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A multicentre, intra-patient randomised controlled Phase III study to confirm the efficacy and safety of denovoSkin™, a bilayer engineered collagen-based skin graft composed of autologous fibroblasts and keratinocytes, for the treatment of patients with deep partial and full-thickness burns
EU CTIS ID: 2023-507717-94-00
What this study is testing
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 STSG
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Patients with deep partial or full-thickness thermal burns of >20% TBSA for which excision and SOC (STSG) are clinically indicated according to the applicable ISBI Practice Guidelines for Burn Care
- 2. Patients of either sex aged ≥12 years
- 3. Signed informed consent from the patient and/or legally authorised representative
You likely can't join if
- 1. Burn wound areas solely located on the head and neck (i.e., test and control areas must NOT be located on head/neck)
- 9. Patients unwilling or unable to comply with procedures required in this clinical study protocol
- 10. Pregnant or lactating women
- 2. 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
- 11. 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
- 12. Patient is the Investigator, one of his/her family members, employees, and other dependent persons
See the full eligibility criteria
- 1. Patients with deep partial or full-thickness thermal burns of >20% TBSA for which excision and SOC (STSG) are clinically indicated according to the applicable ISBI Practice Guidelines for Burn Care
- 2. Patients of either sex aged ≥12 years
- 3. Signed informed consent from the patient and/or legally authorised representative
- 1. Burn wound areas solely located on the head and neck (i.e., test and control areas must NOT be located on head/neck)
- 9. Patients unwilling or unable to comply with procedures required in this clinical study protocol
- 10. Pregnant or lactating women
- 2. 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
- 11. 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
- 12. Patient is the Investigator, one of his/her family members, employees, and other dependent persons
- 3. Patients with serologic evidence of active hepatitis B virus infection (i.e., positive for Hepatitis B surface antigen or immunoglobulin M total Hepatitis B core antibody), active hepatitis C infection (hepatitis C virus antibody positive),positive human immunodeficiency virus serology, or positive Treponema pallidum serology
- 4. 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
- 5. Patients with pre-existing coagulation disorders as defined by international normalised ratio outside its normal value, a prothrombin time greater than the upper limit of normal, and fibrinogen less than the lower limit of normal prior to the current hospital admission
- 6. Patients with a history of clinically significant hypersensitivity/allergy to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen and it’s derivatives (e.g. gelatine) and bovine proteins such as Fetal Calf Serum (FBS)
- 7. Previous treatment with denovoSkin™
- 8. Patients treated <60 days with monoclonal antibodies, and <30 days with any other IMP or skin-cell related therapy, prior to screening visit for the denovoSkin™ study
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.