NCT01313182

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,874 (actual)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-03-11
• Last updated: 2024-12-02
• Results posted: 2014-05-19

Locations

1 site across 1 country: United States