The Efficacy of Topical Povidone - Iodine Rinses in the Management of Biofilm-associated Chronic Rhinosinusitis

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.

Povidone Iodine solution 5% (0.5% available iodine) by 3MTM has been specially formulated as a nasal antiseptic. They have shown topical application to be clinically safe, tolerable and to be rapidly bacteriocidal against aerobic gram positive and gram- negative bacteria including methicillin resistant Staphylococcus aureus, methicillin resistant Staphylococcus epidermidis, vancomycin resistant Enterococcus faecium and Enterococcus faecalis (VRE) and yeast(3M study 05-011100,05-011017, 05-011322).

Iodine is the active antimicrobial component in PVP-I. It has potent bactericidal, fungicidal and viricidal properties. It is an important element in the human body and is not known to be an allergen. Therefore there are no true allergies to iodine but rare cases of intolerance. In Japan, it is commonly recommended to gargle with PVP-Ito prevent upper respiratory infections. A prospective study evaluating the effect of mouth rinsing on iodine absorption and thyroid function showed that use of the mouthwash 4 times a day for 2 weeks or once a day for 24 weeks did not affect thyroid function. An evidence based review of randomized controlled trials and comparative studies determining the efficacy and risk associated with PVP-I irrigations used in general surgery, cardiovascular surgery, urological surgery, and orthopedic surgery found no significant risk were associated with the PVP-I irrigations other than increasing serum iodine.

There is a paucity of published data on the use of iodine during or after sinus surgery to treat biofilm. This study aims to determine if topical PVP-I rinses will result in an improvement in disease severity as determined by endoscopic scores (Modified Lund-Kennedy score). Secondly, as biofilm has been recognized as a source of poor outcomes in patients with recalcitrant chronic sinusitis (CRS), the study aims to determine if there's a significant reduction in biofilm biomass (bacterial or fungal) within the sinuses of recalcitrant CRS patients. In addition, the study will evaluate if there is a significant symptomatic improvement with the use of iodine rinses post-operatively.

Primary Objective: