A Phase 1/2a, Controlled, Randomized, Multicenter Study Evaluating the Efficacy, Safety, and Tolerability of StrataGraft Overlay of Meshed Autograft (SOMA) in Treatment of Full-Thickness Thermal Burns
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 5
- 主要终点
- Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2
研究概览
简要总结
Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the participant's own body (donor site) to the burned part. Autografting is the usual treatment for full-thickness (FT) burns.
It works to close the wound, but can cause other problems:
- Donor sites are painful, can become infected or scarred, or can even become FT wounds themselves
- Treatment problems can require more grafting
- Additional surgery increases risk of medical problems caused by the treatment
Stratatech is trying to find a safe and effective treatment option for severe burns that uses less donor skin.
All participants in this study received meshed autograft on one part of their burn (AG Tx). They received more widely meshed than AG Tx site autograft with a StrataGraft covering (SOMA Tx) on a different part of their burn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has 2% to 49% (inclusive) total body surface area (TBSA) thermal burn area, including areas of full thickness (FT) injury clinically indicated for surgical excision and autografting, appropriate for protocol-defined treatment areas
- •Meets protocol-specified criteria for qualification and contraception
- •Is willing and able to comply with all study procedures and requirements
- •Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
排除标准
- •Is a prisoner, pregnant, or had previous autografting to treatment sites
- •Is expected to survive less than 3 months
- •Is participating in another interventional trial, or did within 30 days before enrollment
- •Has anticipated treatment sites that are outside protocol-specified parameters
- •Has concurrent clinically significant inhalation injury, inadequate fluid resuscitation, or burns of chemical or electrical (non-thermal) etiology
- •Has other signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- •The safety or well-being of the participant
- •The study objectives
研究组 & 干预措施
Cohort1 Group1: AG Tx Sites
Participants received autograft treatment (AG Tx) consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.
干预措施: AG Tx (Procedure)
Cohort1 Group1: SOMA Tx Sites
Participants received StrataGraft overlay of meshed autograft (SOMA Tx) at the treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 square centimeters (cm^2) in area on Day 1.
干预措施: SOMA Tx (Biological)
Cohort1 Group 2: AG Tx Sites
Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.
干预措施: AG Tx (Procedure)
Cohort1 Group2: SOMA Tx Sites
Participants received SOMA Tx on the treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm^2 in area on Day 1.
干预措施: SOMA Tx (Biological)
结局指标
主要结局
Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2
时间窗: At Month 2
Confirmed complete wound closure was defined as complete skin re-epithelialization without drainage confirmed at 2 visits at least 2 weeks apart but no later than Week 20. Complete wound closure was considered to have occurred at the earlier of the 2 observations of complete skin re-epithelialization without drainage. The number of treatment sites with complete wound closure without additional autografting at Month 2 was reported.
Number of Participants With Durable Wound Closure of Study Treatment Sites Without Additional Autografting at Month 12
时间窗: At Month 12
Durable wound closure is defined as persistence of closure, maintained for at least 3 months after the initial observation of closure.
次要结局
未报告次要终点