RESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy (Nasal Polyposis) (NETIFLOW)

Laboratoire de la Mer

Status: Completed

Conditions: Surgery; Polyp of Ethmoidal Sinus

Treatments: Other: A postoperative care after ethmoid sinus surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT02559284

P0013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 189 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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189 participants in 2 patient groups

A - Experimental

Experimental group

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

Treatment:

Other: A postoperative care after ethmoid sinus surgery

B - Comparator

Active Comparator group

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

Treatment:

Other: A postoperative care after ethmoid sinus surgery