Medicated Punctured-Glove-Finger Spacer Study

Summary

All adult patients undergoing sinus surgery for chronic rhinosinusitis (CRS) that satisfy the inclusion/exclusion criteria will be included in the study. All patients enrolled in this study will have spacers (impregnated with saline or Triamcinolone) inserted into their middle meati after sinus surgery. Patients will serve as their own controls. Nostril's will be randomized to either the experimental treatment (Triamcinolone-impregnated spacer) or the control treatment (Saline-impregnated spacer). These spacers will be removed after 6-days post-op. Participants will undergo the standard post-operative endoscopic sinus surgery follow-up appointments plus one additional research visit (not standard of care). This includes follow-up appointments at 6 days, 14 days, 5 weeks, 3 months, and 6 months of the post-operative period. During these appointments, the surgeon will assess the post-operative mucosal appearance (Philpott-Javer Sinus Rating System). SNOT-22 surveys will be administered, as per standard protocol, at each post-op follow up visit. Sinus tissue biopsies will be taken from both meati on 28-day and 3-month post-op follow-up appointments for analysis. Our objective is to determine if triamcinolone soaked Merocel middle meatus spacers (MMS) in a perforated glove finger improves patient outcomes, wound healing and reduces inflammation compared to a standard saline-soaked merocel sponge within a perforated glove finger in CRS patients receiving FESS. Our hypothesis is that triamcinolone-medicated Merocel MMS are not inferior to standard saline-soaked spacers, when both are enclosed in a perforated surgical glove finger.

Timeline

Start

2011-09

Primary completion

2012-05

Completion

2012-06

Publications

• Background Desrosiers M, Hussain A, Frenkiel S, Kilty S, Marsan J, Witterick I, Wright E. Intranasal corticosteroid use is associated with lower rates of bacterial recovery in chronic rhinosinusitis. Otolaryngol Head Neck Surg. 2007 Apr;136(4):605-9. doi: 10.1016/j.otohns.2006.10.028.
• Results Chang EH, Alandejani T, Akbari E, Ostry A, Javer A. Double-blinded, randomized, controlled trial of medicated versus nonmedicated merocel sponges for functional endoscopic sinus surgery. J Otolaryngol Head Neck Surg. 2011 Feb;40 Suppl 1:S14-9.
• Results Shoman N, Gheriani H, Flamer D, Javer A. 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. J Otolaryngol Head Neck Surg. 2009 Feb;38(1):112-8.
• Results Franklin JH, Wright ED. Randomized, controlled, study of absorbable nasal packing on outcomes of surgical treatment of rhinosinusitis with polyposis. Am J Rhinol. 2007 Mar-Apr;21(2):214-7. doi: 10.2500/ajr.2007.21.3011.

Drugs

Indications