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

Cutiss

Status and phase: Enrolling; Phase 3

Conditions: Burns

Treatments: Biological: denovoSkin(TM); Other: STSG

Study type: Interventional

Funder types: Industry

Identifiers

NCT06745557

dS-BA-PIII

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

Option 1

Other group

Description:

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

Treatment:

Other: STSG

Biological: denovoSkin(TM)

Option 2

Other group

Description:

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

Treatment:

Other: STSG

Biological: denovoSkin(TM)