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
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
- 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
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.
研究组 & 干预措施
FS 4IU VH S/D
FS 4IU VH S/D was administered intraoperatively to the wound bed by spray application using the TISSOMAT and Spray Set. Only the DUPLOJECTvii system and Spray Set (connection tube with sterile filter and spray head) device was used for simultaneous spray application of the study product. A thin layer of FS 4IU VH S/D was applied to the wound bed using a "painting motion" from side to side to achieve coverage. The recommended dosing volume was 2.0 to 4.0 mL/100 cm2. One 2-mL pack (4 mL total volume) of FS 4IU VH S/D applied using the TISSOMAT and Spray Set was sufficient to coat a wound bed of 100-200 cm2.
干预措施: Fibrin Sealant, ARTISS 4IU/ml VH SD (Biological)
Staples
Staples are the current standard of care in burn surgery and are well accepted as the control in this type of study.
干预措施: Staples (Other)
结局指标
主要结局
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
Adverse experiences (AEs) deemed possibly or probably related to treatment with FS 4IU VH S/D
时间窗: 12 months after treatment
次要结局
- 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)
- Presence of hematoma/seroma on Day 1(1 day after treatment)
- Percent area of hematoma/seroma on Day 1(1 day after treatment)