Clinical trial NCT05529173: Povidone-Iodine for Nasal Decolonization
Official title: A Prospective Single-blind Placebo-controlled Trial to Establish the Efficacy and Tolerability of 10% Povidone-Iodine for Nasal S. Aureus and Methicillin Resistant S. Aureus (MRSA) Decolonization Among Patients Undergoing Same-day Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Wound Infection
Preoperative Care
Methicillin-Resistant Staphylococcus Aureus
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are assigned to treatment group or placebo
Primary purpose: PREVENTION

Brief summary: To evaluate the efficacy and tolerability of 10% povidone-iodine in eliminating nasal carriage of Staphylococcus aureus and MRSA. To determine whether a more convenient, single-dose, pre-operative 10% povidone-iodine (PI) application is effective in reducing nasal carriage of S. aureus and MRSA. We expect a statistically significant decrease in S. aureus/MRSA colonization in nasal cultures taken perioperatively after intervention in patients who received pretreatment with PI as compared to patients who received normal saline (NS).

Detailed description: This will be a prospective single-blinded randomized placebo-controlled trial of two applications of a nasal 10% Povidone Iodine (PI) solution used on the intranasal mucosal surfaces of each nostril in the preoperative holding area within 2 h prior to surgical incision compared with NS using the same technique. Both the PI and NS will be applied by rotating the swab over the intranasal mucosal surface for 15 seconds; this process will be performed twice for both nostrils, using a new swab for each application. Nasal cultures will be obtained prior to PI or NS application as well as intraoperatively 1 hour and 2 hours after first surgical incision. The primary study end point is the decrease in S. aureus/MRSA colony forming units (CFU) in nasal cultures taken within 2 hours after intervention in patients who presented with a positive preintervention nasal culture. A secondary endpoint is the presence or absence of surgical site infections within 30 days postoperatively

Eligibility criteria: Inclusion Criteria:

* community-based patients ages 18-80
* American Society of Anesthesiology (ASA) 1-3
* undergoing an outpatient surgery for at least 1 hour and up to 6 hours duration

Exclusion Criteria:

* pregnancy
* allergy to povidone-iodine
* infectious indication for surgery or preexisting known infection/wound
* immunocompromised state
* use of chemotherapy or steroids within 30 days prior to surgery
* use of antimicrobial therapy within 30 days prior to surgery
* surgeries where field avoidance prevents intraoperative access to the nares

Primary outcomes:
measure: Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen.
timeFrame: 1, 2, and 3 hours after application of Povidone-Iodine or saline solution
Secondary outcomes:
measure: Surgical Site Infections
timeFrame: at 7 and 30-day postoperative intervals
Other outcomes:
Locations:
city: Newark
country: United States
facility: University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Alex Bekker, MD/PhD
role: STUDY_CHAIR
References:
citation: Kirby JP, Mazuski JE. Prevention of surgical site infection. Surg Clin North Am. 2009 Apr;89(2):365-89, viii. doi: 10.1016/j.suc.2009.01.001.
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citation: Craft RO, Damjanovic B, Colwell AS. Evidence-based protocol for infection control in immediate implant-based breast reconstruction. Ann Plast Surg. 2012 Oct;69(4):446-50. doi: 10.1097/SAP.0b013e31824a215a.
citation: Kalra L, Camacho F, Whitener CJ, Du P, Miller M, Zalonis C, Julian KG. Risk of methicillin-resistant Staphylococcus aureus surgical site infection in patients with nasal MRSA colonization. Am J Infect Control. 2013 Dec;41(12):1253-7. doi: 10.1016/j.ajic.2013.05.021. Epub 2013 Aug 21.
citation: Salih L, Tevell S, Mansson E, Nilsdotter-Augustinsson A, Hellmark B, Soderquist B. Staphylococcus epidermidis isolates from nares and prosthetic joint infections are mupirocin susceptible. J Bone Jt Infect. 2018 Jan 1;3(1):1-4. doi: 10.7150/jbji.22459. eCollection 2018.