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.
Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding
The SURGICEL® Powder Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding (China Study)