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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
189
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).
Service d'Oto-rhino-laryngologie - Clinique Saint-Augustin
Bordeaux, Gironde, France
Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpital Pellegrin
Bordeaux, Gironde, France
ORL et Chirurgie Cervico-faciale - Pôle Voies Respiratoires - CHU Toulouse
Toulouse, Haute-Garonne, France
Superior healing of nasal mucosa repair 14 days following endoscopic sinus surgery, between the RESPIMER® NetiFlow® solution and the saline solution arms
Based on a ≥8 points difference in the total RHINO QoL score between the two groups.
Time frame: D14 meaning 14 days (plus or minus 3 days) after surgery
Efficacy in optimizing airway clearance and restoring respiratory health, as well as overall quality of life
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.
Time frame: Pre-inclusion, D7, D14, D21 and D28
Assess and compare the crusting
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
Time frame: Pre-inclusion, D7, D14, D21 and D28
Assess and compare the tolerability
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).
Time frame: Pre-inclusion, D7, D14, D21 and D28
Additional details on duration of nasal washes
Provide additional details on the duration of nasal washes according to the approved indication (patient record).
Time frame: D7, D14, D21 and D28 after surgery
Satisfaction and perceived efficacy of the nasal solution
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Service d'ORL et Chirurgie cervico faciale - CHRU Tours
Tours, Indre-et-Loire, France
Service d'oto-rhino-laryngologie - CHU de Nantes
Nantes, Loire-Atlantique, France
Service ORL et Chirurgie Cervico-faciale - CHRU Nancy
Nancy, Meurthe-et-Moselle, France
Service ORL et Chirurgie cervico-faciale - CHRU Lille
Lille, Nord, France
ORL et Chirurgie Cervico-faciale - Centre Hospitalier Intercommunal (CHI) de Créteil
Créteil, Val-de-Marne, France
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).
Time frame: D7, D14, D21 and D28 after surgery
Satisfaction, convenience, ease of administration and ease of cleaning of the RESPIMER® NetiFlow® device
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).
Time frame: D7, D14, D21 and D28 after surgery
Assess functionality of nasal lining
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).
Time frame: D-1, D14, and D21
Efficacy in improving the trophicity of the nasal mucosa within the operated area
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).
Time frame: D14, D21 and D28