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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Laboratoire de la Mer
- Enrollment
- 189
- Locations
- 15
- Primary Endpoint
- Superior healing of nasal mucosa repair 14 days following endoscopic sinus surgery, between the RESPIMER® NetiFlow® solution and the saline solution arms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A - 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
Intervention: A postoperative care after ethmoid sinus surgery (Other)
B - 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
Intervention: A postoperative care after ethmoid sinus surgery (Other)
Outcomes
Primary Outcomes
Superior healing of nasal mucosa repair 14 days following endoscopic sinus surgery, between the RESPIMER® NetiFlow® solution and the saline solution arms
Time Frame: 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 Outcomes
- Efficacy in optimizing airway clearance and restoring respiratory health, as well as overall quality of life(Pre-inclusion, D7, D14, D21 and D28)
- Additional details on duration of nasal washes(D7, D14, D21 and D28 after surgery)
- Satisfaction, convenience, ease of administration and ease of cleaning of the RESPIMER® NetiFlow® device(D7, D14, D21 and D28 after surgery)
- Assess and compare the tolerability(Pre-inclusion, D7, D14, D21 and D28)
- Assess functionality of nasal lining(D-1, D14, and D21)
- Assess and compare the crusting(Pre-inclusion, D7, D14, D21 and D28)
- Satisfaction and perceived efficacy of the nasal solution(D7, D14, D21 and D28 after surgery)
- Efficacy in improving the trophicity of the nasal mucosa within the operated area(D14, D21 and D28)