A Trial of Absorbable Regenerated Oxidized Cellulose for Surgical Hemostasis)

This is a multicenter, randomized, single‐blind, positive‐controlled, non‐inferiorityclinical trial. The purpose is to evaluate the safety and effectiveness of the absorbablemultilayer fibrillar regenerated oxidized cellulose in controlling capillary, venous, andsmall arteriole bleeding during surgical procedures when ligation or other conventionalmethods 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±15days and 180±30 days post‐surgery. The primary efficacy endpoint is the hemostasissuccess rate within 5 minutes.