Phase III Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents

August 6, 2026 updated by: CUTISS AG

A Multicentre, Intra-patient Randomised Controlled Phase III Study to Confirm the Efficacy and Safety of denovoSkin™, a Bilayer Engineered Collagen-based Skin Graft Composed of Autologous Fibroblasts and Keratinocytes, for the Treatment of Patients With Deep Partial and Full-thickness Burns

This multicentre phase III clinical trial will target adults and adolescents of 12 years and older with severe burns to confirm the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in patients with deep partial and full-thickness burns as compared to split-thickness skin.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Liège, Belgium, B-4000
        • Recruiting
        • CHU de Liège Département de pharmacie hospitalière - Secteur Essais cliniques
        • Contact:
  • France
      • Lyon, France, 69003
        • Recruiting
        • Hopital Edouard Herriot Centre des Brûlés de Lyon
        • Contact:
      • Marseille, France, 13005
        • Recruiting
        • Pharmacie Hôpital Conception
        • Contact:
      • Montpellier, France, 34295
        • Recruiting
        • Centre Hospitalier Universitaire de Montpellier
        • Contact:
  • Germany
      • Berlin, Germany, 12683
        • Recruiting
        • BG Klinikum Unfallkrankenhaus Berlin
        • Contact:
      • Halle, Germany, 06112
        • Recruiting
        • Bg Klinikum Bergmannstrost Halle
        • Contact:
      • Hanover, Germany, 30625
      • Murnau am Staffelsee, Germany, 82418
  • Italy
      • Naples, Italy, 80129
      • Naples, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli
        • Contact:
      • Padova, Italy, 35128
  • Netherlands
      • Beverwijk, Netherlands, 1942
        • Recruiting
        • Rode Kruis Ziekenhuis
        • Contact:
      • Rotterdam, Netherlands, 3079 DZ
        • Recruiting
        • Maasstad Hospital Dep. Burn Wound Centre
        • Contact:
  • Poland
      • Łęczna, Poland, 21-010
        • Recruiting
        • Samodzielny Zakład Opieki Zdrowotnej z siedzibą w Łęcznej
        • Contact:
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Recruiting
        • Unidade de Queimados do CHUC
        • Contact:
  • Spain
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz Edificio Traumatología
        • Contact:
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitatrio y Politécnico La Fe
        • Contact:
  • Switzerland
      • Zurich, Switzerland, 8091
        • Recruiting
        • Universtitätsspital Zürich
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with deep partial or full-thickness thermal burns of ≥20% total body surface area (TBSA) for which excision and standard of care (SOC) (STSG) are clinically indicated
  • Patients of either sex aged ≥12 years
  • Signed informed consent from the patient and/or legally authorised representative

Exclusion Criteria:

  • Burn wound areas solely located on the head and neck (i.e., test and control areas must NOT be located on head/neck)
  • Patients eligible to have all areas autografted in a single surgery or significantly earlier than the end of the manufacturing period of denovoSkin™, for whom the application of denovoSkin™ would delay the standard of care therapies
  • Patients with serologic evidence of active hepatitis B virus (HBV) infection (i.e., positive for Hepatitis B surface antigen [HbsAg] or immunoglobulin M total hepatitis B core antibody [anti-HBc]), active hepatitis C infection (hepatitis C virus [HCV] antibody positive), positive human immunodeficiency virus (HIV) serology, or positive Treponema pallidum serology assessed as per local standard of care; cured hepatitis C (defined as documented treatment and negative viral load) is not an exclusion
  • Patients with known underlying or concomitant medical conditions that, in the opinion of the Investigator, has the potential to significantly delay wound healing, e.g., glycated haemoglobin (HbA1c) ≥53 mmol/mol and/or systemic skin and connective tissue diseases
  • Patients with pre-existing coagulation disorders as defined by international normalised ratio (INR) outside its normal value, a prothrombin time (PT) greater than the upper limit of normal, and fibrinogen less than the lower limit of normal prior to the current hospital admission
  • Patients with a history of clinically significant hypersensitivity to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen and it's derivatives (e.g. gelatine)
  • Previous treatment with denovoSkin™
  • Participation in any clinical interventional study within 60 days prior to the first IMP administration in case of monoclonal antibodies and <30 days for all other IMPs
  • Patients unwilling or unable to comply with procedures required in this clinical study protocol
  • Pregnant or lactating women
  • Women of child-bearing potential not using highly effective method(s) of birth control (i.e., with low failure rate <1% per year) throughout the study and/or unwilling to be tested for pregnancy. A negative serum beta-human chorionic gonadotropin (β-hCG) test is required on the day of grafting
  • Patient is the Investigator, one of his/her family members, employees, and other dependent persons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Option 1
Location A is the experimental area and Location B is the control area
Biological: denovoSkin(TM)
Transplantation of autologous dermo-epidermal skin substitute denovoSkin(TM) to the experimental area
Other Names:
  • EHSG-KF
Other: STSG
Transplantation of autologous split-thickness skin to the control area
Other Names:
  • split-thickness skin graft
Other: Option 2
Location A is the control area and Location B is the experimental area
Biological: denovoSkin(TM)
Transplantation of autologous dermo-epidermal skin substitute denovoSkin(TM) to the experimental area
Other Names:
  • EHSG-KF
Other: STSG
Transplantation of autologous split-thickness skin to the control area
Other Names:
  • split-thickness skin graft

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
A composite endpoint whereby success is defined by meeting both of the following criteria: - Wound closure - Scar quality (POSAS v2.0)
Time Frame: 6 months post grafting

A composite endpoint whereby success is defined by meeting both of the following criteria:

  • Wound closure
  • Scar quality (POSAS v2.0)
6 months post grafting

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ratio of covered surface area to biopsy site/donor site surface area at 4 weeks post-grafting
Time Frame: 4 weeks
Ratio of covered surface area to biopsy site/donor site surface area at 4 weeks post-grafting
4 weeks
Assessment of scar contracture
Time Frame: 6 months post grafting
Assessment of scar contracture
6 months post grafting
Epithelialisation percentage at 3 months and 6 months post-grafting
Time Frame: 3 months and 6 months post-grafting
Epithelialisation percentage at 3 months and 6 months post-grafting
3 months and 6 months post-grafting
Graft take at 14 and 21 days post-grafting
Time Frame: 14 and 21 days post-grafting
Graft take at 14 and 21 days post-grafting
14 and 21 days post-grafting
Assessment of the donor sites
Time Frame: 4 and 10 weeks, and 3, 6, 12, and 24 months post-grafting
Assessment of the donor sites
4 and 10 weeks, and 3, 6, 12, and 24 months post-grafting
Assessment of the grafted burn wounds areas
Time Frame: 4 and 10 weeks and 3, 6, 12, and 24 months post-grafting
Assessment of the grafted burn wounds areas
4 and 10 weeks and 3, 6, 12, and 24 months post-grafting
Assessment of scar contracture
Time Frame: 12 and 24 months post-grafting
Assessment of scar contracture
12 and 24 months post-grafting

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of safety and tolerability using the National Cancer Institute-CTCAE v5.0 throughout the study: - Assessment of the incidence of treatment-emergent adverse events (TEAEs), total AEs, and serious adverse events (SAEs)
Time Frame: 24 months

Assessment of safety and tolerability using the National Cancer Institute-CTCAE v5.0 throughout the study:

- Assessment of the incidence of treatment-emergent adverse events (TEAEs), total AEs, and serious adverse events (SAEs)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CUTISS AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
RCTs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • dS-BA-PIII

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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