Evaluation of the Safety and Effectiveness of Progenitor Biological Bandages in Burn Care
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Wound re-epithelialization assessment at Day 10
研究概览
简要总结
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.
详细描述
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 superficial to partial-thickness burns, and DSW (Donor Site Wound). They can be applied on complex anatomies (moldable) in adults and children of both genders after cleaning of the wounds through showering and debridement. The application of these PBB is prescribed by a specialized surgeon to a patient incapable of spontaneous burn closure and they are only used by health professionals at the CHUV Burn Center. PBB are composed of human skin progenitor cells (FE002- SK2 cell type) originated from a clinical GMP cell bank and seeded on a biodegradable horse collagen scaffold (9x12 cm, Resorba® Medical). PBB are delivered directly to the surgeon in the operating room after a production period of at least 18 hours. The number of PBB ordered by the physician depends on the burned surface area to be treated. They are maintained in the appropriate medium in controlled conditions until delivery and application. They must be applied no later than 72 hours after the start of production. Treatment duration with PBB is 10-12 days post injury for 2nd degree burn wounds and 15 days post DSW creation for DSW.
Control Intervention (if applicable):
To evaluate the performance of treatment with PBB, the investigators plan to compare in a randomization process the efficacy of PBB against a control intervention with Jelonet®. Jelonet® is the standard treatment for treating a DSW when a skin autograft is needed for 2nd and 3rd degree burned patients. The DSW is performed by using a dermatome (Aesculap®, Braun) to retrieve healthy skin (0.2 mm depth) when a skin graft is required to treat burn wound. The DSW is similar to a 2nd degree superficial burn and is able to heal by treatment with Jelonet® dressings (Paraffin Gauze Dressings, 10cm x 10 cm, Smith & Nephew, UK). The advantage to compare treatments efficacies on a DSW is due to the homogenous properties of a DSW, in comparison to the heterogeneous aspect of a burn wound. Treatment duration of DSW with Jelonet® is 15 days after the creation of DSW.
Measurements and procedures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≤ 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
排除标准
- •Infected wounds
- •Vitally unstable patients
- •Known allergy or hypersensitivity to product of equine origin
- •Refusal of the study by the participants or relatives
研究组 & 干预措施
Progenitor Biological Bandages
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.
干预措施: Progenitor Biological Bandages (Drug)
Jelonet
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.
干预措施: Jelonet (Device)
结局指标
主要结局
Wound re-epithelialization assessment at Day 10
时间窗: Day 10 of treatment
95 percent skin re-epithelialization (yes or no) will be assessed 10 days after the start of treatment and creation of the DSW
次要结局
- Short-term efficacy of treatment(Day 5, Day 10, and Day 15 of treatment)
- Long-term skin quality - Elastography(From 1 month to 5 years post skin closure)
- 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)
研究者
Dr Anthony De Buys Roessingh
Principal investigator
Centre Hospitalier Universitaire Vaudois