A Multicenter, Open-label, Study of StrataGraft® Skin Tissue in Adult Subjects With Deep Partial-Thickness Thermal Burns
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 20
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
An autograft is a piece of skin taken from a healthy area of the body to be used to treat severe burns on another part of the same body.
StrataGraft skin tissue was an investigational tissue that could be used as an alternative to an autograft.
- StrataGraft skin tissue was in late-stage clinical development for the treatment of adults with deep partial-thickness (DPT) burns.
- There were no safety concerns reported to date. The sponsor submitted a treatment protocol to Food and Drug Administration (FDA) for doctors who participated in the Phase 3 Strata 2016 study (NCT 03005106) to allow for expanded access to StrataGraft before it was commercially available.
The main purpose of the study was to allow patients to receive StrataGraft during Biologics License Application review and prior to approval by the FDA for the treatment of DPT burns. The primary outcome measure was the number of participants with adverse events and safety concerns.
详细描述
The primary purpose of this trial was to provide expanded access to StrataGraft for thermally induced DPT burns that contained intact dermal elements and for which surgical excision and autograft would normally be part of the clinical management.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be considered for inclusion, a participant must:
- •Provide written informed consent
- •Have enough healthy skin to reserve as donor site(s), in case autografting becomes necessary
- •Have protocol-defined thermal burn(s) on the torso, upper extremities and lower extremities:
- •that are the right size for treatment areas,
- •with intact dermal elements for which excision and autografting are clinically indicated, and
- •have not been previously excised and grafted.
排除标准
- •A participant must be excluded from participation if he/she:
- •Is pregnant, a prisoner, or expected to live less than 3 months
- •Has any other condition that, per protocol or in the opinion of the investigator, may compromise the participant's safety or the study objectives
- •Has participated in an investigational study within 90 days before enrollment
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: AEs were collected on each individual participant for the duration of their study participation, i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. A TEAE is defined as an adverse event that started on or after the start of treatment (i.e. placement of StrataGraft).
次要结局
未报告次要终点