Clinical trial NCT02559284: RESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy (Nasal Polyposis)
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyp of Ethmoidal Sinus
Surgery
Keywords: Saline Solution, Isotonic / Administration & dosage
Therapeutic Irrigation / methods
Postoperative Care / methods
Quality of life
Lead sponsor: Laboratoire de la Mer
Sponsor class: INDUSTRY
First posted: 2015-09-24
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Superior healing of nasal mucosa repair 14 days following endoscopic sinus surgery, between the RESPIMER® NetiFlow® solution and the saline solution arms
timeFrame: D14 meaning 14 days (plus or minus 3 days) after surgery
Secondary outcomes:
measure: Efficacy in optimizing airway clearance and restoring respiratory health, as well as overall quality of life
timeFrame: Pre-inclusion, D7, D14, D21 and D28
measure: Assess and compare the crusting
timeFrame: Pre-inclusion, D7, D14, D21 and D28
measure: Assess and compare the tolerability
timeFrame: Pre-inclusion, D7, D14, D21 and D28
measure: Additional details on duration of nasal washes
timeFrame: D7, D14, D21 and D28 after surgery
measure: Satisfaction and perceived efficacy of the nasal solution
timeFrame: D7, D14, D21 and D28 after surgery
measure: Satisfaction, convenience, ease of administration and ease of cleaning of the RESPIMER® NetiFlow® device
timeFrame: D7, D14, D21 and D28 after surgery
measure: Assess functionality of nasal lining
timeFrame: D-1, D14, and D21
measure: Efficacy in improving the trophicity of the nasal mucosa within the operated area
timeFrame: D14, D21 and D28
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service d'Oto-rhino-laryngologie - Clinique Saint-Augustin
state: Gironde
city: Bordeaux
country: France
facility: Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpital Pellegrin
state: Gironde
city: Toulouse cedex 9
country: France
facility: ORL et Chirurgie Cervico-faciale - Pôle Voies Respiratoires - CHU Toulouse
state: Haute-Garonne
city: Tours cedex 1
country: France
facility: Service d'ORL et Chirurgie cervico faciale - CHRU Tours
state: Indre-et-Loire
city: Nantes Cedex 1
country: France
facility: Service d'oto-rhino-laryngologie - CHU de Nantes
state: Loire-Atlantique
city: Nancy CEDEX
country: France
facility: Service ORL et Chirurgie Cervico-faciale - CHRU Nancy
state: Meurthe-et-Moselle
city: Lille cedex
country: France
facility: Service ORL et Chirurgie cervico-faciale - CHRU Lille
state: Nord
city: Créteil cedex
country: France
facility: ORL et Chirurgie Cervico-faciale - Centre Hospitalier Intercommunal (CHI) de Créteil
state: Val-de-Marne
Study officials:
affiliation: Coordinator Investigator
name: Ludovic LE TAILLANDIER de GABORY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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