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.

Full Abstract

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.

Author information

Author/s: Shoman, Nael (N); Gheriani, Heitham (H); Flamer, David (D); Javer, Amin (A);

Affiliation: St Paul Sinus Centre, Vancouver, BC, Canada.

Journal and publication information

Publication Type: Journal Article; Randomized Controlled Trial

Journal: Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale (J Otolaryngol Head Neck Surg), published in Canada. (Language: eng)

Reference: 2009-Feb; vol 38 (issue 1) : pp 112-8

Dates: Created 2009/04/06; Completed 2009/08/14;

PMID: 19344620, status: MEDLINE (last retrieved date: 8/21/2009)

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