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Completed

NCT Number: NCT02559284

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

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.

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Key information

Conditions

Polyp of Ethmoidal Sinus Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'Oto-rhino-laryngologie - Clinique Saint-Augustin, Bordeaux, Gironde, France

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About this study

This is a comparative study between two postoperative treatments following ethmoid sinus surgery. The purpose of this study is to compare the effect of RESPIMER® NetiFlow® solution on nasal tissue repair versus saline solution (0.9% NaCl), the standard treatment.

The type of surgery selected for this study is total endoscopic ethmoidectomy. This is a frequently used standard surgery that requires nasal cleansing for an average of 28 days. This process allows the regeneration of the nasal epithelial lining of the wound (areas of exposed bone), as well as the healing of swelling and scarring due to the surgery.

The follow up last 28 days with 4 visits (D7, D14, D21 and D28).

RESPIMER® NetiFlow® : device of class I, with CE mark, in the indication of sinus postoperative care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females between 18 and 65 years of age
  • Subject in need of sinus surgery as bilateral total ethmoidectomy using an endoscopic endonasal approach whose pathology is the result of a:
  • Sinonasal polyposis alone
  • Sinonasal polyposis associated with asthma and / or intolerance to NSAIDs
  • Free and informed written consent
  • Member or beneficiary of a social security program

Exclusion criteria

  • Oral corticosteroid treatment since less than 2 months
  • Premenopausal women not using effective contraception (oral or intrauterine device)
  • Pregnant or nursing women
  • Uncontrolled diabetes (not treated or stabilized by treatment)
  • HIV-positive status
  • Autoimmune diseases affecting the nose and/or sinuses, immune dysfunctions (Wegener's granulomatosis, Churg-Strauss syndrome, Common Variable Immunodeficiency, sarcoidosis...), or malignant diseases (unclear histology)
  • All contraindication of RESPIMER® NetiFlow®
  • All diseases resulting in difficulty coughing or swallowing
  • Ongoing or past radiation treatment to the head and neck
  • Ongoing or recent chemotherapy (within a three-month period)
  • Subjects using anticoagulants
  • Subjects taking part in another study that includes an exclusion period coinciding with that of the run-in period of this study
  • Subjects placed under judicial protection
  • Subjects who suffer from severe physical or psychological problems and whose condition can, according to the investigator, affect compliance with the study

Treatment and study plan

A postoperative care after ethmoid sinus surgery

Other

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).

Primary outcomes

  1. Superior healing of nasal mucosa repair 14 days following endoscopic sinus surgery, between the RESPIMER® NetiFlow® solution and the saline solution arms

    Time frame: D14 meaning 14 days (plus or minus 3 days) after surgery

    Based on a ≥8 points difference in the total RHINO QoL score between the two groups.

Secondary outcomes

  1. Efficacy in optimizing airway clearance and restoring respiratory health, as well as overall quality of life

    Time frame: Pre-inclusion, D7, D14, D21 and D28

    Compare the efficacy of RESPIMER® NetiFlow® versus saline solutions in optimizing airway clearance and restoring respiratory health, as well as overall quality of life using:

    • RHINO QoL scores (a self-report of nasal congestion, facial pain, anterior and posterior rhinorrhea).
    • NOSE nasal obstruction scores.

  2. Assess and compare the crusting

    Time frame: Pre-inclusion, D7, D14, D21 and D28

    Assess and compare the crusting with :

    • The number of patients with (whether or not obstruction exists) and without crusting.
    • How many days it takes for the crusting to disappear and/or the difference in the total number of care days

  3. Assess and compare the tolerability

    Time frame: Pre-inclusion, D7, D14, D21 and D28

    Assess and compare the tolerability of RESPIMER® NetiFlow® versus saline solutions using a Visual Analog Scale (VAS) (burning sensation in the nose, alterations in taste and smell and epistaxis) (patient record).

  4. Additional details on duration of nasal washes

    Time frame: D7, D14, D21 and D28 after surgery

    Provide additional details on the duration of nasal washes according to the approved indication (patient record).

  5. Satisfaction and perceived efficacy of the nasal solution

    Time frame: D7, D14, D21 and D28 after surgery

    VAS numerical values assessing the level of patient satisfaction and perceived efficacy in regard to the nasal solution that was used by each group (patient's Case report Form).

  6. Satisfaction, convenience, ease of administration and ease of cleaning of the RESPIMER® NetiFlow® device

    Time frame: D7, D14, D21 and D28 after surgery

    VAS numerical values assessing the RESPIMER® NetiFlow® device in terms of satisfaction, convenience, ease of administration and ease of cleaning (patient's Case report Form).

  7. Assess functionality of nasal lining

    Time frame: D-1, D14, and D21

    Assess functionality of nasal lining by evaluating mucociliary clearance by rhinoscintigraphy for all patients in the 2 Bordeaux centers' (Bordeaux University Hospital and Saint-Augustin Private Hospital):

    • D-1 only for center's Bordeaux, 10 patients in each group (20 patients in total)
    • D14 and D21 for all Bordeaux patients', estimated at 50 patients (15 in each group and in addition the same 10 patients of the D-1 visit, in each group).

  8. Efficacy in improving the trophicity of the nasal mucosa within the operated area

    Time frame: D14, D21 and D28

    Assess the efficacy of RESPIMER® NetiFlow® versus saline solutions in improving the trophicity of the nasal mucosa within the operated area, using a Lund-Kennedy endoscopic score (20 points).

Sponsors and collaborators

Lead sponsor

Laboratoire de la Mer

Industry

Registry information

Official study title

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.

Acronym: NETIFLOW

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 24, 2015
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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