A Traditional Feasibility Study to Assess the Safety and Effectiveness of the Biodegradable Temporizing Matrix (BTM) in the Treatment of Deep Burn Skin Injuries.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 10
- 主要终点
- BTM 'Take' Rate
研究概览
简要总结
This is a multi-center, single arm, traditional feasibility study to allow a preliminary assessment of the safety and effectiveness of a new method of treating skin burns using Biodegradable Temporizing Matrix (BTM).
详细描述
This is a multi-center, single arm, traditional feasibility study to allow a preliminary assessment of the safety and effectiveness of BTM treatment. Patients with 10-70% TBSA burns will have BTM devices implanted in areas with deep partial or full thickness burns to treat at least 5% TBSA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provides written informed consent (directly or via legal representative) prior to any clinical trial procedures being performed.
- •Willing to comply with all study procedures and expects to be available for the duration of the study.
- •Male and non-pregnant females ≥ 18 years of age and ≤ 70 years of age.
- •Patients with deep partial or full thickness burns (between 10% and 70% inclusive of their TBSA).
排除标准
- •Has a known hypersensitivity to polyurethane or silver-containing materials.
- •Multiple traumas (significant traumatic injury to a solid organ in addition to skin).
- •Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy.
- •Presence of a medical condition that might interfere with treatment evaluation; or require a change in therapy including but not limited to, significant immune deficiency, or skin or vascular diseases in the area of the wound.
- •Female with known or suspected pregnancy, planned pregnancy, or lactation.
- •Has had exposure to any other investigational agent within the last 6 months.
- •Has a clinically significant psychiatric illness.
- •Has a condition the Investigator believes would interfere with the ability to comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk.
结局指标
主要结局
BTM 'Take' Rate
时间窗: At time of application of split skin graft (SSG) (typically 28-35 days after application of BTM, Day 0)
Percentage of total body surface area (%TBSA) of BTM that has adhered at time of skin grafting, divided by the %TBSA treated with BTM, then multiplied by 100 to express as a percentage. Calculated per study lesion and averaged per participant.
SSG 'Take' Rate Over BTM
时间窗: 7-10 days after application of SSG
The amount (calculated as a percentage) of split skin graft (SSG) that 'takes' expressed as a proportion of SSG applied at 7-10 days after application of SSG. Calculated per study lesion and averaged for each participant.
Adverse Events
时间窗: All timepoints until 12 months after application of SSG
Number and type of Adverse Events occurring after BTM implantation
次要结局
- Wound Closure - Right Lower Limb(1, 2, 3, 6, 12 months after application of SSG)
- Wound Closure - Left Upper Limb(1, 2, 3, 6, 12 months after application of SSG)
- Skin Itch(At 1, 2, 3, 6, 12 months after application of SSG)
- Infection(From day of application (Day 0) until 12 months after SSG.)
- Wound Closure - Anterior Torso(1, 2, 3, 6, 12 months after application of SSG)
- Wound Closure - Left Lower Limb(1, 2, 3, 6, 12 months after application of SSG)
- Ease of Use: "BTM is Easy to Apply"(At time of application of SSG (typically 28-35 days after application of BTM, Day 0))
- Ease of Use: "BTM is Easy to Delaminate"(At time of application of SSG (typically 28-35 days after application of BTM, Day 0))
- Ease of Use: "BTM is a Product I Would Use for Other Burn Patients"(At time of application of SSG (typically 28-35 days after application of BTM, Day 0))
- Scar Severity(1, 2, 3, 6 and 12 months after application of SSG)
- Wound Closure - Posterior Torso(1, 2, 3, 6, 12 months after application of SSG)
- Ease of Use: "BTM is Easy to Use"(At time of application of SSG (typically 28-35 days after application of BTM, Day 0))
- Joint Contracture(1, 2, 3, 6, 12 months after application of BTM)