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Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery

NCT02077322 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-04-20

No results posted yet for this study

Summary

Functional endoscopic sinus surgery (FESS) is the best method of surgically treating patients who suffer from sinus disease. Synechiae formation in the nose is the most common complication after sinus surgery. Synechiae describes the adhesion of two opposing mucosal surfaces in the nasal cavity that can cause scarring and obstruction of the nasal passage. Spacers are often inserted during surgery between nasal mucosal surfaces to prevent synechiae. The aim of this study is to see if a silastic spacer is more effective at reducing the formation of synechiae after sinus surgery than a merocel spacer.

Conditions

  • Sinusitis

Interventions

DEVICE

Silastic Spacer

The Silastic 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 to 14 days following surgery.

DEVICE

Merocel Spacer

The Merocel 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 to 14 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
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-05-31
Completion
2017-05-31

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 NCT02077322 on ClinicalTrials.gov