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Study on the Effectiveness of EHSG-KF Skin Graft for Patients with Deep Partial and Full-Thickness Burns

Verified siteInvestigationalNo placebo
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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 the treatment of deep partial and full-thickness burns. The treatment being tested is called denovoSkin™, which is a special type of skin graft. This skin graft is made from a bilayer engineered collagen hydrogel that includes 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 confirm how effective and safe this new treatment is for helping wounds heal and reducing scarring compared to the standard skin grafting method.

During the study, patients will receive the denovoSkin™ treatment, and their progress will be monitored over time. The study will look at how well the wounds close and how much scarring occurs after the treatment. The treatment involves implanting the skin graft onto the burn area, and the healing process will be observed at various intervals, such as 10 weeks, 3 months, and 6 months after the grafting. The study will also assess the quality of the skin and any potential infections at the grafted sites.

The trial aims to provide valuable information on whether denovoSkin™ can be a better option for patients with severe burns, offering improved healing and less scarring. This research could lead to advancements in burn treatment, providing new hope for those affected by serious burn injuries. The study is expected to continue until 2028, allowing for comprehensive data collection and analysis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Eligibility is determined based on specific criteria, including having deep partial or full-thickness burns covering at least 20% of the total body surface area and being at least 12 years old.

    Informed consent is required from the patient or a legally authorized representative.

  2. Step 2

    Treatment preparation

    The treatment involves a skin graft called denovoSkin™, which is a bilayer engineered collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts.

    The graft is prepared for implantation.

  3. Step 3

    Grafting procedure

    The denovoSkin™ graft is implanted onto the burn areas.

    The goal is to achieve wound closure and reduce scarring.

  4. Step 4

    Post-grafting evaluation

    Wound closure is assessed at 10 weeks post-grafting, aiming for at least 95% epithelialization.

    The overall opinion of the scar is evaluated at 6 months using the POSAS v2.0 questionnaire.

  5. Step 5

    Follow-up assessments

    The ratio of covered surface area to biopsy site is evaluated at 4 weeks post-grafting.

    Scar contracture is assessed at 6 months, 12 months, and 24 months post-grafting.

    Epithelialization percentage is checked at 3 months and 6 months post-grafting.

    Graft take is evaluated at 14 and 21 days post-grafting.

  6. Step 6

    Long-term monitoring

    Donor sites and grafted burn wound areas are assessed for infection and scar quality at 4 weeks, 10 weeks, 3 months, 6 months, 12 months, and 24 months post-grafting.

    The study is estimated to conclude by January 31, 2028.

Who can join the trial?

3 criteria

  • Patients must have **deep partial or full-thickness thermal burns** covering at least 20% of their body. These are serious burns that affect deeper layers of the skin.
  • Patients must be at least **12 years old**. This means they can be 12 years or older.
  • Patients must provide a **signed informed consent**. This is a document that shows they understand the study and agree to participate. If the patient is unable to sign, a legally authorized representative can sign on their behalf.

Who cannot join the trial?

5 criteria

  • Patients with burns that are not deep partial or full-thickness. These terms refer to the severity of the burn. A deep partial-thickness burn affects deeper layers of the skin, while a full-thickness burn goes through all layers of the skin.
  • Patients who are not within the specified age range for the study. The study includes certain age groups, so if you are outside these groups, you cannot participate.
  • Patients who do not belong to the specified clinical trial groups. The study is looking for specific types of participants, so if you do not fit these groups, you cannot join.
  • Patients who are not male or female, as the study includes both genders.
  • Patients who are not considered part of a vulnerable population. This term refers to groups of people who might need special protection or consideration in research, such as children or the elderly.
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Investigated drugs

  • denovoSkin™

    is a specially engineered skin graft made from two layers of collagen. It includes the patient's own skin cells, specifically fibroblasts and keratinocytes. This graft is used to help heal deep partial and full-thickness burns by promoting wound closure and reducing scarring.

  • STSG

    , or Split-Thickness Skin Graft, is a traditional method used to treat burns. It involves taking a thin layer of skin from an unburned area of the body and transplanting it to the burn site to aid in healing.

What is already known about the treatment

DenovoSkin – DenovoSkin is a bilayer engineered collagen-based skin graft designed for the treatment of deep partial and full-thickness burns. It is applied directly to the wound site, where it integrates with the patient's skin to promote healing. Currently, it is in Phase III clinical trials, aiming to confirm its efficacy and safety. The main therapeutic indication is to achieve wound closure and reduce scarring in burn patients. At the molecular level, it works by utilizing autologous fibroblasts and keratinocytes to regenerate skin tissue. DenovoSkin falls under the pharmacological classification of tissue-engineered products.

Investigated diseases

Deep partial and full-thickness burns – These burns involve damage to multiple layers of the skin, with deep partial-thickness burns affecting the dermis and full-thickness burns extending through the entire dermis and potentially into underlying tissues. Initially, the skin may appear red, blistered, or charred, and there is often significant pain or numbness due to nerve damage. As the burn progresses, the affected area may become dry and leathery, and healing can be slow, often requiring medical intervention to prevent infection and promote tissue regeneration. Scar formation is common, and the extent of scarring can vary based on the depth and size of the burn. Over time, the skin may contract, leading to reduced mobility or function in the affected area.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507717-94-00Protocol codedS-BA-PIIIEstimated enrolment108 patientsSponsorCutiss AG

sourced from the EU Clinical Trials Register and site verification

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