Jason A Beyea1, Brian W Rotenberg. 1. Department of Otolaryngology-Head and Neck Surgery, University of Western Ontario, London, Canada.
Abstract
OBJECTIVES:Purified plant polysaccharide (HemoStase) is a plant-derived hemostatic agent that has not previously been used in sinus surgery. This study was conducted to evaluate the effectiveness of this novel agent in the control of nasal bleeding during endoscopic sinus surgery. The volume of bleeding during endoscopic sinus surgery was hypothesized to not be statistically significantly different between a control group (gelatin-thrombin matrix; FloSeal) and an experimental group (purified plant polysaccharide; HemoStase). METHODS:Eighteen patients with a history of chronic rhinosinusitis in whom maximal medical therapy failed who underwent endoscopic sinus surgery were randomized into one of two groups (control FloSeal group or experimental HemoStase group). In the control group, sites in the nose that were actively bleeding during the operation were controlled with FloSeal. In the experimental group, sites in the nose that were actively bleeding during the operation were controlled with HemoStase. The main outcome measure was total operative blood loss. Blood loss was the sum of blood removed by suction during the surgery (recorded in milliliters) and blood on surgical sponges (weighed and converted to milliliters). Statistical analysis was performed with the t-test and the Mann-Whitney U test. RESULTS: The amounts of blood loss (mean +/- SEM) were not significantly different between the FloSeal (262 +/- 15 mL) and HemoStase (265 +/- 33 mL) groups (p = 0.93). CONCLUSIONS: The results of this study demonstrate the use of a novel product for the control of intraoperative bleeding during endoscopic sinus surgery.
RCT Entities:
OBJECTIVES: Purified plant polysaccharide (HemoStase) is a plant-derived hemostatic agent that has not previously been used in sinus surgery. This study was conducted to evaluate the effectiveness of this novel agent in the control of nasal bleeding during endoscopic sinus surgery. The volume of bleeding during endoscopic sinus surgery was hypothesized to not be statistically significantly different between a control group (gelatin-thrombin matrix; FloSeal) and an experimental group (purified plant polysaccharide; HemoStase). METHODS: Eighteen patients with a history of chronic rhinosinusitis in whom maximal medical therapy failed who underwent endoscopic sinus surgery were randomized into one of two groups (control FloSeal group or experimental HemoStase group). In the control group, sites in the nose that were actively bleeding during the operation were controlled with FloSeal. In the experimental group, sites in the nose that were actively bleeding during the operation were controlled with HemoStase. The main outcome measure was total operative blood loss. Blood loss was the sum of blood removed by suction during the surgery (recorded in milliliters) and blood on surgical sponges (weighed and converted to milliliters). Statistical analysis was performed with the t-test and the Mann-Whitney U test. RESULTS: The amounts of blood loss (mean +/- SEM) were not significantly different between the FloSeal (262 +/- 15 mL) and HemoStase (265 +/- 33 mL) groups (p = 0.93). CONCLUSIONS: The results of this study demonstrate the use of a novel product for the control of intraoperative bleeding during endoscopic sinus surgery.