Povidone-Iodine for Nasal Decolonization

Surgical Wound Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05529173
• Other study ID #: Pro2021000468
• Status: Completed
• Phase: Phase 4
• Start date: September 6, 2022
• Est. completion date: November 17, 2023

Study information

• Verified date: February 2024
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: November 17, 2023
• Est. primary completion date: November 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Methicillin-Resistant Staphylococcus Aureus
• Preoperative Care
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

Drug:
• Povidone-Iodine 10%
Nasal swab stick application of Povidone-Iodine 10% prior to surgery
• 0.9% NaCl Solution
Nasal swab stick application of 0.9% NaCl Solution prior to surgery

Locations

Country	Name	City	State
United States	University Hospital	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Davis GB, Peric M, Chan LS, Wong AK, Sener SF. Identifying risk factors for surgical site infections in mastectomy patients using the National Surgical Quality Improvement Program database. Am J Surg. 2013 Feb;205(2):194-9. doi: 10.1016/j.amjsurg.2012.05.007. Epub 2012 Aug 31. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total CFU (colony forming units)	Enumeration of nasal swab samples	Perioperative Course 5 hour maximum
Secondary	Wound infection	Presence of wound infection	Up to 30 days