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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
288
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.
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.
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
Hemostasis Success Rate within 5 Minutes
Success is defined as the cessation of bleeding (no persistent oozing from the target bleeding site, TBS) within 5 minutes from the time the product is fully applied to the TBS. Failure is defined as bleeding lasting \>5 minutes.
Time frame: Intraoperative (Day of surgery)
Time to Hemostasis
Time measured from product application to the complete cessation of bleeding at the TBS.
Time frame: Intraoperative (Day of surgery)
Device Usability Evaluation
Evaluation of ease of use in endoscopic/laparoscopic procedures, adhesion to instruments, fit to the wound surface, and ease of layering.
Time frame: Intraoperative (Day of surgery)
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