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: 1 country
• Sites: 1

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

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

STSG OTHER

Transplantation of autologous split-thickness skin to the control area

Also known as: split-thickness skin graft

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 (1)

Rode Kruis Ziekenhuis

Beverwijk, 1942, Netherlands

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): December 31, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)