RESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectom… (NCT02559284) | Clinical Trial Compass
CompletedNot Applicable
RESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy (Nasal Polyposis)
France189 participantsStarted 2015-04
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Superior healing of nasal mucosa repair 14 days following endoscopic sinus surgery, between the RESPIMER® NetiFlow® solution and the saline solution arms
Timeframe: D14 meaning 14 days (plus or minus 3 days) after surgery