Use of Progenitor Biological Bandages in Burn Care (Bru_PBB)

• Status: Not yet recruiting
• Trial end date: 2032-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Skin, as the outermost organ of the human body, serves as a protective layer from microorganisms and external forces, and allows controlling fluid loss among other important functions (sensory, immune and aesthetic functions). When the skin is burned, the extent of the depth can be classified in 1rst, 2nd superficial to deep, 3rd and 4th degree burns, according to the different layers of the skin and tissue that are affected in depth. Severity of a burn can also be characterized by total body surface area (TBSA), location of the burn injury, subject characteristics and age according to the European Practice Guidelines for Burn Care. The actual gold standard treatment for 3rd or deep 2nd degree burn wounds is skin autografting that means transplantation of healthy skin taken from an undamaged donor site on the patient to the wound site, therefore creating a donor site wound (DSW).

The Burn Center of the CHUV has developed Progenitor Biological Bandages (PBB), composed of human skin progenitor cells (produced and stored GMP clinical cell bank with the Hospital accredited Cell Production Center, CPC) seeded on a biodegradable collagen scaffold (Resorba®), to support wound healing of DSW, as well as 2nd degree burn wounds. PBB have been applied at the CHUV under emergency circumstances over the last 20 years in children and adults with a TBSA higher than 10% and 20%, respectively.

These PBB aim to increase the spontaneous healing of 2nd superficial and deep burns to avoid the skin autograft, and therefore prevent the creation of a second wound with the DSW. Furthermore, if skin grafting cannot be avoided, in the case of a 3rd or 2nd degree deep burns that do not close spontaneously, the use of PBB is an advantage for treating DSW in order to accelerate its healing process and therefore use the same donor site for future treatments.

The aim of this study is to demonstrate the efficacy of the PBB treatment of the DSW compared to standard-care treatment (Jelonet®), and therefore verify our hypothesis of higher performance of PBB. We would like also to assess the efficacy of the DSW treatment on short- and long-term periods, as well as to collect observational data on 2nd degree burn wound treated with PBB. Furthermore, another objective of this study is to confirm the safety of the PBB on DSW and 2nd degree burn wounds. The final aim is to implement this specific cell therapy for acute wounds within the CHUV in light of the Transplantation Law changes in 2007.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr Anthony De Buys Roessingh

Criteria

Inclusion Criteria:

• ≤ 2 years old with ≥5% TBSA

• between 3 and 10 years old with ≥10% TBSA

• between 11 and 18 years old with ≥15% TBSA

• ≥ 18 years old with ≥ 20% TBSA

• ≥ 65 years old with ≥ 10% TBSA

• Any age with burns on the face, hands, genitalia or major joints

• Patient with 2nd (superficial to deep) degree burn wounds

• Patient with 3rd degree burns candidate for a skin autograft

• Informed Consent as documented by signature and according to consent in case of emergency situation

• First injury

• Possibility of Follow-up for 5 years after injury

Exclusion Criteria:

• Infected wounds

• Vitally unstable patients

• Known allergy or hypersensitivity to product of equine origin

• Refusal of the study by the participants or relatives