NCT00157131已完成3 期
A Study To Evaluate the Safety and Efficacy of Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS 4IU VH S/D) to Adhere Tissues and Improve Wound Healing
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 17
- 主要终点
- Adverse experiences (AEs) deemed possibly or probably related to treatment with FS 4IU VH S/D
研究概览
简要总结
The primary objective of this study is to evaluate skin graft adherence and wound healing in burn patients to evaluate whether FS 4IU VH S/D is equivalent or superior to the current standard of care (staples). The primary endpoint is achievement of complete (100%) wound closure within 28 days.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects or their legal representatives, who have read, understood and signed a written informed consent.
- •Subjects of either sex.
- •Female subjects of childbearing potential with a negative urine or serum pregnancy test on admission.
- •Subjects who are <= 65 years of age including pediatric subjects of all ages.
- •Subjects with total burn wounds measuring <= 40% TBSA.
- •Subjects with a contiguous deep partial thickness/full thickness wound, between 2% and 8% TBSA or two comparable, bilateral wounds each measuring between 1% and 4% TBSA.
- •Wounds designated as test sites require autologous sheet skin grafts with a thickness of 8/1000" - 16/1000"
- •Subjects who are able, and willing to comply with the procedures required by the protocol.
排除标准
- •Subjects with electrical burns.
- •Subjects with chemical burns
- •Digits and genitalia are excluded as test sites.
- •Subjects with infection at test area/test sites.
- •Subjects with test sites previously randomized and treated in this study.
- •Subjects with venous or arterial vascular disorder that directly affects a designated test area/test site.
- •Subjects with pre-existing hemolytic anemia
- •Subjects with diabetes mellitus.
- •Subjects with documented history of pathologically or pharmacologically induced immune deficiency.
- •Subjects judged to be chronically malnourished.
- •Subjects that are judged to have significant pulmonary compromise.
- •Subjects receiving systemic corticosteroids within 30 days prior to skin grafting (not including inhaled steroids).
- •Subjects with known or suspected hypersensitivity to bovine proteins.
- •Subjects participating in another clinical trial that is evaluating an unapproved drug or device.
结局指标
主要结局
Adverse experiences (AEs) deemed possibly or probably related to treatment with FS 4IU VH S/D
时间窗: 12 months after treatment
Complete wound closure by Day 28 after treatment with either FS 4IU VH S/D or staples as determined by a blinded independent review of the Day 28 photographs
时间窗: 28 days after treatment
次要结局
- Presence of hematoma/seroma on Day 1(1 day after treatment)
- Percent area of hematoma/seroma on Day 1(1 day after treatment)
- 100% engraftment by Day 5(5 days after treatment)
- Percent area of engraftment on Day 5(5 days after treatment)
- Complete wound closure by Day 14(14 days after treatment)
- Scar maturation assessed by blinded Vancouver Scar Scale evaluations on Months 3, 6, 9, and 12(3, 6, 9, and 12 months after treatment)
- Percent area of closure by Days 14 and 28(14 and 28 days after treatment)
研究者
研究点 (17)
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