A Multicenter, Randomized, Single-Blind, Positive-Controlled Clinical Trial of Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose for Surgical Hemostasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 288
- 试验地点
- 6
- 主要终点
- Hemostasis Success Rate within 5 Minutes
研究概览
简要总结
This is a multicenter, randomized, single-blind, positive-controlled, non-inferiority clinical trial. The purpose is to evaluate the safety and effectiveness of the absorbable multilayer fibrillar regenerated oxidized cellulose in controlling capillary, venous, and small arteriole bleeding during surgical procedures when ligation or other conventional methods are ineffective or impractical. A total of 288 subjects (144 in the test group, 144 in the control group) will be enrolled across 6 centers (General Surgery, Cardiothoracic Surgery, Gynecology, and Urology). Subjects will be followed up at 30±15 days and 180±30 days post-surgery. The primary efficacy endpoint is the hemostasis success rate within 5 minutes.
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
- •Age ≥ 18 years, any gender.
- •Patients scheduled for surgical procedures where adjunctive hemostasis is anticipated.
- •Patient and/or legal guardian has provided written informed consent.
排除标准
- •Participated in another clinical trial within 1 month prior to surgery.
- •Presence of acute infection.
- •Severe diseases of vital organs (heart, liver, kidney) or hematological diseases that would make the patient intolerant to surgery.
- •Known allergy to regenerated oxidized cellulose.
- •History of severe allergies or severe immunodeficiency.
- •Severe coagulation dysfunction (e.g., platelet count < 50×10^9/L, INR > 2).
- •Life expectancy < 6 months.
- •Pregnant or breastfeeding women.
- •Patients deemed non-compliant or unable to complete the study as judged by the investigator.
- •Unable to understand the study description provided by the investigator.
- •Any other condition deemed unsuitable for participation by the investigator (e.g., extensive trauma, extremely unstable vital signs, life-threatening massive bleeding).
研究组 & 干预措施
Experimental: Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose
Subjects undergoing surgical procedures (including general surgery, cardiothoracic surgery, gynecology, and urology) who require adjunctive hemostasis for capillary, venous, and small arteriole bleeding when ligation or other conventional methods are ineffective or impractical. The test device is applied to the Target Bleeding Site (TBS) as an adjunctive hemostatic agent.
干预措施: Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose (Device)
Active Comparator: SURGICEL Absorbable Hemostat
Subjects undergoing surgical procedures (including general surgery, cardiothoracic surgery, gynecology, and urology) who require adjunctive hemostasis for capillary, venous, and small arteriole bleeding when ligation or other conventional methods are ineffective or impractical. The control device is applied to the Target Bleeding Site (TBS) as an adjunctive hemostatic agent per its approved labeling.
干预措施: SURGICEL Absorbable Hemostat (Absorbable Hemostatic Gauze) (Device)
结局指标
主要结局
Hemostasis Success Rate within 5 Minutes
时间窗: Intraoperative (Day of surgery)
Success is defined as the cessation of bleeding (no persistent oozing from the target bleeding site, TBS) within 5 minutes from the time the product is fully applied to the TBS. Failure is defined as bleeding lasting \>5 minutes.
次要结局
- Time to Hemostasis(Intraoperative (Day of surgery))
- Device Usability Evaluation(Intraoperative (Day of surgery))