CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,874 enrolled
Drug / intervention
mupirocin calcium ointment, 2% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01313182
NCT01313182Phase 4Completed

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

Solventum US LLC·interventional·Posted Mar 11, 2011·Updated Dec 2, 2024

In Brief

A Phase 4 clinical trial evaluating mupirocin calcium ointment, 2% and 3M Skin and Nasal Antiseptic for Surgical Site Infection. Completed, enrolled 1,874 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNew York University, 3M

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2011
Enrollment StartMar 1, 2011
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.3 years ago

Interventions

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.

3M Skin and Nasal Antisepticdrug

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.