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A Trial of Absorbable Regenerated Oxidized Cellulose for Surgical Hemostasis)
Sponsor: Medprin Regenerative Medical Technologies Co., Ltd.
Summary
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.
Official title: A Multicenter, Randomized, Single-Blind, Positive-Controlled Clinical Trial of Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose for Surgical Hemostasis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
288
Start Date
2022-11-09
Completion Date
2024-03-05
Last Updated
2026-08-13
Healthy Volunteers
No
Interventions
Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose
A sterile, absorbable, multilayer fibrillar regenerated oxidized cellulose dressing intended for use as an adjunctive hemostatic agent to control capillary, venous, and small arteriole bleeding during surgical procedures. The product is applied directly to the bleeding site and can be layered as needed. It is absorbed in the body over time.
SURGICEL Absorbable Hemostat (Absorbable Hemostatic Gauze)
A sterile, absorbable oxidized regenerated cellulose hemostatic dressing indicated for use as an adjunctive hemostatic agent to control capillary, venous, and small arteriole bleeding during surgical procedures. The product is applied directly to the bleeding site and is absorbed in the body.
Locations (6)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China