A gelatin-thrombin matrix for hemostasis after endoscopic sinus surgery

Woodworth, Bradford A.; Chandra, Rakesh K.; LeBenger, Jeffrey D.; Ilie, Bogdan; Schlosser, Rodney J.

doi:10.1016/j.amjoto.2007.11.008

« Previous Next »American Journal of Otolaryngology - Head and Neck Medicine and Surgery
Volume 30, Issue 1 , Pages 49-53, January 2009

A gelatin-thrombin matrix for hemostasis after endoscopic sinus surgery☆

Bradford A. Woodworth, MD
- Division of Otolaryngology, Department of Surgery, The University of Alabama at Birmingham, Birmingham, AL, USA
- Corresponding author. Division of Otolaryngology, Department of Surgery, BDB 563, 1530 3rd Avenues., Birmingham, AL 35294.
Rakesh K. Chandra, MD
- Department of Otolaryngology, The University of Tennessee, Memphis, TN, USA
- RKC current affiliation is the Department of Otolaryngology, Northwestern University, Feinberg School of Medicine, Chicago, IL.
Jeffrey D. LeBenger, MD
- Department of Otolaryngology, The Summit Medical Group, Summit, NJ, USA
Bogdan Ilie
- Johnson & Johnson Wound Management, Division of Ethicon Inc, Somerville, NJ, USA
Rodney J. Schlosser, MD
- Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina Hospital, PO Box 250550, Charleston, SC, USA

Received 17 September 2007 published online 16 June 2008.

Abstract

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.