Clinical trial NCT01313182: Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin
Official title: Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Site Infection
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: New York University
name: 3M
First posted: 2011-03-11
Enrollment: 1874
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Surgical Site Infections Occurring Within 12 Months of Surgical Procedure
timeFrame: 12 months
Secondary outcomes:
measure: Measure Hospital Length of Stay in the Mupirocin and Povidone-iodine Groups.
timeFrame: Post-surgery
measure: Measure Rate of Staphylococcus Aureus Resistance to Mupirocin.
timeFrame: Isolates collected and frozen immediately post-surgery.
measure: Re-admission Rates in the Mupirocin and Povidone-iodine Groups.
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Center
name: Michael Phillips, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phillips M, Rosenberg A, Shopsin B, Cuff G, Skeete F, Foti A, Kraemer K, Inglima K, Press R, Bosco J. Preventing surgical site infections: a randomized, open-label trial of nasal mupirocin ointment and nasal povidone-iodine solution. Infect Control Hosp Epidemiol. 2014 Jul;35(7):826-32. doi: 10.1086/676872. Epub 2014 May 21.