A Prospective, RCT Evaluating the Safety and Hemostatic Effectiveness of SURGICEL Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding During Surgery in Chinese Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 试验地点
- 6
- 主要终点
- Hemostatic Success at 5 Minutes
研究概览
简要总结
This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in Chinese adult subjects.
详细描述
This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in Chinese adult subjects.
After application of either SURGICEL Powder or SURGICEL Original, the target bleeding site (TBS) will be assessed for hemostasis (no detectable bleeding) at 3, 5, and 10 minutes from application and prior to initiation of final fascial closure on open surgery or port site closure in laparoscopic or thoracoscopic procedures.
All enrolled subjects will be observed post-operatively through discharge and followed up at 30 days (+14 days) and at 6 months (+/-30 days) post-surgery via phone call or office visit.
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 (Participant)
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
- •Adult subjects aged ≥18 years requiring elective/non-emergent open or laparoscopic general, gynecological, or cardiothoracic surgical procedures.
- •Subject or authorized representative has signed the approved Informed Consent.
- •Subject(s) whose platelet count is ≥100,000 per microliter and International Normalized Ratio (INR) is <1.5 prior to 24 hours of surgery.
- •Presence of an appropriate TBS identified intra-operatively by the surgeon.
- •Subject(s) undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to TBS identification and treatment.
排除标准
- •Female subjects who are pregnant or nursing.
- •Subject on heparin within 12 hours prior to surgery, or oral Coumadin (warfarin) and/or Factor Xa inhibitors within 3 days prior to surgery.
- •Subject on antiplatelet/P2Y12 inhibitors medication 5 days prior to surgery;
- •Subject is currently participating or plans to participate in any other investigational product or drug trial without prior approval from the Sponsor.
- •Subjects who are known, current alcohol and/or drug abusers.
- •Subjects with any pre-operative findings identified by the surgeon that may preclude conduct of the study procedure.
- •Subjects with any intra-operative findings identified by the surgeon that may preclude the use of study product.
- •Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected; see Appendix 1).
- •TBS is on arteries or veins where application of SURGICEL Powder would present a risk of introducing the study product into an open blood vessel.
- •Major arterial or venous bleeding or major defects in arteries and veins.
- •TBS where silver nitrate or any other escharotic chemicals have been applied.
- •TBS is in, around, or in proximity to foramina in bone, or areas of bony
结局指标
主要结局
Hemostatic Success at 5 Minutes
时间窗: From product application to 5 minutes following product application
Percentage of subjects achieving hemostatic success at 5 minutes following study product application with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure
次要结局
- Hemostatic Success at 3 Minutes(From product application to 3 minutes following product application)
- Hemostatic Success at 10 Minutes(From product application to 10 minutes following product application)