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

NCT ID: NCT06745557

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-13
• Study Completion Date: 2028-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Option 1

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

Group Type: OTHER

denovoSkin(TM)

Intervention Type: BIOLOGICAL

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

STSG

Intervention Type: OTHER

Transplantation of autologous split-thickness skin to the control area

Option 2

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

Group Type: OTHER

denovoSkin(TM)

Intervention Type: BIOLOGICAL

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

STSG

Intervention Type: OTHER

Transplantation of autologous split-thickness skin to the control area

Interventions

denovoSkin(TM)

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

Intervention Type: BIOLOGICAL

STSG

Transplantation of autologous split-thickness skin to the control area

Intervention Type: OTHER

Other Intervention Names

EHSG-KF; split-thickness skin graft

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RCTs

INDUSTRY

Sponsor Role: collaborator

CUTISS AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rode Kruis Ziekenhuis

Beverwijk, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Daniela Marino

Role: CONTACT

clinicaltrials@cutiss.swiss

+41 44 244 36 60

Facility Contacts

Prof. E. Middelkoop

Role: primary

emiddelkoop@burns.nl

+31 251 265 555

Other Identifiers

dS-BA-PIII

Identifier Type: -

Identifier Source: org_study_id