CTRI/2024/02/062997尚未招募不适用
A Pivotal Study to Assess the Safety and Effectiveness of NovoSorb Biodegradable Temporizing Matrix (BTM) in the Treatment of Severe Burn Skin Injuries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Proportion of study lesions in both groups with complete wound closure after skin grafting. Assessment of clinical outcome by wound closure
研究概览
简要总结
This is a multicenter randomized clinical study to assess the safety and effectiveness of NovoSorb Biodegradable Temporizing Matrix (BTM) to treat patients with deep dermal or full thickness burns resulting from flame, flash, contract or scalding. Patients, 18 to 75 years of age, who have burns from 3% to 60%, inclusive, of their total body surface (TSBA) will be randomized to either the NovSorb BTM treatment group or the Standard of Care treatment group. The total number of patients to be enrolled in the global study is 150, India enrolled is to be 30. Study enrollment in India is expected to start in February of 2024. Subject participation, treatment plus follow-up period is approximately 20 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Provides written informed consent directly or via legally authorized representative (LAR) 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 female, 18 to 75 years of age.
- •Has deep dermal or full thickness thermal burns between 3% and 60% inclusive of their TBSA.
- •The % TBSA will be determined using the Lund and Browder chart.
- •The types of burns that will be assessed will include the following:• Scald including hot water, cooking oil, grease, etc.• Flame• Flash• Contact.
- •Has staged surgical procedures planned, e.g., one procedure to excise the burn eschar 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, i.e., has a negative pregnancy test at Day 0, prior to NovoSorb BTM being applied, non-breastfeeding, or are naturally postmenopausal, i.e., greater than 12 months of natural spontaneous amenorrhea or surgically sterile.
- •If of childbearing potential, agrees to use effective contraceptive methods throughout the course of the study.
排除标准
- •Has a known hypersensitivity to polyurethane 2.Only a non-burn injury has been experienced by the subject including soft-tissue degloving and friction burn or 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 or device that will interfere with NovoSorb® BTM integration
- •Anticipated inability to perform wound care and follow-up procedures
- •Anticipates a level of non-compliance
- •The use of off-label treatments for full-thickness or 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.
结局指标
主要结局
Proportion of study lesions in both groups with complete wound closure after skin grafting. Assessment of clinical outcome by wound closure
时间窗: 4 weeks after skin grafting
次要结局
未报告次要终点
研究者
Dr S Raja Sabapathy
Ganga Medical Centre and Hospitals PVT Ltd
研究点 (3)
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