Burns
Conditions
Keywords
Burns, Skin, Scars, Wound healing, Dermis, Epidermis, Thermal burns
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.
Interventions
BIOLOGICALdenovoSkin(TM)
Transplantation of autologous dermo-epidermal skin substitute denovoSkin(TM) to the experimental area
OTHERSTSG
Transplantation of autologous split-thickness skin to the control area
Sponsors
CUTISS AG
RCTs
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intra-patient randomisation
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | A composite endpoint whereby success is defined by meeting both of the following criteria: * Wound closure * Scar quality (POSAS v2.0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of covered surface area to biopsy site/donor site surface area at 4 weeks post-grafting | 4 weeks | Ratio of covered surface area to biopsy site/donor site surface area at 4 weeks post-grafting |
| Assessment of scar contracture | 6 months post grafting | Assessment of scar contracture |
| Epithelialisation percentage at 3 months and 6 months post-grafting | 3 months and 6 months post-grafting | Epithelialisation percentage at 3 months and 6 months post-grafting |
| Graft take at 14 and 21 days post-grafting | 14 and 21 days post-grafting | Graft take at 14 and 21 days post-grafting |
| Assessment of the donor sites | 4 and 10 weeks, and 3, 6, 12, and 24 months post-grafting | Assessment of the donor sites |
| Assessment of the grafted burn wounds areas | 4 and 10 weeks and 3, 6, 12, and 24 months post-grafting | Assessment of the grafted burn wounds areas |
Countries
Belgium, France, Germany, Italy, Netherlands, Poland, Portugal, Spain, Switzerland
Contacts
CONTACTDaniela Marino
Outcome results
None listed