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

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313182
• Other study ID #: 11318
• Status: Completed
• Phase: Phase 4
• Start date: March 2011
• Est. completion date: September 2012

Study information

• Verified date: January 2020
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1874
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
3M	New York University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	Re-admission Rates in the Mupirocin and Povidone-iodine Groups.	Re-admission rates in the Mupirocin and Povidone-iodine Groups.	12 months