NCT04090424进行中（未招募）不适用
A Pivotal Study to Assess the Safety and Effectiveness of NovoSorb® Biodegradable Temporizing Matrix (BTM) in the Treatment of Severe Burn Skin Injuries
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 26
- 主要终点
- Proportion of study lesions in both groups with complete wound closure after skin grafting
研究概览
简要总结
This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb® Biodegradable Temporizing Matrix (BTM).
详细描述
This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb® Biodegradable Temporizing Matrix (BTM). A comparison will be made between burn wounds treated with BTM and the institution's standard of care (SOC).
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent directly or via legal representative prior to any clinical study procedures being performed
- •Willing to comply with all study procedures and expects to be available for the duration of the study
- •Male and females ≥ 18 years of age and ≤ 75 years of age
- •Patients with deep dermal or full thickness burns between 3% and 60%, inclusive, of their total body surface area (TBSA).
- •Types of burns include the following:
- •Scalding including from hot water, cooking oil, grease
- •Subjects who have staged surgical procedures planned e.g., one procedure to excise the burn injury and a later procedure to prepare the wound bed and apply an autologous skin graft.
- •The minimum total area across all lesions to have NovoSorb® BTM applied is 3% TBSA
- •Females, who are non-pregnant, naturally postmenopausal, or who agree to use effective contraceptive methods throughout the course of the study.
排除标准
- •Has a known hypersensitivity to polyurethane
- •Only a non-burn injury has been experienced by the subject including soft-tissue degloving and friction burn/crush, i.e., road rash
- •Multiple traumas, i.e., 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
- •For females - has known or suspected pregnancy, planned pregnancy, or during lactation
- •Has exposure to any other investigational agent within the last 6 months
- •Has exposure to any other treatment/device that will interfere with NovoSorb® BTM integration
- •Anticipated inability to perform wound care and follow-up procedures
- •Anticipates of a level of non-compliance
- •The use of off-label treatments for full-thickness / deep-dermal burns is not permitted
- •Clinical signs of wound infection at areas to be potentially treated using NovoSorb® BTM that in the opinion of the investigator may compromise safety and study objectives
- •The use of NovoSorb® BTM on the face and in the perineum area is not permitted
研究组 & 干预措施
NovoSorb BTM
Experimental
Application of NovoSorb BTM to study lesions
干预措施: NovoSorb BTM (Device)
Standard of Care
Active Comparator
Application of the institution's standard of care to study lesions.
干预措施: Standard of Care (Procedure)
结局指标
主要结局
Proportion of study lesions in both groups with complete wound closure after skin grafting
时间窗: 4 weeks after skin grafting
Assessment of clinical outcome by wound closure
次要结局
未报告次要终点
研究者
研究点 (26)
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