Evaluation of the safety and efficacy of biological dressings for burn care.

Summary description of the study

The main objective of this study is to demonstrate the effectiveness of the treatment of the donor site for grafting (DSW) with PBB compared to standard treatment (Jelonet®), while the secondary objectives are to evaluate the effectiveness of DSW treatment in the short and long term, and to collect observational data on 2nd degree burns treated with PBB as first-line treatment. Additionally, another objective of this study is to confirm the safety of using PBB on DSW wounds and 2nd degree burns. The ultimate goal is to implement this specific cell therapy for acute wounds such as burns within the CHUV and in accordance with the changes to the transplantation law of 2007.

(BASEC)

Intervention under investigation

Patients who will be candidates for autologous skin grafting (with 3rd degree burns or 2nd degree burns that do not close after treatment with PBB) and for whom a donor site wound will be created, will be randomized between a group treated with PBB and a control group treated with standard dressings (Jelonet®), in order to compare the effectiveness of treatment on the healing of the donor site between the two types of dressings. As soon as the donor site wound is created, PBB or Jelonet® will be applied directly to the wound and held in place with standard bandages for a maximum of 15 ± 1 days with dressing changes on day 5 ± 1 and day 10 ± 1. Photographs will be taken at each dressing change and an on-site assessment of healing (% re-epithelialization) will be performed by the operator. If the DSW is not closed by J15 ± 1, Jelonet® will be used to cover the skin until complete closure. If the wound closes after 15 ± 1 days or earlier, the scar will then be treated locally with cream as standard treatment. All patients will be followed up to 5 years according to the long-term evaluation schedule to monitor long-term skin quality. Patients with 2nd degree burns will be treated primarily with PBB which will be applied directly to the 2nd degree burn and held in place with standard bandages for a maximum of 10 to 12 days with dressing changes every 2 to 3 days. Photographs will be taken at each dressing change and an on-site assessment of healing (% re-epithelialization) will be performed by the operator. If the 2nd degree burn is not closed by J10-12, an autologous skin graft will be planned and the treatment of the donor site will be decided by randomization between PBB or Jelonet®. If the wound closes after 10 to 12 days, the scar will then be treated locally with cream as standard treatment. All patients will be followed up to 5 years according to the long-term evaluation schedule to monitor long-term skin quality.

(BASEC)

Disease under investigation

The skin, as the outermost organ of the human body, serves as a protective layer against microorganisms and external forces, and allows for the control of fluid loss among other important functions (sensory, immune, and aesthetic functions). When the skin is burned, the extent of depth can be classified into 1st, 2nd superficial to deep, 3rd and 4th degrees, depending on the different layers of skin and tissue that are affected in depth. The severity of a burn can also be characterized by the total body surface area burned (TBSA), the location of the burn, the characteristics of the subject, and their age. The standard treatment for 3rd or deep 2nd degree burns is autologous skin grafting, which means the transplantation of healthy skin taken from an intact donor site of the patient to the burned site, thereby creating a wound at the donor site. The Burn Center of CHUV has developed biological dressings (PBB), composed of human skin progenitor cells (stored as clinical cell banks produced according to Good Manufacturing Practices and stored by the cell production center (CPC) accredited by CHUV). These cells are ready to use and can be seeded onto a biodegradable collagen support (Resorba®), which is applied directly to the wounds to promote healing of the donor site of the graft, as well as 2nd degree burns. PBB has been applied at CHUV in accordance with emergency medicine over the past 20 years in children and adults with a burned body surface area greater than 10% and 20%, respectively. These PBB aim to improve the spontaneous healing of superficial and deep 2nd degree burns, to avoid autologous skin grafting, and thus prevent the creation of a second wound at the donor site. Furthermore, if autologous skin grafting cannot be avoided, in the case of 3rd or deep 2nd degree burns that do not close spontaneously, the use of PBB is an advantage for the treatment of the donor site wound to accelerate its healing process and be able to reuse the same donor site for subsequent treatments.

(BASEC)

Sponsor

University Hospital CHUV

(BASEC)

Name of the authorising ethics committee (for multicentre studies, only the lead committee)

Ethics Committee Vaud

(BASEC)

Date of authorisation

15.12.2020

(BASEC)

Results of the trial