Using a skin substitute to treat severe burns in adults and adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU de Liège Département de pharmacie hospitalière - Secteur Essais cliniques
  Liège, Belgium Recruiting
• Hopital Edouard Herriot Centre des Brûlés de Lyon
  Lyon, France Recruiting
• Pharmacie Hôpital Conception
  Marseille, France Recruiting
• Centre Hospitalier Universitaire de Montpellier
  Montpellier, France Recruiting
• BG Klinikum Unfallkrankenhaus Berlin
  Berlin, Germany Recruiting
• BG Klinikum Bergmannstrost Halle
  Halle, Germany Recruiting

Study contacts

• Study coordinator: Daniela Marino
• Email: clinicaltrials@cutiss.swiss
• Phone: +41 44 244 36 60

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Presepsin blood test for early sepsis detection in severe burn patients

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  Recruiting Hangang Sacred Heart Hospital · Seoul, Seoul · NCT07060560

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.