A study to investigate whether denovoSkin™, a collagen-based skin graft* with autologous skin cells, can improve the treatment of patients with burns requiring a skin graft compared to an autologous skin graft. *Collagen is a group of proteins primarily responsible for fiber formation in the body.

Zusammenfassung der Studie

The main objective of this clinical study is to find out whether denovoSkin™ can be successfully used to cover burns and how the scar looks when a wound is treated with denovoSkin™. The size of the skin area that needs to be taken to produce denovoSkin™ (equivalent to the size of a postage stamp) will be compared to the size of the skin area that needs to be taken to cover a similar wound area with the standard method (split-thickness skin graft) (equivalent to one-third of the area to be treated). Additionally, the appearance and texture of the scars at the sites treated with denovoSkin™ or with the standard method will be compared. Further objectives of the clinical study are to find out whether denovoSkin™ is safe and well-tolerated by patients, whether there are infections after application, and how long patients need to stay in the hospital. Numerous hospitals in Switzerland and in various countries of the European Union will participate. When a patient is admitted to a hospital participating in this clinical study, the hospital team will talk with the patient or their family/representative, explain the clinical study, and ask if they are interested in participating. If the patient or their legal representative agrees to participate, the patient will be enrolled in the clinical study, and treatment will then proceed according to the study protocol provided for this study. This means that each patient will have a total of 11 study visits over a period of 2 years.

(BASEC)

Untersuchte Intervention

At the first study visit (Visit 1), a member of the study team will explain all the details of the study at the hospital, and the patient or their legal representative will have the opportunity to ask questions. If they decide to participate, the patients/legal representatives will sign a consent form to indicate their agreement to participate. A small amount of blood will then be drawn for laboratory analysis. During all study visits, photos of the examination areas will be taken.

At the second visit, a small piece of very thin skin the size of a postage stamp will be taken. This is referred to as a skin biopsy. It will then be sent to the laboratory, where denovoSkin™ will be produced from this skin biopsy. Once denovoSkin™ is ready, it will be sent to the hospital for transplantation.

At study visit 3: After receiving denovoSkin™ at the hospital, it will be transplanted onto the patient's wound (test area) during surgery, while the comparison area (control area) will be treated with the current standard method.

From study visit 4 to 11: About 2 weeks after the surgery, the dressings will be changed for the first time. In the following weeks and up to 24 months, the condition of the transplanted skin will be monitored to see if it heals properly, if it is soft and looks good. For this purpose, photos will be taken. Additionally, two small instruments will be used to measure the elasticity and color of the skin. Along with a member of the hospital study team, the patient will also fill out some questionnaires to assess the quality of their scars.

(BASEC)

Untersuchte Krankheit(en)

deep second- and third-degree burns

(BASEC)

Sponsor

CUTISS AG

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Zürich

(BASEC)

Datum der Bewilligung durch die Ethikkommission

04.02.2025

(BASEC)

Ergebnisse der Studie