A Multicenter, Single-Blind, Randomized Controlled Clinical Trial of the Safety and Efficacy of Absorbable Hemostatic Fluid Gelatin for Surgical Hemostasis
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 324
- Primary Endpoint
- 5-Minute Hemostasis Success Rate
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: 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
Intervention: Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic Matrix (Device)
Outcomes
Primary Outcomes
5-Minute Hemostasis Success Rate
Time Frame: Intraoperative (Day of surgery)
Secondary Outcomes
- 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))