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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.

AbstractOBJECTIVE:
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.
AuthorsNael Shoman, Heitham Gheriani, David Flamer, Amin Javer
JournalJournal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale (J Otolaryngol Head Neck Surg) Vol. 38 Issue 1 Pg. 112-8 (Feb 2009) ISSN: 1916-0216 [Electronic] England
PMID19344620 (Publication Type: Journal Article, Randomized Controlled Trial)
Chemical References
  • Polyurethanes
  • polyurethane foam
Topics
  • Absorbable Implants
  • Adult
  • Double-Blind Method
  • Endoscopy (methods)
  • Female
  • Hemorrhage
  • Humans
  • Male
  • Middle Aged
  • Paranasal Sinus Diseases (diagnostic imaging, therapy)
  • Patient Satisfaction
  • Polyurethanes (therapeutic use)
  • Preoperative Care
  • Prospective Studies
  • Tomography, X-Ray Computed
  • Wound Healing

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