BACKGROUND:Postoperative bleeding and adhesion formation are the two most common complications after endoscopic sinus surgery (ESS). Continued bleeding risks airway compromise from the inhalation of blood clots and from the aspiration of blood-stained vomitus. Additionally, adhesion formation is the most common reason for patients requiring revision surgery. This study aimed to determine the efficacy of a novel chitosan/dextran (CD) gel on hemostasis and wound healing after ESS. METHODS: A randomized controlled trial was performed involving 40 patients undergoing ESS for chronic rhinosinusitis. Immediately after surgery a baseline Boezaart Surgical Field Grading Scale was taken. Computer randomization was performed with one side receiving CD gel and the other side receiving no treatment (control). Boezaart bleeding scores were then calculated for each side every 2 minutes. Patient's endoscopic features of wound healing were assessed at 2, 6, and 12 weeks after surgery. RESULTS:CD gel achieved rapid hemostasis with the mean time to hemostasis at 2 minutes (95% CI, 2-4 minutes) compared with 10 minutes (95% CI, > or =6 minutes) for the control (p < 0.001). There were significantly less adhesions at all time points with CD gel versus control: 2 versus 18 at 2 weeks (p < 0.001), 3 versus 16 at 6 weeks (p < 0.001), and 2 versus 12 at 3 months (p < 0.001). There was no significant difference between CD gel and control with respect to crusting, mucosal edema, infection, or granulation tissue formation. CONCLUSION:CD gel is rapidly hemostatic immediately after ESS and prevents adhesion formation, addressing two of the most common complications of sinus surgery.
RCT Entities:
BACKGROUND:Postoperative bleeding and adhesion formation are the two most common complications after endoscopic sinus surgery (ESS). Continued bleeding risks airway compromise from the inhalation of blood clots and from the aspiration of blood-stained vomitus. Additionally, adhesion formation is the most common reason for patients requiring revision surgery. This study aimed to determine the efficacy of a novel chitosan/dextran (CD) gel on hemostasis and wound healing after ESS. METHODS: A randomized controlled trial was performed involving 40 patients undergoing ESS for chronic rhinosinusitis. Immediately after surgery a baseline Boezaart Surgical Field Grading Scale was taken. Computer randomization was performed with one side receiving CD gel and the other side receiving no treatment (control). Boezaart bleeding scores were then calculated for each side every 2 minutes. Patient's endoscopic features of wound healing were assessed at 2, 6, and 12 weeks after surgery. RESULTS:CD gel achieved rapid hemostasis with the mean time to hemostasis at 2 minutes (95% CI, 2-4 minutes) compared with 10 minutes (95% CI, > or =6 minutes) for the control (p < 0.001). There were significantly less adhesions at all time points with CD gel versus control: 2 versus 18 at 2 weeks (p < 0.001), 3 versus 16 at 6 weeks (p < 0.001), and 2 versus 12 at 3 months (p < 0.001). There was no significant difference between CD gel and control with respect to crusting, mucosal edema, infection, or granulation tissue formation. CONCLUSION:CD gel is rapidly hemostatic immediately after ESS and prevents adhesion formation, addressing two of the most common complications of sinus surgery.
Authors: Manal A Aziz; Jaydee D Cabral; Heather J L Brooks; Stephen C Moratti; Lyall R Hanton Journal: Antimicrob Agents Chemother Date: 2011-10-24 Impact factor: 5.191
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