Absorbable Hemostatic Fluid Gelatin Trial
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).
1. Age ≥18 years; [+2]
1. Allergy to porcine gelatin or refusal of porcine-derived products; [+5]