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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - Experimental | Experimental | Treatment Arm: 100 patients using Respimer® NetiFlow® solution as standard treatment for healing of nasal surgery wounds following an endoscopic ethmoidectomy as a postoperative care after ethmoid sinus surgery |
|
| B - Comparator | Active Comparator | Control Arm: 100 patients using saline solution (0.9% NaCl) as standard treatment for healing of nasal surgery wounds following an endoscopic ethmoidectomy as a postoperative care after ethmoid sinus surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | D14 meaning 14 days (plus or minus 3 days) after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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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:
Free and informed written consent
Member or beneficiary of a social security program
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ludovic LE TAILLANDIER de GABORY, MD, PhD | Coordinator Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Oto-rhino-laryngologie - Clinique Saint-Augustin | Bordeaux | Gironde | 33074 | France | ||
| Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpital Pellegrin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10472466 | Background | Homer JJ, England RJ, Wilde AD, Harwood GR, Stafford ND. The effect of pH of douching solutions on mucociliary clearance. Clin Otolaryngol Allied Sci. 1999 Aug;24(4):312-5. doi: 10.1046/j.1365-2273.1999.00265.x. | |
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|
| Pre-inclusion, D7, D14, D21 and D28 |
| Assess and compare the crusting | Assess and compare the crusting with :
| 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). | 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). | D7, D14, D21 and D28 after surgery |
| Satisfaction and perceived efficacy of the nasal solution | 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). | 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). | 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, 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). | D14, D21 and D28 |
| Bordeaux |
| Gironde |
| 33076 |
| France |
| ORL et Chirurgie Cervico-faciale - Pôle Voies Respiratoires - CHU Toulouse | Toulouse | Haute-Garonne | 31059 | France |
| Service d'ORL et Chirurgie cervico faciale - CHRU Tours | Tours | Indre-et-Loire | 37044 | France |
| Service d'oto-rhino-laryngologie - CHU de Nantes | Nantes | Loire-Atlantique | 44093 | France |
| Service ORL et Chirurgie Cervico-faciale - CHRU Nancy | Nancy | Meurthe-et-Moselle | France |
| Service ORL et Chirurgie cervico-faciale - CHRU Lille | Lille | Nord | 59037 | France |
| ORL et Chirurgie Cervico-faciale - Centre Hospitalier Intercommunal (CHI) de Créteil | Créteil | Val-de-Marne | 94010 | France |
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