Medicated Punctured-Glove-Finger Spacer Study
Information source: St. Paul's Hospital, Canada
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sinusitis
Intervention: Triamcinolone (Drug); Saline-impregnated spacer (Other)
Phase: Phase 4
Status: Completed
Sponsored by: St. Paul's Hospital, Canada Official(s) and/or principal investigator(s): Amin R Javer, MD, FRCSC,FARS, Principal Investigator, Affiliation: St. Paul's Hospital, Canada
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.
Clinical Details
Official title: Medicated Punctured-Glove-Finger Spacer Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Post-operative endoscopic appearancePost-operative inflammation
Secondary outcome: Post-Operative SNOT-22
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
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
E.N.T. Clinic, St. Paul's Hospital, Vancouver, British Columbia V6Z 1Y6, Canada
Additional Information
Related publications: 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.
Starting date: September 2011
Last updated: October 26, 2012
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