Use of Progenitor Biological Bandages in Burn Care (Bru_PBB)

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. The investigators 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.

Conditions

• Burn Injury

Interventions

DRUG

Progenitor Biological Bandages

The patients candidates for a skin autograft and a consequent Donor Site Wound (DSW) creation with a dermatome will be randomized between 2 treatment arms. As soon as DSW is created and according to randomization results, PBB will be placed on the wound and maintained in place with the help of classical bandages for a maximum of 15 ± 1 days with dressing's changes at Day 5 ± 1 and Day 10 ± 1. Old PBB will be replaced by new ones according to the local procedure. Pictures will be taken at each change and on-site evaluation of the wound healing (% of re-epithelialization) will be done by the surgeon. If the DSW is not closed at D15 ± 1, Jelonet® will be used to cover the skin until complete skin closure. If the wound is closed after 15 ± 1 days or before, the scar will then be topically treated with cream as standard treatment. All patients will be followed until 5 years according to the long-term evaluation calendar to monitor long-term skin quality.

DEVICE

Jelonet

The patients candidates for a skin autograft and a consequent Donor Site Wound (DSW) creation with a dermatome will be randomized between 2 treatment arms. As soon as DSW is created and according to randomization results, Jelonet, as standard bandages, will be placed on the wound and maintained in place with the help of classical bandages for a maximum of 15 ± 1 days with dressing's changes at Day 5 ± 1 and Day 10 ± 1. Pictures will be taken at each change and on-site evaluation of the wound healing (% of re-epithelialization) will be done by the surgeon. If the DSW is not closed at D15 ± 1, Jelonet® will be used to cover the skin until complete skin closure. If the wound is closed after 15 ± 1 days or before, the scar will then be topically treated with cream as standard treatment. All patients will be followed until 5 years according to the long-term evaluation calendar to monitor long-term skin quality.

Sponsors & Collaborators

• Dr Anthony De Buys Roessingh

  lead OTHER

Principal Investigators

• Anthony De Buys Roessingh · Lausanne Burn Center, Lausanne University Hospital CHUV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2025-07-17

Completion

2025-07-17

Countries

• Switzerland

Study Locations