CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 189 enrolled
Drug / intervention
A postoperative care after ethmoid sinus surgeryother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02559284
NCT02559284N/ACompleted

A Comparative, Multicenter and Randomized Study Evaluating the Safety and Efficacy of RESPIMER® Netiflow® Versus Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy in the Treatment of Nasal Polyposis.

Laboratoire de la Mer·interventional·Posted Sep 24, 2015·Updated Sep 1, 2017

In Brief

A clinical study evaluating A postoperative care after ethmoid sinus surgery for Polyp of Ethmoidal Sinus and Surgery. Completed, enrolled 189 participants across 8 sites.

Detailed Summary

The main objective of this study is to compare the effects of RESPIMER® NetiFlow® solution and device versus saline solution (0.9% NaCl), the standard treatment, used with RESPIMER® NetiFlow® device, both used postoperative care, in the context of ethmoid sinus surgery, at 14 days post-surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 24, 2015
Enrollment StartApr 1, 2015
Primary CompletionFeb 1, 2017
Study CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.8 years ago

Interventions

A postoperative care after ethmoid sinus surgeryother

A comparison of two products used for nasal cavity cleansing, at the rate of 4 washes/day (240mL per wash), as local postoperative care following endoscopic sinus surgery. This surgery, known as an ethmoidectomy, aims to improve sinus ventilation, treat the chronically infected area, and remove polyps that cause nasal obstruction. Detailed information concerning the purpose of nasal irrigation, as well as how to use and clean the device, will be given to patients upon inclusion. The nasal washing procedure will be as follow: * Washing both nostrils using 180mL of solution distributed equally on each side to remove crusting and clotting * Gentle blowing of the nose * Rinsing both nostrils with the remaining 60mL of solution distributed equally on each side (no nose-blowing).