Preventing surgical site infections: a randomized, open-label trial of nasal mupirocin ointment and nasal povidone-iodine solution

Abstract

Background: Treatment of Staphylococcus aureus colonization before surgery reduces risk of surgical site infection (SSI). The regimen of nasal mupirocin ointment and topical chlorhexidine gluconate is effective, but cost and patient compliance may be a barrier. Nasal povidone-iodine solution may provide an alternative to mupirocin.

Methods: We conducted an investigator-initiated, open-label, randomized trial comparing SSI after arthroplasty or spine fusion in patients receiving topical chlorhexidine wipes in combination with either twice daily application of nasal mupirocin ointment during the 5 days before surgery or 2 applications of povidone-iodine solution into each nostril within 2 hours of surgical incision. The primary study end point was deep SSI within the 3 months after surgery.

Results: In the modified intent-to-treat analysis, a deep SSI developed after 14 of 855 surgical procedures in the mupirocin group and 6 of 842 surgical procedures in the povidone-iodine group (P = .1); S. aureus deep SSI developed after 5 surgical procedures in the mupirocin group and 1 surgical procedure in the povidone-iodine group (P = .2). In the per protocol analysis, S. aureus deep SSI developed in 5 of 763 surgical procedures in the mupirocin group and 0 of 776 surgical procedures in the povidone-iodine group (P = .03).

Conclusions: Nasal povidone-iodine may be considered as an alternative to mupirocin in a multifaceted approach to reduce SSI.

Trial registration: ClinicalTrials.gov identifier: NCT01313182.

Conflict of interest statement

Conflict of Interest Disclosures

M. Phillips, 3M corporation (research grant which funded this study); had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

A. Rosenberg, 3M Corporation (research grant which funded this study)

B. Shopsin, 3M Corporation (research grant which funded this study) and grant funding is: R01 AI103268-01

G. Cuff, no potential conflicts of interest

F. Skeete, no potential conflicts of interest

A. Foti, no potential conflicts of interest

K. Kraemer, no potential conflicts of interest

K. Inglima, no potential conflicts of interest

B. Press, no potential conflicts of interest

J. Bosco, 3M Corporation (research grant which funded this study)

Figures

Figure 1

Flow Diagram of Study Participants

Figure 2

Mupirocin Minimum Inhibitory Concentration of Pre-operative MSSA Isolates by Study Drug, Intent to Treat Analysis

Figure 3

Mupirocin Minimum Inhibitory Concentration of Pre-operative MRSA Isolates by Study Drug, Intent to Treat Analysis