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NCT Number: NCT01313182

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

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.

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Medical Center

New York, 10003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mupirocin calcium ointment, 2%

Drug

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

3M Skin and Nasal Antiseptic

Drug

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

Primary outcomes

  1. Surgical Site Infections Occurring Within 12 Months of Surgical Procedure

    Time frame: 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 outcomes

  1. Measure Hospital Length of Stay in the Mupirocin and Povidone-iodine Groups.

    Time frame: Post-surgery

    The hospital length of stay will be measured in the Mupirocin and Povidone-iodine groups.

  2. Measure Rate of Staphylococcus Aureus Resistance to Mupirocin.

    Time frame: 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.

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

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M
  • New York University

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 11, 2011
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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