Using a skin substitute to treat severe burns in adults and adolescents
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
PHASE3 · CUTISS AG · NCT06745557
This study is testing a new skin treatment called denovoSkin™ to see if it helps adults and teens with severe burns heal better and have less scarring compared to the usual skin grafts.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | CUTISS AG (industry) |
| Locations | 1 site (Beverwijk) |
| Trial ID | NCT06745557 on ClinicalTrials.gov |
What this trial studies
This multicenter phase III clinical trial aims to evaluate the efficacy of denovoSkin™, an autologous dermo-epidermal skin substitute, in treating severe burns in patients aged 12 years and older. The study will compare the effectiveness of denovoSkin™ in achieving wound closure and minimizing scarring against the standard treatment of split-thickness skin grafts (STSG). Participants will include those with deep partial and full-thickness burns covering at least 20% of their total body surface area. The trial seeks to confirm the functionality of this innovative treatment approach in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults and adolescents aged 12 years and older with deep partial or full-thickness burns covering at least 20% of their total body surface area.
Not a fit: Patients with burn wounds located solely on the head and neck or those who can receive standard care without delay may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve wound healing and reduce scarring for patients with severe burns.
How similar studies have performed: Other studies have shown promise with similar skin substitute approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beverwijk
- Rode Kruis Ziekenhuis — Beverwijk, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Daniela Marino
- Email: clinicaltrials@cutiss.swiss
- Phone: +41 44 244 36 60
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Burns, Skin, Scars, Wound healing, Dermis, Epidermis, Thermal burns