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

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
mupirocin calcium ointment, 2%
3M Skin and Nasal Antiseptic
Sponsored by
3M
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

3M Skin and Nasal Antiseptic

Bactroban Nasal

Arm Description

Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation

Mupirocin calcium ointment, 2%

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Re-admission Rates in the Mupirocin and Povidone-iodine Groups.
Re-admission rates in the Mupirocin and Povidone-iodine Groups.

Full Information

First Posted
February 11, 2011
Last Updated
January 3, 2020
Sponsor
3M
Collaborators
New York University
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1. Study Identification

Unique Protocol Identification Number
NCT01313182
Brief Title
Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin
Official Title
Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
Collaborators
New York University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Measure hospital length of stay and re-admission rates in the mupirocin and povidone-iodine groups. Measure adverse events related to mupirocin and povidone-iodine. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1874 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3M Skin and Nasal Antiseptic
Arm Type
Active Comparator
Arm Description
Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
Arm Title
Bactroban Nasal
Arm Type
Active Comparator
Arm Description
Mupirocin calcium ointment, 2%
Intervention Type
Drug
Intervention Name(s)
mupirocin calcium ointment, 2%
Other Intervention Name(s)
Bactroban Nasal
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
3M Skin and Nasal Antiseptic
Other Intervention Name(s)
3M Skin and Nasal Antiseptic Povidone-iodine solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Surgical Site Infections Occurring Within 12 Months of Surgical Procedure
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Measure Hospital Length of Stay in the Mupirocin and Povidone-iodine Groups.
Description
The hospital length of stay will be measured in the Mupirocin and Povidone-iodine groups.
Time Frame
Post-surgery
Title
Measure Rate of Staphylococcus Aureus Resistance to Mupirocin.
Description
Lab cultured isolates - they will measure rate of Staphylococcus aureus resistance to mupirocin. Both arms were sampled and tested post-op.
Time Frame
Isolates collected and frozen immediately post-surgery.
Title
Re-admission Rates in the Mupirocin and Povidone-iodine Groups.
Description
Re-admission rates in the Mupirocin and Povidone-iodine Groups.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Phillips, MD
Organizational Affiliation
NYU Langone Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24915210
Citation
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.
Results Reference
result

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

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