A Multicenter, Single-Blind, Randomized Controlled Clinical Trial of the Safety and Efficacy of Absorbable Hemostatic Fluid Gelatin for Surgical Hemostasis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 324
- 主要终点
- 5-Minute Hemostasis Success Rate
研究概览
简要总结
This is a multicenter, single-blind, randomized controlled, non-inferiority trial evaluating the safety and efficacy of an absorbable hemostatic fluid gelatin for surgical hemostasis. Subjects are patients undergoing elective/semi-elective surgeries in General Surgery, Orthopedics, and Gynecology. The test group receives the investigational device, while the control group receives a marketed predicate device (SURGIFLO). The primary outcome is the 5-minute hemostasis success rate at the Target Bleeding Site (TBS).
详细描述
This trial enrolls 324 participants (162 per group) across General Surgery, Orthopedics, and Gynecology, with equal allocation per specialty (108 each). Each subject has one Target Bleeding Site (TBS). After conventional hemostasis fails or is not applicable, subjects are randomized to receive either the test or control device. Time from product application (T0) to hemostasis (TF) is recorded. Postoperative follow-up extends to 4 months, assessing adverse events, drainage volume, and laboratory changes.
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
- •1. Age ≥18 years;
- •2. Scheduled for elective/semi-elective surgery in General Surgery, Orthopedics, or Gynecology;
- •3. Signed informed consent. (Intra-op):
- •Presence of a suitable Target Bleeding Site (TBS).
排除标准
- •1. Allergy to porcine gelatin or refusal of porcine-derived products;
- •2. INR>1.5 or PLT<100×10⁹/L;
- •3. Severe hepatic/renal dysfunction;
- •4. Pregnancy/lactation;
- •5. Participation in another trial within 30 days;
- •6. Unsuitable per investigator.
研究组 & 干预措施
Absorbable Hemostatic Fluid Gelatin
Composed of fluid gelatin preloaded in a syringe with catheter components; gelatin derived from porcine skin. Applied to TBS and covered with moist gauze during surgery.
干预措施: Absorbable Hemostatic Fluid Gelatin (Device)
SURGIFLO™ Hemostatic Matrix
This product is a flowable hemostatic material made from a porcine skin-derived gelatin matrix, intended to control bleeding from capillaries, veins, and small arteries during surgical procedures
干预措施: Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic Matrix (Device)
结局指标
主要结局
5-Minute Hemostasis Success Rate
时间窗: Intraoperative (Day of surgery)
次要结局
- 3-Minute Hemostasis Success Rate(Intraoperative (Day of surgery))
- Wound Hemostasis Time (T)(Intraoperative (Day of surgery))
- Total Postoperative Drainage Volume(Perioperative period (time from end of surgery to patient's removal of drainage tube))
- Device Usability Evaluation(Intraoperative (Day of surgery))