Burn Injury Clinical Trial
— Bru_PBBOfficial title:
Evaluation of the Safety and Effectiveness of Progenitor Biological Bandages in Burn Care
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.
Status | Not yet recruiting |
Enrollment | 76 |
Est. completion date | January 1, 2035 |
Est. primary completion date | January 1, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Dr Anthony De Buys Roessingh |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
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Other | Safety outcomes - wound infections | Incidence of wound infections will be monitored according to microbiological assessment on tissue biopsy in case of infection suspicion of the wound. | Through study treatment, an average of 15 days for each treated wounds | |
Other | Safety outcomes - adverse events | Incidence of adverse events from initial treatment through last study visit. The AEs and SAEs will be assessed by the physician (type, duration, severity, relationship to the investigational medicinal product and need for treatment) and graded according to the CTCAE version 5.0 | Through study completion, an average of 5 years | |
Primary | 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 | Short-term efficacy of treatment | Percentage of re-epithelialization (percent) by measuring the length (cm) and height (cm) of the wound at each evaluation time point compared to Day 1 of treatment | Day 5, Day 10, and Day 15 of treatment | |
Secondary | Long-term skin quality - Scar appearance (Vancouver Scar Scale) | The Vancouver scale allows to measure scar appearance by evaluation of scores for:
skin pliability (0=Normal; 1=Supple; 2=Yielding; 3=Firm; 4=Adherent), skin vascularization (0=Normal; 1=Pink; 2=Red; 3=Purple) skin pigmentation (0=Normal; 1=Hypopigmentation; 2=Mixed; 3=Hyperpigmentation). The quality of the skin is assessed both by vision and touch by medical experts for a better standardization. Higher scores mean a worse outcome. |
From 1 month to 5 years post skin closure | |
Secondary | Long-term skin quality - Scar colour | Scar colour will be evaluated with a probe-based skin analysis system from Cortex Technology. The erythema and melanin indexes (EI and MI) are read directly on the device with arbitrary units specific to the device (between 0 and 100). | From 1 month to 5 years post skin closure | |
Secondary | Long-term skin quality - Elastography | Elastic properties of the repaired skin (m/s) using a probe-based skin analysis system from Cortex Technology will be measured and compared to healthy skin. | From 1 month to 5 years post skin closure |
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