MedTrace Logo

Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery

NCT02627794 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-11-17

Study results available
· View outcomes & findings →

Summary

Endoscopic sinus surgery (ESS) is the gold standard surgical intervention for chronic rhinosinusitis that is not adequately controlled with maximal medical therapy.

In some patients, underlying inflammation (discharge, edema and polyposis), compounded by inflammation caused by surgical trauma may lead to an uncontrolled healing response, which results in the synechiae formation in the middle meatus (MM).

Incidence of synechiae formation varies in literature and ranges between 4-35%. Presence of middle meatal synechiae can impair sinus drainage, promote sinusitis, and limit endoscopic visualization of the sinus cavities postoperatively. This may result in difficulty in performing postoperative routine endoscopic debridement and examination, which is paramount to a successful outcome from ESS. Spacers are often inserted during surgery between nasal mucosal surfaces to prevent synechiae.

The aim of this study is to see if a steroid-impregnated spacer is more effective at reducing inflammation after sinus surgery than a Silastic spacer.

Conditions

  • Sinusitis

Interventions

DEVICE

Restora™ Steroid eluting spacer

The Restora™ Steroid eluting spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery.

DEVICE

Silastic Silicone Spacer

The Silastic Silicone Spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery.

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Martin L Hopp, MD · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT02627794 on ClinicalTrials.gov