A Multicenter, Randomized, Single-Blind, Positive-Controlled Clinical Trial of Absorbable Multilayer Fibrillar 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.
Inclusion Criteria: * Age ≥ 18 years, any gender. * Patients scheduled for surgical procedures where adjunctive hemostasis is anticipated. * Patient and/or legal guardian has provided written informed consent.
Exclusion Criteria: * Participated in another clinical trial within 1 month prior to surgery. * Presence of acute infection. * Severe diseases of vital organs (heart, liver, kidney) or hematological diseases that would make the patient intolerant to surgery. * Known allergy to regenerated oxidized cellulose. * History of severe allergies or severe immunodeficiency. * Severe coagulation dysfunction (e.g., platelet count \< 50×10\^9/L, INR \> 2). * Life expectancy \< 6 months. * Pregnant or breastfeeding women. * Patients deemed non-compliant or unable to complete the study as judged by the investigator. * Unable to understand the study description provided by the investigator. * Any other condition deemed unsuitable for participation by the investigator (e.g., extensive trauma, extremely unstable vital signs, life-threatening massive bleeding).
[{"measure":"Hemostasis Success Rate within 5 Minutes","timeFrame":"Intraoperative (Day of surgery)"}]