Surgery Clinical Trial
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.
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.
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.
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