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Medicated Punctured-Glove-Finger Spacer Study

NCT01420471 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-10-30

No results posted yet for this 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.

Conditions

  • Sinusitis

Interventions

DRUG

Triamcinolone

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.

OTHER

Saline-impregnated spacer

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.

Sponsors & Collaborators

  • St. Paul's Hospital, Canada

    lead OTHER

Principal Investigators

  • Amin R Javer, MD, FRCSC,FARS · St. Paul's Hospital, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01420471 on ClinicalTrials.gov