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RESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy (Nasal Polyposis)

NCT02559284 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2017-09-01

No results posted yet for this study

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.

Conditions

  • Polyp of Ethmoidal Sinus
  • Surgery

Interventions

OTHER

A postoperative care after ethmoid sinus surgery

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).

Sponsors & Collaborators

  • Laboratoire de la Mer

    lead INDUSTRY

Principal Investigators

  • Ludovic LE TAILLANDIER de GABORY, MD, PhD · Coordinator Investigator

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-02-28
Completion
2017-05-31

Countries

  • France

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 NCT02559284 on ClinicalTrials.gov