Phase 4
N=1,697
Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin
Surgical Site Infection
Bottom Line
View on ClinicalTrials.gov: NCT01313182 ↗Enrolled (actual)
1,697
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Surgical Site Infections Occurring Within 12 Months of Surgical Procedure — 0; 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- mupirocin calcium ointment, 2% (Drug); 3M Skin and Nasal Antiseptic (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Solventum US LLC
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgical Site Infections Occurring Within 12 Months of Surgical Procedure |
0; 5 | — |
| SECONDARY Measure Hospital Length of Stay in the Mupirocin and Povidone-iodine Groups. |
— | — |
| SECONDARY Measure Rate of Staphylococcus Aureus Resistance to Mupirocin. |
21; 24 | — |
| SECONDARY Re-admission Rates in the Mupirocin and Povidone-iodine Groups. |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01313182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.