Clinical trial NCT01420471: Medicated Punctured-Glove-Finger Spacer Study
Official title: Medicated Punctured-Glove-Finger Spacer Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sinusitis
Keywords: Endoscopic Sinus Surgery
Triamcinolone
Merocel Middle Meatus Spacers
Lead sponsor: St. Paul's Hospital, Canada
Sponsor class: OTHER
First posted: 2011-08-19
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Patients suffering from chronic rhinosinusitis undergoing Functional Endoscopic Sinus Surgery (FESS) require nasal spacers to be inserted intra-operatively into the middle-meatus to prevent lateralization of the middle turbinate and subsequent scarring and adhesions. Nasal spacers can be impregnated with topical steroids to assist in post-surgical recovery. Our centre is now investigating the effect of triamcinolone-medicated nasal spacers placed inside a punctured glove finger to improve wound healing.

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. One nostril will receive the experimental treatment (Triamcinolone-impregnated spacer) and one will receive the control treatment (Saline-impregnated spacer). These spacers will be removed after 6-days post-op.

Randomization of patients' nostrils to a treatment arm will occur on the day of surgery based on a closed envelope system.

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. The 14-day follow-up appointment is an additional visit not included as standard practice at our centre. However, study patients will have this added visit in order to closely observe their recovery and endoscopic evaluation. During these appointments, the surgeon will assess the post-operative appearance (Philpott-Javer Sinus Rating System), number of infections, pain, and 1st week post-operative bleeding (only at 6 day visit).

The Sino-Nasal Outcome Test (SNOT-22) questionnaire is to be completed by the study participants at 6 days, 14 days, 5 weeks, and 3 months of the post-operative period. The SNOT-22 is a 5-minute questionnaire consisting of 22 questions, which asks participants to rate their sinus symptoms and social/emotional consequences of their nasal disorder from "no problem" to "problem as bad as it can be."

Sinus tissue biopsies will also be taken from both meati intraoperatively (standard of care) and on 28-day and 3-month post-op follow-up appointments (above standard of care). Biopsies will be sent to a pathologist for grading on a scale of tissue inflammation. To grade the level of mucosal inflammation in an objective fashion, the pathologist has previously devised a grading system on a scale from 0 to 4. A score of 0 is given for normal tissue, 1 for submucosal inflammation with no inflammatory infiltrate into the epithelium, 2 for inflammatory infiltrate with neutrophils into the epithelium with no evidence of necrosis, 3 for inflammatory infiltrate with neutrophils into the epithelium with evidence of focal necrosis and 4 for inflammatory infiltrate with neutrophils into the epithelium with evidence of extensive necrosis (5).

Eligibility criteria: Inclusion Criteria:

* All CRS patients undergoing bilateral endoscopic surgery requiring spacers

Exclusion Criteria:

* Patients under the age of 19
* Patients unable to understand English
* Patients who are pregnant
* Patients with known bleeding disorders
* Patients with systemic disorders affecting the nose
* Patients in another concurrent study
* Unilateral endoscopic sinus surgery
* Surgery in which spacers are not needed
* Patients undergoing sinonasal tumour resection
* Patients who cannot tolerate or are allergic to triamcinolone

Primary outcomes:
measure: Post-operative endoscopic appearance
timeFrame: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
measure: Post-operative inflammation
timeFrame: Biopsies will be removed during a 3 month period (beginning the day of surgery)
Secondary outcomes:
measure: Post-Operative SNOT-22
timeFrame: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: E.N.T. Clinic, St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: St. Paul's Hospital, Canada
name: Amin R Javer, MD, FRCSC,FARS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.