Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin

Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine

We hypothesize the application of mupirocin or povidone-iodine to the nares is equally effective in short term Staphylococcus aureus(SA)suppression. Our overall study objective is to measure the rate of deep and superficial Surgical Site Infections (SSIs) after primary hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery requiring implantation of prosthetic material, when the patient receives either nasal mupirocin or nasal povidone-iodine prior to surgery.

Secondary study objectives include:

1. Measure hospital length of stay and re-admission rates in the mupirocin and povidone-iodine groups.
2. Measure adverse events related to mupirocin and povidone-iodine.
3. Measure rate of SA resistance to mupirocin.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection
• Intervention / Treatment: Drug: 3M Skin and Nasal Antiseptic; Drug: mupirocin calcium ointment, 2%

Detailed Description

We hypothesize the application of mupirocin or povidone-iodine to the nares is equally effective in short term Staphylococcus aureus(SA)suppression. Our overall study objective is to measure the rate of deep and superficial Surgical Site Infections (SSIs) after primary hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery requiring implantation of prosthetic material, when the patient receives either nasal mupirocin or nasal povidone-iodine prior to surgery.

• Study Type: Interventional
• Enrollment (Actual): 1874
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • NYU Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primary arthroplasty or spinal fusion surgery
• Age greater than 18 years

Exclusion Criteria:

• Revision arthroplasty
• Revision spinal fusion surgery
• Primary spine surgery without implantation of prosthetic material
• Allergy to mupirocin
• Allergy to povidone-iodine
• Pregnancy
• Breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 3M Skin and Nasal Antiseptic; Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation	Drug: 3M Skin and Nasal Antiseptic; The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds.; Other Names: 3M Skin and Nasal Antiseptic Povidone-iodine solution
Active Comparator: Bactroban Nasal; Mupirocin calcium ointment, 2%	Drug: mupirocin calcium ointment, 2%; Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days. After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares.; Other Names: Bactroban Nasal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Site Infections Occurring Within 12 Months of Surgical Procedure	Measure the rate (number and percent of patients) with deep and superficial surgical site infections after primary orthopedic surgery and primary spinal fusion surgery requiring implantation of prosthetic material.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure Hospital Length of Stay in the Mupirocin and Povidone-iodine Groups.	The hospital length of stay will be measured in the Mupirocin and Povidone-iodine groups.	Post-surgery
Measure Rate of Staphylococcus Aureus Resistance to Mupirocin.	Lab cultured isolates - they will measure rate of Staphylococcus aureus resistance to mupirocin. Both arms were sampled and tested post-op.	Isolates collected and frozen immediately post-surgery.
Re-admission Rates in the Mupirocin and Povidone-iodine Groups.	Re-admission rates in the Mupirocin and Povidone-iodine Groups.	12 months

Collaborators and Investigators

• Sponsor: Solventum US LLC
• Collaborators: New York University; 3M
• Investigators: Principal Investigator: Michael Phillips, MD, NYU Langone Center

Publications and helpful links

General Publications

• Phillips M, Rosenberg A, Shopsin B, Cuff G, Skeete F, Foti A, Kraemer K, Inglima K, Press R, Bosco J. Preventing surgical site infections: a randomized, open-label trial of nasal mupirocin ointment and nasal povidone-iodine solution. Infect Control Hosp Epidemiol. 2014 Jul;35(7):826-32. doi: 10.1086/676872. Epub 2014 May 21.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: February 11, 2011
• First Submitted That Met QC Criteria: March 10, 2011
• First Posted (Estimated): March 11, 2011

Study Record Updates

• Last Update Posted (Actual): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection; Calcium-Regulating Hormones and Agents; Anti-Bacterial Agents; Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Synthesis Inhibitors; Plasma Substitutes; Blood Substitutes; Calcium; Anti-Infective Agents, Local; Povidone; Mupirocin; Povidone-Iodine
• Other Study ID Numbers: 11318