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

Phase 4

Completed

• Conditions: Surgical Site Infection
• Interventions: Drug: 3M Skin and Nasal Antiseptic; Drug: mupirocin calcium ointment, 2%

• Registration Number: NCT01313182
• Lead Sponsor: Solventum US LLC

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-02-11
• Study Start: 2011-03
• Study First Submitted QC: 2011-03-10
• Study First Posted: 2011-03-11
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2014-02-21
• Results First Submitted QC: 2014-04-24
• Results First Posted: 2014-05-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1874

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3M Skin and Nasal Antiseptic	3M Skin and Nasal Antiseptic	Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
Bactroban Nasal	mupirocin calcium ointment, 2%	Mupirocin calcium ointment, 2%

Primary Outcome Measures

Name	Time	Method
Surgical Site Infections Occurring Within 12 Months of Surgical Procedure	12 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States