Prospective, Double-Blind, Randomized Trial Evaluating Patient Satisfaction, Bleeding, and Wound Healing Using Biodegradable Synthetic Polyurethane Foam (NasoPore) as a Middle Meatal Spacer in Functional Endoscopic Sinus Surgery

Shoman, Nael; Gheriani, Heitham; Flamer, David; Javer, Amin
February 2009
Journal of Otolaryngology -- Head & Neck Surgery;Feb2009, Vol. 38 Issue 1, p112
Academic Journal
Objective: To compare NasoPore (Stryker Canada, Hamilton, ON, Canada) and a traditional middle meatal spacer (MMS) composed of Merocel ((Medtronic Xomed, Mississauga, ON, Canada) placed in a vinyl glove finger in functional endoscopic sinus surgery (FESS) with regard to postoperative bleeding, wound healing, and patient comfort. Design: A prospective, double-blind, randomized trial of 30 consecutive adults (age > 16 years) with chronic or recurrent acute rhinosinusitis undergoing bilateral FESS, excluding patients with significant difference in their sinus disease bilaterally using preoperative computed tomographic scan assessment (Lund-McKay scores > 2). Setting: Tertiary hospital, Vancouver, British Columbia. Methods: Preoperatively, all patients were randomized and blinded to receive NasoPore (Stryker Canada) on one side and Merocel on the other. Patients completed a questionnaire during their first postoperative week relating to their subjective assessment of pain, pressure, nasal blockage, swelling, and bleeding. Patients were evaluated 1 week postoperatively for packing removal and debridement, and associated discomfort and bleeding with the removal, as well as overall preference for either pack. A clinician blinded to the randomization process objectively assessed the healing status of the nasal cavities at 4 and 12 weeks postoperatively. Main Outcome Measures: Patient satisfaction, bleeding, and wound healing postoperatively. Results: Thirty patients were enrolled. There was no significant difference between the Lund-Mackay scores in both groups preoperatively (p = .80). Postoperatively, there was no significant difference between both groups with regard to patients' pain, pressure, blockage, swelling, bleeding, or discomfort on packing removal (p > .05). There was no statistical difference in the amount of bleeding associated with packing removal (p = .32). Mucosal grading at 4 weeks was significantly better for the traditional MMS (p = .03), but this difference disappeared at the 12-week visit (p = 1.00). Conclusions: The absorbable pack did not significantly reduce the risk of bleeding or patient discomfort compared with a traditional nonabsorbable MMS and was associated with significantly slower mucosal healing initially, an effect that disappeared after 3 months postoperatively. There was no significant patient preference for either pack.


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