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.

Original article


Shoman N, Gheriani H, Flamer D, Javer A.

St Paul Sinus Centre, Vancouver, BC, Canada.

J Otolaryngol Head Neck Surg. 2009 Feb;38(1):112-8.


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.

Keywords: 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