A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of ETHIZIA™ Versus SURGICEL® Original in Controlling Minimal, Mild, or Moderate Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic, Thoracic (Non-cardiac) and Extremity Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 12
- 主要终点
- Percentage of Cases Achieving Hemostasis at Three Minutes Following Product Application And With No Rebleeding Up to 10 Minutes Following Application at The Target Bleeding Site
研究概览
简要总结
The objective of this clinical investigation is to evaluate the safety and efficacy of ETHIZIA to control minimal, mild, or moderate soft tissue bleeding during open surgery when compared to SURGICEL Original in the percentage of cases achieving hemostasis at 3 minutes after product application, and without re-bleeding up to 10 minutes after application.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-operative
- •Participant is scheduled to undergo an elective open, abdominal, retroperitoneal, pelvic, thoracic (non-cardiac) or extremity surgical procedure
- •Participant is willing and able to give written informed consent for the clinical investigation participation
- •Intra-operative
- •Participant in whom the Investigator can identify and visualize a target bleeding site for which any applicable conventional means for hemostasis (e.g., suture, ligature, or cautery) are ineffective or impractical
- •Target Bleeding Site is identified to originate from soft tissue, defined as organ bed, loose areolar tissue, fat, lymphatic tissue/lymph node beds, and muscle
- •The choice is made to use a hemostatic agent to stop the bleeding, and there is the ability to apply pressure on the surface of the hemostatic agent to achieve hemostasis
- •Participant has a Target Bleeding Site with a SBSS score of 1, 2, or 3 (e.g., reflecting minimal, mild, or moderate bleeding severities)
排除标准
- •Pre-operative
- •Participant is scheduled for another planned surgery within the follow-up period and the subsequent surgery would jeopardize the ETHIZIA or SURGICEL Original application
- •Participant is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, but allowing exclusive use of acetylsalicylic acid
- •Participant has an active or suspected infection at the bleeding site
- •Participant is pregnant, planning on becoming pregnant, or actively breastfeeding during the 28-day follow-up period
- •Intra-operative
- •Target bleeding site is identified to originate from parenchymal organ tissue, cardiovascular (anastomotic or cardiovascular repair sites) tissue, or is in proximity to a foramina in bone, or areas of bony confine
- •Target bleeding site is from a large defect in an artery or vein that requires vascular reconstruction with maintenance of vessel patency
研究组 & 干预措施
ETHIZIA
ETHIZIA will be applied at bleeding sites that meet the inclusion criteria in participants undergoing open surgery to control soft tissue bleeding. Participants will be followed up for 28 days after surgery.
干预措施: ETHIZIA (Device)
SURGICEL Original
SURGICEL Original will be applied at bleeding sites that meet the inclusion criteria in participants undergoing open surgery to control soft tissue bleeding. Participants will be followed-up for 28 days after surgery.
干预措施: SURGICEL Original (Device)
结局指标
主要结局
Percentage of Cases Achieving Hemostasis at Three Minutes Following Product Application And With No Rebleeding Up to 10 Minutes Following Application at The Target Bleeding Site
时间窗: Intraoperative (up to 10 minutes)
Cases achieving hemostasis at 3 minutes following product application \& with no rebleeding up to 10 minutes following application at the target bleeding site (first bleeding site treated) will be determined by Surface Bleeding Severity Scale (SBSS). SBSS provides a clinically validated score for assessment of bleeding at the target site, and consists of 6 scores (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, not immediately life-threatening, 5 = extreme, immediately life-threatening). A grade of 0 (None/Dry) on the SBSS is considered as achieving hemostasis.
次要结局
- Time to Hemostasis at Target Bleeding Site(Intraoperative (up to 10 minutes))
- Median Time to Hemostasis at Target Bleeding Site(Intraoperative)
- Median Time to Hemostasis for All Treated Bleeding Sites(Intraoperative)
- Time to Hemostasis for All Treated Bleeding Sites(Intraoperative (up to 10 minutes))
- Percentage of Bleeding Sites Achieving Hemostasis with ETHIZIA or SURGICEL Original(At 30, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 seconds)
- Time to Hemostasis at Target Bleeding Site(Intraoperative (up to 10 minutes))
- Percentage of Bleeding Sites Achieving Hemostasis at Three Minutes Following Product Application And With No Rebleeding Up to 10 Minutes Following Application at All Treated Bleeding Sites(Intraoperative (up to 10 minutes))
- Time to Hemostasis for All Treated Bleeding Sites(Intraoperative (up to 10 minutes))
- Median Time to Hemostasis at Target Bleeding Site(Intraoperative)
- Median Time to Hemostasis for All Treated Bleeding Sites(Intraoperative)
- Treatment Failure for Target Bleeding Site Treated and for All Treated Bleeding Sites(Intraoperative (up to 10 minutes))
- Sustained Hemostasis at All Treated Bleeding Sites(Intraoperative)
- Proportion of Bleeding Sites with Rebleeding After 10 Minutes(Intraoperative)
- Percentage of Bleeding Sites Achieving Hemostasis with ETHIZIA or SURGICEL Original(At 30, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 seconds)
- Proportion of Bleeding Sites Requiring More Than One Application of ETHIZIA or SURGICEL Original to Achieve Hemostasis(Intraoperative)
- Proportion of Bleeding Sites that Require a Second Surgical Maneuver to Achieve Hemostasis(Intraoperative)