Reducing Perioperative S. Aureus Transmission

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prevent the spread of S. aureus, a dangerous bacterium, within the operating room and between patients undergoing surgery.

Detailed Description
-----------------
The purpose of this study is to prevent the spread of S. aureus, a dangerous bacterium, within the operating room and between patients undergoing surgery. The investigators will combine several approaches in a bundle of activities to achieve this goal. The bundle will include removal of bacterial pathogens from patient skin sites before surgery, from provider hands before, during, and after surgery, from environmental surfaces before and after terminal cleaning, and from the injection ports of patient intravenous catheters. The investigators will use a new surveillance system to evaluate how well the bundle, and each component of the bundle, is working. Surveillance will identify S. aureus transmission events, and movement of S. aureus between reservoirs before, during, and after surgery (perioperative). Surveillance will map transmission events to identify actionable steps to improve the bundle. An infection control perioperative team will act on the surveillance reports to proactively address the action items, and to measure the effect of their efforts for the treatment group. The investigators will compare perioperative S. aureus transmission events for patients receiving the bundle to perioperative S. aureus transmission events for patients receiving usual care.

Official Title
-----------------
Reducing Perioperative S. Aureus Transmission Via Use of an Evidence-Based, Multimodal Program Driven by an Innovative Software Platform (OR Path Trac)

Conditions
-----------------
Staphylococcus Aureus, Health Care Associated Infection, Health Care Worker Patient Transmission

Intervention / Treatment
-----------------
* Device: Swab and decolonization using povidone-iodine cleansing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Undergoing surgery (orthopedic total joint, orthopedic spine, Gynecological/Oncology, thoracic, general, hernia, colorectal, open vascular, plastic surgery and open urological) Ability to sign informed consent Require general or regional anesthesia Exclusion Criteria: Less than 18 years of age Inability to sign informed consent Procedures not included above Not requiring general or regional anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Patient will receive by mail a kit containing swab for the nares, armpit and groin. | |
| Active Comparator: Swab kit plus povidone-iodine soap<br>Patient will receive by mail a kit containing swab for the nares, armpit and groin. In addition the patient will receive decolonization treatment including povidone-iodine soap for presurgical cleansing two days prior to surgery. | Device: Swab and decolonization using povidone-iodine cleansing<br>* Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitate the Reduction of S. Aureus Tranmission | Compare the number of S. aureus transmission events for patients who receive the standard presurgical preparation verses patients who receive decolonization interventions. | Up to 180 days following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the Number of Preoperative Patients Positive for S. Aureus Using Collection Kits | To identify the number of patients in the preoperative setting who test positive for S. aureus. | Preoperative |