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

NCT06745557 | Recruiting Phase 3 DMC

• 1 other identifier: dS-BA-PIII
• Study Type: interventional
• Target: 70
• Locations: 9 countries
• Sites: 19

Brief Summary

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.

Conditions

Burns

Keywords

Burns; Skin; Scars; Wound healing; Dermis; Epidermis; Thermal burns

Outcome Measures

Primary Outcomes (1)

• A composite endpoint whereby success is defined by meeting both of the following criteria: - Wound closure - Scar quality (POSAS v2.0)

  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 Outcomes (7)

• Ratio of covered surface area to biopsy site/donor site surface area at 4 weeks post-grafting

  4 weeks

• Assessment of scar contracture

  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

  14 and 21 days post-grafting

• Assessment of the donor sites

  4 and 10 weeks, and 3, 6, 12, and 24 months post-grafting

Other Outcomes (1)

• 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

Study Arms (2)

Option 1

OTHER

Location A is the experimental area and Location B is the control area

Biological: denovoSkin(TM); Other: STSG

Option 2

OTHER

Location A is the control area and Location B is the experimental area

Biological: denovoSkin(TM); Other: STSG

Interventions

STSG OTHER

Transplantation of autologous split-thickness skin to the control area

Also known as: split-thickness skin graft

Option 1; Option 2

denovoSkin(TM) BIOLOGICAL

Transplantation of autologous dermo-epidermal skin substitute denovoSkin(TM) to the experimental area

Also known as: EHSG-KF

Option 1; Option 2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• CUTISS AG: lead
• RCTs: collaborator

Study Sites (19)

CHU de Liège Département de pharmacie hospitalière - Secteur Essais cliniques

Liège, B-4000, Belgium

RECRUITING

Hopital Edouard Herriot Centre des Brûlés de Lyon

Lyon, 69003, France

RECRUITING

Pharmacie Hôpital Conception

Marseille, 13005, France

RECRUITING

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

RECRUITING

BG Klinikum Unfallkrankenhaus Berlin

Berlin, 12683, Germany

RECRUITING

BG Klinikum Bergmannstrost Halle

Halle, 06112, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

NOT YET RECRUITING

BG-Unfallklinik Murnau

Murnau am Staffelsee, 82418, Germany

RECRUITING

Santobono-Pausilipon

Naples, 80129, Italy

RECRUITING

Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli

Naples, 80131, Italy

RECRUITING

AOU Padova

Padova, 35128, Italy

NOT YET RECRUITING

Rode Kruis Ziekenhuis

Beverwijk, 1942, Netherlands

RECRUITING

Maasstad Hospital Dep. Burn Wound Centre

Rotterdam, 3079 DZ, Netherlands

RECRUITING

Samodzielny Zakład Opieki Zdrowotnej z siedzibą w Łęcznej

Łęczna, 21-010, Poland

RECRUITING

Unidade de Queimados do CHUC

Coimbra, 3000-075, Portugal

RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario La Paz Edificio Traumatología

Madrid, 28046, Spain

RECRUITING

Hospital Universitatrio y Politécnico La Fe

Valencia, 46026, Spain

RECRUITING

Universtitätsspital Zürich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Burns; Cicatrix

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Daniela Marino

CONTACT

+41 44 244 36 60; clinicaltrials@cutiss.swiss

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intra-patient randomisation

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 20, 2024
• Study Start: December 13, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2029
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); IT (3); PL (1); BE (1); FR (3); DE (4); ES (3); CH (1); PT (1)