Povidone-Iodine Rinses as an Adjuvant Therapy Post-Operatively: A Double-Blind Randomized Controlled Trial

Background and scientific rationale Chronic rhinosinusitis (CRS) is an inflammatory condition of the paranasal sinuses affecting millions of patients, resulting in billions of dollars being spent annually in associated health care costs. Biofilm has been implicated in chronic rhinosinusitis recalcitrant to appropriate medical therapy and well-executed endoscopic sinus surgery. The presence of biofilm results in patients having worse postoperative symptoms, recurrent infections, and persistent inflammation. Biofilms are bacterial or fungi communities surrounded by an extracellular polysaccharide matrix, which facilitates attachment to mucosa, survival, protection and proliferation. This configuration allows for resistance to innate host defenses and resistance to antibiotic therapy.

Iodine bound to the synthetic carrier polymer povidone (PVP-I), has been used in wound care for several decades. The microbial activity of iodine has been thought to be facilitated through several oxidative mechanisms of action and has been shown to be effective against a wide variety of pathogens. These mechanisms include inhibition of vital bacterial cellular mechanisms, denaturation of enzymes in the respiratory chain, and oxidation of key structures in cell membranes. Previously, PVP-I-containing dressings have demonstrated complete destruction of biofilm bacteria. As well, using PVP-I as a gargle has shown bactericidal activity against methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa, Enterococcus faecium, among others, more so than other antimicrobials.

Use of antibiotics immediately after surgery, saline irrigation, and debridement in the office are relatively consistent post-surgical procedures for CRS patients. However, resistance to topical antibiotics such as mupirocin, fusidic acid, and gentamicin has been demonstrated in recent years. Furthermore, out of a survey of 265 otolaryngologists, it has been found that most physicians (86.8%) prescribe antibiotics following surgery, with the majority (63.9%) only taking cultures on occasion and therefore using broad-spectrum antibiotics despite issues of overuse. In contrast, resistance to PVP-I has not been documented to date and is therefore an attractive alternative in post-surgical management of CRS patients.

There is a paucity of published data on the use of iodine after sinus surgery to treat biofilm.The purpose of this study is determining the effectiveness of PVP-I in comparison to a placebo for post-operative refractory CRS patients in a randomized controlled trial.

Primary Objective: