4.4 Article

Silver sucrose octasulfate nasal applications and wound healing after endoscopic sinus surgery: a prospective, randomized, double-blind, placebo-controlled study

Journal

AMERICAN JOURNAL OF OTOLARYNGOLOGY
Volume 36, Issue 5, Pages 625-631

Publisher

W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1016/j.amjoto.2015.02.014

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Funding

  1. Interalia S.r.l., Padova, Italy

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Objectives: The aim of the present prospective, randomized, double-blind, and placebo-controlled investigation (approved by the Ethical Committee of Padova University Hospital [Italy]) was to assess the effect of a nasal gel containing a combination of silver sucrose octasulfate and potassium sucrose octasulfate (Silsos gel (R) [SG]) in wound healing after endoscopic sinus surgery (ESS) for chronic rhinosinusitis in terms of: nasal symptoms (SNOT22), endoscopic appearance of the sinonasal mucosa (Lund-Kennedy score), nasal air flow (anterior active rhinomanometry), evidence of mucosal inflammatory processes (nasal cytology and histology), and microbiological growth. Methods: Thirty-four patients with chronic rhinosinusitis were randomized on a 1:1 ratio to receive after ESS either SG or placebo (contained only the excipients [carbopol and propylene glycol] in the same concentrations as in SG). Results/conclusions: Judging from the present prospective investigation on patients who underwent ESS for chronic rhinosinusitis, treatment with SG seems to enable a significantly faster improvement in specific symptoms (assessed on the validated SNOT22 scale) than placebo. Patients treated with SG also had a quicker improvement in the endoscopic appearance of their nasal mucosa after ESS than patients treated with placebo. These endoscopic improvements in the SG group were also confirmed at the long-term follow-up, while the same did not apply to the placebo-treated group. (C) 2015 Elsevier Inc. All rights reserved.

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