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Reducing Perioperative S. Aureus Transmission

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ClinicalTrials.gov Identifier: NCT03638947
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
RDB Bioinformatics, LLC
Information provided by (Responsible Party):
Randy Loftus, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Health Care Associated Infection Health Care Worker Patient Transmission Device: Swab and decolonization using povidone-iodine cleansing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: After the patient has signed consent, they will receive a pre-surgical kit that will include swabs to be used in the nares, arm pit and groin area (standard of care). In a 1:1 randomization scheme, one half of the patients will receive povidone-iodine swab in addition to the kit (treatment).
Primary Purpose: Health Services Research
Official Title: Reducing Perioperative S. Aureus Transmission Via Use of an Evidence-Based, Multimodal Program Driven by an Innovative Software Platform (OR Path Trac)
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard of Care
Patient will receive by mail a kit containing swab for the nares, armpit and groin.
Active Comparator: Swab kit plus povidone-iodine soap
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
Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing.




Primary Outcome Measures :
  1. Identify the number of perioperative S. aureus reservoirs using collection kits [ Time Frame: Perioperative time. ]
    To identify locations that harbor S. aureus reservoirs immediately prior to surgery and during the operative procedure, the investigators will surveil the patient's skin, surgical team's hands, injection ports of the patient's catheters and environmental sites within the operating room suite using sterile collection kits.


Secondary Outcome Measures :
  1. Map the number of S. aureus transmission events using OR Path Trac software [ Time Frame: Up to 180 days following surgery ]
    OR Path Trac software algorithms will map how S. aureus is transmitted from an initially identified reservoir to another location within the perioperative arena.

  2. Quantitate the reduction of S. aureus tranmission [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638947


Contacts
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Contact: Randy Loftus, MD 319-467-6795 randy-loftus@uiowa.edu
Contact: Zita A Sibenaller, PhD 319-356-8878 zita-sibenaller@uiowa.edu

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Randy Loftus, MD         
Sponsors and Collaborators
Randy Loftus
RDB Bioinformatics, LLC
Investigators
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Principal Investigator: Randy Loftus, MD University of Iowa

Additional Information:
Publications:

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Responsible Party: Randy Loftus, Clinical Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03638947     History of Changes
Other Study ID Numbers: 201802843
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.
Supporting Materials: Study Protocol
Time Frame: IPD will be available for sharing immediately after publication and ending 5 years following article publication.
Access Criteria: IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cross Infection
Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes