Medicated Punctured-Glove-Finger Spacer Study

NCT01420471 | Completed Phase 4

• 1 other identifier: FISHNET-2011
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinusitis

Keywords

Endoscopic Sinus Surgery; Triamcinolone; Merocel Middle Meatus Spacers

Outcome Measures

Primary Outcomes (2)

• Post-operative endoscopic appearance

  Participants in the study have their sinus cavities assessed by rigid endoscopy and mucosa graded by the Lund-Kennedy and Philpott-Javer scaling system. Each sinus cavity (frontal, ethmoid, maxillary and sphenoid) and olfactory cleft will be given a score between zero and nine, with an extra point for the presence of fungal mucin, achieving a total potential maximum out of fifty per side (14).

  Participants will be followed for the duration of post op standard of care, an expected average of 6 months.

• Post-operative inflammation

  Participants will have biopsies taken from both middle meati in contact with nasal packing. Biopsies will be assessed and scored with a previously utilized histologic scoring system at our centre in order to determine the level of inflammation between the triamcinolone-medicated and saline-soaked spacers.

  Biopsies will be removed during a 3 month period (beginning the day of surgery)

Secondary Outcomes (1)

• Post-Operative SNOT-22

  Participants will be followed for the duration of post op standard of care, an expected average of 6 months.

Study Arms (2)

Saline-impregnated spacer

ACTIVE COMPARATOR

Saline-impregnated spacers are actively being used as the standard of care. It does not contain any active ingredients.

Other: Saline-impregnated spacer

Triamcinolone-impregnated spacer

EXPERIMENTAL

This study arm receives the experimental treatment, a Triamcinolone-impregnated spacer.

Drug: Triamcinolone

Interventions

Triamcinolone DRUG

Spacer will be impregnated with 2mL of Triamcinolone. The triamcinolone-impregnated spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6 days following surgery.

Also known as: Triamcinolone-impregnated Middle Meatus Spacer, Experimental treatment, Endoscopic Sinus Surgery

Triamcinolone-impregnated spacer

Saline-impregnated spacer OTHER

Spacer will be impregnated with 2mL of Saline solution. The saline-impregnated spacer will be inserted into the middle meatal space intraoperatively. The spacer will be left in the middle meatus for a period of 6 days following surgery.

Also known as: Saline-impregnated middle meatal spacer, Endoscopic sinus surgery, Control

Saline-impregnated spacer

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All CRS patients undergoing bilateral endoscopic surgery requiring spacers

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

Study Sites (1)

E.N.T. Clinic, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (4)

• 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.

  PMID: 17418259 BACKGROUND

• 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.

  PMID: 21453656 RESULT

• 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.

  PMID: 19344620 RESULT

• 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.

  PMID: 17424883 RESULT

MeSH Terms

Conditions

Sinusitis

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Amin R Javer, MD, FRCSC,FARS

  St. Paul's Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCSC FARS

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 19, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

CA (1)