Feasibility of Pre-operative Povidone Iodine Decolonization Among Orthopedic Trauma Surgery Patients To Reduce Staphylococcus Aureus Surgical Site Infections
Phase: PHASE4
Conditions: Surgical Site Infection
Sponsor: University of Iowa

Title: Feasibility of Pre-operative Povidone Iodine Decolonization among Orthopedic 
Trauma Surgery Patients To Reduce S. aureus SSIs  
NCT Number: NCT04146116 
July 18, 2019  

Background  
Our previous multicenter study of a bundled intervention to prevent S. aureus surgical site 
infections (SSI) resulted in a 42% decrease in complex S. aureus SSIs (rate ratio = 0.58; 95% 
CI, 0.37 to 0.92) among hip, knee and cardiac surgery patients.1 The evidence-based bundled 
intervention included screening for S. aureus nasal colonization, decolonizing carriers with 
intranasal mupirocin and chlorhexidine gluconate body wash, and prescribing optimal 
perioperative antibiotics. However, even among elective orthopedic procedures, compliance 
with this intervention was less than ideal.  
 
Decolonization interventions such as this have not been rigorously investigated in trauma 
surgery populations, because of the expeditious and non-elective nature of trauma care. Pre-
operative decolonization with mupirocin is impractical to complete in the vast majority of patients 
with orthopaedic trauma. Dr. Michael Willey, an orthopaedic trauma surgeon, went to great 
lengths to implement S. aureus screening and mupirocin decolonization of carriers among his 
patient population at University of Iowa Hospitals and Clinics (UIHC). Yet, even with full surgeon 
support, compliance with S. aureus nasal screening was 80% and compliance with mupirocin 
was only 41%. Thus, there is great interest in determining whether a simpler intervention using 
povidone-iodine (PROFEND®) nasal decolonization could be implemented into the clinical 
process of care and reduce rates of surgical site infections (SSI) in this very high-risk 
population.  
 
PROFEND® nasal decolonization has the potential to be an efficient and low-cost intervention 
to reduce rates of SSI.2,3 Although orthopaedic trauma patients are at high risk of SSI, our 
sample size and power calculations found that a study evaluating the effectiveness of nasal 
PROFEND® for reducing deep SSI in this population would need ~1,000 patients, and thus 
would require participation by multiple hospitals. A pilot study evaluating the feasibility of 
administering PROFEND® among patients undergoing orthopaedic trauma procedures could 
inform the development and implementation of a large, multicenter study.  
 
This proposal describes a small, phase IV post-marketing study to assess the best way to 
implement this FDA approved product among surgical patients.  
 
Study design  
Implement PROFEND® pre-operative decolonization for individuals undergoing operative 
fixation of lower extremity fractures and evaluate the feasibility of this intervention.  
Aim 1. Evaluate patients 24 hours after surgery to determine S. aureus colonization and 
to survey patients on tolerability of PROFEND® decolonization.  
 
Patients will be tested for S. aureus nasal colonization prior to surgery, the evening after surgery 
and on the day after surgery. At each time point, a dry, sterile, rayon swab will be used to 
sample the anterior apex portion of the right and left nostril. The swab will be immersed in a 
tube of 1 mL neutralizing solution (75 mM phosphate buffer containing 1.0% lecithin, 0.1% 
Triton™ X-100, 5.0% polyoxyethylene sorbitan monooleate, and 0.5% sodium thiosulfate, pH 
7.9 + 0.1) and capped tightly. The swabs will be inoculated into 1mL broth and vortexed for 15 
seconds. Serial dilutions will be performed and plated on media. The cultures will be 
quantitatively assessed to determine the log10 reduction in S. aureus after use of PROFEND®. 
For semi-quantitative cultures the swabs will be inoculated into 5mL broth, incubated with 
agitation overnight for a broth enrichment step. After 24 hours, 10uL will be plated onto the first 
quadrant of the media and each successive quadrant will be streaked using a new bacteriologic 
loop in order to dilute the number of bacteria in each quadrant. The culture results will provide 
information we will need when designing a large multicenter study of PROFEND®. The 

PROFEND® swab will be administered to the patient’s nares following this initial sample around 
one hour prior to the first surgical incision. It will then be re-applied around 12 hours later, for a 
total of two applications within a 24 hour period.  
 
During the same visit at 24 hours after surgery, patients will also be administered a 
questionnaire to determine the tolerability of PROFEND® decolonization. Questions will be 
asked about adverse events (e.g., itching, irritation) and how PROFEND® felt (very pleasant, 
pleasant, neutral, unpleasant, very unpleasant). The adverse event question will be the same as 
a question that we have already asked 183 patients who received mupirocin. Thus, we will be 
able to compare these results with one another.  
 
Based on the data obtained from this aim, we will summarize the patient acceptance of 
PROFEND®.  
 
 
References  
1. Schweizer ML, Chiang HY, Septimus E, et al. Association of a bundled intervention with surgical site 
infections among patients undergoing cardiac, hip, or knee surgery. JAMA : the journal of the American 
Medical Association. 2015;313(21):2162-2171.  
2. Bebko SP, Green DM, Awad SS. Effect of a Preoperative Decontamination Protocol on Surgical Site 
Infections in Patients Undergoing Elective Orthopedic Surgery With Hardware Implantation. JAMA 
surgery. 2015.  
3. Phillips M, Rosenberg A, Shopsin B, et al. Preventing surgical site infections: a randomized, open-label 
trial of nasal mupirocin ointment and nasal povidone-iodine solution. Infection control and hospital 
epidemiology : the official journal of the Society of Hospital Epidemiologists of America. 2014;35(7):826-
832.