RESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy (Nasal Polyposis)
- Conditions
- SurgeryPolyp of Ethmoidal Sinus
- Interventions
- Other: A postoperative care after ethmoid sinus surgery
- Registration Number
- NCT02559284
- Lead Sponsor
- Laboratoire de la Mer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 189
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A - Experimental A postoperative care after ethmoid sinus surgery 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 A postoperative care after ethmoid sinus surgery 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
- Primary Outcome Measures
Name Time Method Superior healing of nasal mucosa repair 14 days following endoscopic sinus surgery, between the RESPIMER® NetiFlow® solution and the saline solution arms 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 Outcome Measures
Name Time Method Efficacy in optimizing airway clearance and restoring respiratory health, as well as overall quality of life 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.Additional details on duration of nasal washes D7, D14, D21 and D28 after surgery Provide additional details on the duration of nasal washes according to the approved indication (patient record).
Satisfaction, convenience, ease of administration and ease of cleaning of the RESPIMER® NetiFlow® device 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).
Assess and compare the tolerability 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).
Assess functionality of nasal lining 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).Assess and compare the crusting 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 daysSatisfaction and perceived efficacy of the nasal solution 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).
Efficacy in improving the trophicity of the nasal mucosa within the operated area 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).
Trial Locations
- Locations (8)
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 cedex 9, Haute-Garonne, France
Service d'ORL et Chirurgie cervico faciale - CHRU Tours
🇫🇷Tours cedex 1, Indre-et-Loire, France
Service d'oto-rhino-laryngologie - CHU de Nantes
🇫🇷Nantes Cedex 1, Loire-Atlantique, France
Service ORL et Chirurgie Cervico-faciale - CHRU Nancy
🇫🇷Nancy CEDEX, Meurthe-et-Moselle, France
Service ORL et Chirurgie cervico-faciale - CHRU Lille
🇫🇷Lille cedex, Nord, France
ORL et Chirurgie Cervico-faciale - Centre Hospitalier Intercommunal (CHI) de Créteil
🇫🇷Créteil cedex, Val-de-Marne, France
Service d'Oto-rhino-laryngologie - Clinique Saint-Augustin🇫🇷Bordeaux, Gironde, France