Reducing Perioperative S. Aureus Transmission

Not Applicable

Terminated

• Conditions: Staphylococcus Aureus; Health Care Worker Patient Transmission; Health Care Associated Infection
• Interventions: Device: Swab and decolonization using povidone-iodine cleansing

• Registration Number: NCT03638947
• Lead Sponsor: Randy Loftus

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.

Study Timeline

• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-20
• Study Start: 2018-09-20
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Results First Submitted: 2022-05-17
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-07
• Last Update Submitted: 2022-06-07
• Results First Posted: 2022-07-01
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Swab kit plus povidone-iodine soap	Swab and decolonization using povidone-iodine cleansing	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.

Primary Outcome Measures

Name	Time	Method
Quantitate the Reduction of S. Aureus Tranmission	Up to 180 days following surgery	Compare the number of S. aureus transmission events for patients who receive the standard presurgical preparation verses patients who receive decolonization interventions.

Secondary Outcome Measures

Name	Time	Method
Identify the Number of Preoperative Patients Positive for S. Aureus Using Collection Kits	Preoperative	To identify the number of patients in the preoperative setting who test positive for S. aureus.

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States