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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Drug: mupirocin calcium ointment, 2%
* Drug: 3M Skin and Nasal Antiseptic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3M Skin and Nasal Antiseptic<br>Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation | Drug: 3M Skin and Nasal Antiseptic<br>* 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.<br>* Other names: 3M Skin and Nasal Antiseptic Povidone-iodine solution;|
| Active Comparator: Bactroban Nasal<br>Mupirocin calcium ointment, 2% | Drug: mupirocin calcium ointment, 2%<br>* 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.<br>* Other names: Bactroban Nasal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 
| Re-admission Rates in the Mupirocin and Povidone-iodine Groups. | Re-admission rates in the Mupirocin and Povidone-iodine Groups. | 12 months |