A Trial of Absorbable Regenerated Oxidized Cellulose for Surgical Hemostasis)

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.

NCT Number	NCT07764055
Lead Sponsor	Medprin Regenerative Medical Technologies Co., Ltd. Collaborators: Sir Run Run Shaw Hospital, Tongji Hospital, Tongji Medical College, HUST, Zhejiang Provincial People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Guangzhou Medical University
Conditions	Surgical Bleeding, Hemorrhage, Oxidized Regenerated Cellulose
Enrollment	288 participants
Start Date	2022-11-09
Primary Completion	2024-01-15 (estimated)
Study Completion	2024-03-05 (estimated)
Updated on ClinicalTrials.gov	2026-08-13