Use of Progenitor Biological Bandages in Burn Care (Bru_PBB)

NCT05339490 | Terminated Phase 1

• 3 other identifiers: RA101062020-018732020TpP1010
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cell therapies; fetal progenitor cells; regenerative medicine; standardized transplants; wound healing

Outcome Measures

Primary Outcomes (1)

• Wound re-epithelialization assessment at Day 10

  95 percent skin re-epithelialization (yes or no) will be assessed 10 days after the start of treatment and creation of the DSW

  Day 10 of treatment

Secondary Outcomes (4)

• Short-term efficacy of treatment

  Day 5, Day 10, and Day 15 of treatment

• Long-term skin quality - Scar appearance (Vancouver Scar Scale)

  From 1 month to 5 years post skin closure

• Long-term skin quality - Scar colour

  From 1 month to 5 years post skin closure

• Long-term skin quality - Elastography

  From 1 month to 5 years post skin closure

Other Outcomes (2)

• Safety outcomes - wound infections

  Through study treatment, an average of 15 days for each treated wounds

• Safety outcomes - adverse events

  Through study completion, an average of 5 years

Study Arms (2)

Progenitor Biological Bandages

EXPERIMENTAL

Donor Site Wound (DSW) is created with a dermatome. PBB are placed on the wound and maintained in place with the help of classical bandages for a maximum of 15 ± 1 days. Dressing's changes are performed at Day 5 ± 1 and Day 10 ± 1.

Drug: Progenitor Biological Bandages

Jelonet

ACTIVE COMPARATOR

Donor Site Wound is created with a dermatome. Jelonet® are placed on the wound and maintained in place with the help of classical bandages for a maximum of 15 ± 1 days. Dressing's changes are performed at Day 5 ± 1 and Day 10 ± 1.

Device: Jelonet

Interventions

Progenitor Biological Bandages DRUG

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.

Also known as: PBB

Progenitor Biological Bandages

Jelonet DEVICE

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.

Jelonet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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

You may not qualify if:

• Infected wounds
• Vitally unstable patients
• Known allergy or hypersensitivity to product of equine origin
• Refusal of the study by the participants or relatives

Sponsors & Collaborators

• Dr Anthony De Buys Roessingh: lead

Study Sites (1)

University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (5)

• Hohlfeld J, de Buys Roessingh A, Hirt-Burri N, Chaubert P, Gerber S, Scaletta C, Hohlfeld P, Applegate LA. Tissue engineered fetal skin constructs for paediatric burns. Lancet. 2005 Sep 3-9;366(9488):840-2. doi: 10.1016/S0140-6736(05)67107-3.

  PMID: 16139659 BACKGROUND

• De Buys Roessingh AS, Hohlfeld J, Scaletta C, Hirt-Burri N, Gerber S, Hohlfeld P, Gebbers JO, Applegate LA. Development, characterization, and use of a fetal skin cell bank for tissue engineering in wound healing. Cell Transplant. 2006;15(8-9):823-34. doi: 10.3727/000000006783981459.

  PMID: 17269452 BACKGROUND

• Abdel-Sayed P, Michetti M, Scaletta C, Flahaut M, Hirt-Burri N, de Buys Roessingh A, Raffoul W, Applegate LA. Cell therapies for skin regeneration: an overview of 40 years of experience in burn units. Swiss Med Wkly. 2019 May 19;149:w20079. doi: 10.4414/smw.2019.20079. eCollection 2019 May 6.

  PMID: 31104308 BACKGROUND

• Abdel-Sayed P, Hirt-Burri N, de Buys Roessingh A, Raffoul W, Applegate LA. Evolution of Biological Bandages as First Cover for Burn Patients. Adv Wound Care (New Rochelle). 2019 Nov 1;8(11):555-564. doi: 10.1089/wound.2019.1037. Epub 2019 Oct 16.

  PMID: 31637102 BACKGROUND

• Laurent A, Lin P, Scaletta C, Hirt-Burri N, Michetti M, de Buys Roessingh AS, Raffoul W, She BR, Applegate LA. Bringing Safe and Standardized Cell Therapies to Industrialized Processing for Burns and Wounds. Front Bioeng Biotechnol. 2020 Jun 19;8:581. doi: 10.3389/fbioe.2020.00581. eCollection 2020.

  PMID: 32637400 BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Anthony De Buys Roessingh

  Lausanne Burn Center, Lausanne University Hospital CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 21, 2022
• Study Start: July 1, 2025
• Primary Completion: July 17, 2025
• Study Completion: July 17, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)