Purpose: Adequate hemostasis is necessary after endoscopic sinus surgery. This study evaluated the clinical performance of Surgiflo hemostatic matrix (Johnson&Johnson Wound Management, a division of Ethicon Inc, Somerville, NJ) with Thrombin-JMI (distributed by Jones Pharma Inc, Bristol, VA, a wholly owned subsidiary of King Pharmaceuticals, Bristol, TN) in achieving hemostasis in patients undergoing endoscopic sinus surgery. Surgiflo hemostatic matrix is a sterile, absorbable porcine gelatin intended to aid with hemostasis when applied to a bleeding surface.
Materials and methods: This multicenter, prospective, single-arm study evaluated the success in achieving hemostasis within 10 minutes of product application in patients undergoing elective primary or revision endoscopic sinus surgery for chronic sinusitis with a bleeding surface requiring hemostasis. Patient satisfaction and postoperative healing were also evaluated.
Results: Thirty patients were enrolled, including 17 males and 13 females (average age, 48.2 +/- 15.1 years), with 54 operated sides. Twenty-nine patients achieved hemostasis within 10 minutes of product application (96.7% success rate; 1-sided 95% confidence interval, 85.1%-100%). The median total time to hemostasis including manual compression was 61 seconds. No complications, such as synechiae, adhesion, or infection, were reported.
Conclusions: Surgiflo hemostatic matrix with Thrombin-JMI was clinically effective in controlling bleeding in 96.7% of patients. Further randomized controlled trials are indicated.