Back to resultsRESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy (Nasal Polyposis) (NETIFLOW)
Primary Purpose
Polyp of Ethmoidal Sinus, Surgery
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
A postoperative care after ethmoid sinus surgery
Sponsored by
About this trial
This is an interventional other trial for Polyp of Ethmoidal Sinus focused on measuring Saline Solution, Isotonic / Administration & dosage, Therapeutic Irrigation / methods, Postoperative Care / methods, Quality of life
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
Sites / Locations
- Service d'Oto-rhino-laryngologie - Clinique Saint-Augustin
- Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpital Pellegrin
- ORL et Chirurgie Cervico-faciale - Pôle Voies Respiratoires - CHU Toulouse
- Service d'ORL et Chirurgie cervico faciale - CHRU Tours
- Service d'oto-rhino-laryngologie - CHU de Nantes
- Service ORL et Chirurgie Cervico-faciale - CHRU Nancy
- Service ORL et Chirurgie cervico-faciale - CHRU Lille
- ORL et Chirurgie Cervico-faciale - Centre Hospitalier Intercommunal (CHI) de Créteil
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A - Experimental
B - Comparator
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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).
Additional details on duration of nasal washes
Provide additional details on the duration of nasal washes according to the approved indication (patient record).
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).
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).
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).
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).
Full Information
NCT ID
NCT02559284
First Posted
September 22, 2015
Last Updated
August 31, 2017
Sponsor
Laboratoire de la Mer
1. Study Identification
Unique Protocol Identification Number
NCT02559284
Brief Title
RESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy (Nasal Polyposis)
Acronym
NETIFLOW
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoire de la Mer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyp of Ethmoidal Sinus, Surgery
Keywords
Saline Solution, Isotonic / Administration & dosage, Therapeutic Irrigation / methods, Postoperative Care / methods, Quality of life
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A - Experimental
Arm Type
Experimental
Arm Description
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
Arm Title
B - Comparator
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
A postoperative care after ethmoid sinus surgery
Intervention Description
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 Outcome Measure Information:
Title
Superior healing of nasal mucosa repair 14 days following endoscopic sinus surgery, between the RESPIMER® NetiFlow® solution and the saline solution arms
Description
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
Secondary Outcome Measure Information:
Title
Efficacy in optimizing airway clearance and restoring respiratory health, as well as overall quality of life
Description
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
Title
Assess and compare the crusting
Description
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
Title
Assess and compare the tolerability
Description
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
Title
Additional details on duration of nasal washes
Description
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
Title
Satisfaction and perceived efficacy of the nasal solution
Description
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
Title
Satisfaction, convenience, ease of administration and ease of cleaning of the RESPIMER® NetiFlow® device
Description
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
Title
Assess functionality of nasal lining
Description
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
Title
Efficacy in improving the trophicity of the nasal mucosa within the operated area
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ludovic LE TAILLANDIER de GABORY, MD, PhD
Organizational Affiliation
Coordinator Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Oto-rhino-laryngologie - Clinique Saint-Augustin
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33074
Country
France
Facility Name
Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpital Pellegrin
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Facility Name
ORL et Chirurgie Cervico-faciale - Pôle Voies Respiratoires - CHU Toulouse
City
Toulouse cedex 9
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Service d'ORL et Chirurgie cervico faciale - CHRU Tours
City
Tours cedex 1
State/Province
Indre-et-Loire
ZIP/Postal Code
37044
Country
France
Facility Name
Service d'oto-rhino-laryngologie - CHU de Nantes
City
Nantes Cedex 1
State/Province
Loire-Atlantique
ZIP/Postal Code
44093
Country
France
Facility Name
Service ORL et Chirurgie Cervico-faciale - CHRU Nancy
City
Nancy CEDEX
State/Province
Meurthe-et-Moselle
Country
France
Facility Name
Service ORL et Chirurgie cervico-faciale - CHRU Lille
City
Lille cedex
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
ORL et Chirurgie Cervico-faciale - Centre Hospitalier Intercommunal (CHI) de Créteil
City
Créteil cedex
State/Province
Val-de-Marne
ZIP/Postal Code
94010
Country
France
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RESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy (Nasal Polyposis)
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