrees to participate.

Who Cannot Join the Study?

  • Patients who have burns that are not partial deep dermal or full thickness. Partial deep dermal burns are burns that go through part of the skin layers, while full thickness burns go through all the skin layers.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have other medical conditions that might interfere with the study.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have allergies or reactions to the study treatments.
  • Patients who are unable to provide consent or do not have a legal guardian to provide consent on their behalf.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
ASST Fatebenefratelli Sacco Milan Italy
Azienda Ospedaliera Santobono Pausilipon Naples Italy
Rode Kruis Ziekenhuis B.V. Beverwijk The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
01.10.2017
The Netherlands The Netherlands
Not recruiting
01.10.2017

Trial locations

Investigated drugs:

EHSG-KF is a special type of skin treatment used in this clinical trial. It is a bio-engineered skin substitute, which means it is created in a lab using the patient’s own skin cells. This treatment is designed to help heal deep skin burns by covering the damaged area with new skin. The goal is to see if this method is safe and effective for children with serious burns, compared to the traditional method of using skin grafts from another part of the patient’s body.

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 one part of the patient’s body and used to cover the burned area. This helps the burn heal by providing a protective layer and promoting new skin growth. The trial is comparing this method to the new EHSG-KF treatment to see which one works better for healing burns in children.

Investigated diseases:

Partial Deep Dermal and Full Thickness Burns – Partial deep dermal burns affect the deeper layers of the skin, damaging both the outer and inner layers, but not completely destroying them. These burns can cause severe pain and may result in blisters and swelling. Over time, the skin may appear red or white and can become dry and leathery. Full thickness burns, on the other hand, destroy all layers of the skin, including the underlying tissue. These burns may not be painful initially due to nerve damage, and the skin may appear charred or white. As they progress, both types of burns can lead to significant scarring and require a long healing process.

Trial ID:
2024-512189-33-00
Protocol code:
TBRU-dS-BC-PIIb
NCT ID:
NCT03229564
Trial Phase:
Therapeutic exploratory (Phase II)

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