A gelatin-thrombin matrix for hemostasis after endoscopic sinus surgery.
OBJECTIVE
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.


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.
Woodworth
Bradford A
BA
Division of Otolaryngology, Department of Surgery, The University of Alabama at Birmingham, Birmingham, AL 35294, USA. bwoodwo@hotmail.com
Chandra
Rakesh K
RK
LeBenger
Jeffrey D
JD
Ilie
Bogdan
B
Schlosser
Rodney J
RJ
D000328:Adult; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D004724:Endoscopy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010254:Paranasal Sinus Diseases / Q000175:diagnosis / Q000601:surgery*; D017060:Patient Satisfaction; D011446:Prospective Studies; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013917:Thrombin / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D006490:Hemostatics; D013917:Thrombin