Status:
TERMINATED
Use of Progenitor Biological Bandages in Burn Care (Bru_PBB)
Lead Sponsor:
Dr Anthony De Buys Roessingh
Conditions:
Burn Injury
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
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...
Detailed Description
Study Product / Intervention: PBB (Progenitor Biological Bandages) produced at CHUV by the Cell Production Center are single-use therapies, which are applied on 2nd degree burns, defined as superfici...
Eligibility Criteria
Inclusion
- ≤ 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
- Infected wounds
- Vitally unstable patients
- Known allergy or hypersensitivity to product of equine origin
- Refusal of the study by the participants or relatives
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2025
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT05339490
Start Date
July 1 2025
End Date
July 17 2025
Last Update
July 22 2025
Active Locations (1)
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1
University Hospital
Lausanne, Canton of Vaud, Switzerland, 1011