Reducing Perioperative S. Aureus Transmission
Primary Purpose
Staphylococcus Aureus, Health Care Associated Infection, Health Care Worker Patient Transmission
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Swab and decolonization using povidone-iodine cleansing
Sponsored by
About this trial
This is an interventional health services research trial for Staphylococcus Aureus
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
Sites / Locations
- University of Iowa Hospitals and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard of Care
Swab kit plus povidone-iodine soap
Arm Description
Patient will receive by mail a kit containing swab for the nares, armpit and groin.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03638947
First Posted
August 15, 2018
Last Updated
June 7, 2022
Sponsor
Randy Loftus
Collaborators
RDB Bioinformatics, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03638947
Brief Title
Reducing Perioperative S. Aureus Transmission
Official Title
Reducing Perioperative S. Aureus Transmission Via Use of an Evidence-Based, Multimodal Program Driven by an Innovative Software Platform (OR Path Trac)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Intermediate analysis produced strong enough results that full study not needed.
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Randy Loftus
Collaborators
RDB Bioinformatics, LLC
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus, Health Care Associated Infection, Health Care Worker Patient Transmission
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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).
Allocation
Randomized
Enrollment
236 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Patient will receive by mail a kit containing swab for the nares, armpit and groin.
Arm Title
Swab kit plus povidone-iodine soap
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Swab and decolonization using povidone-iodine cleansing
Intervention Description
Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing.
Primary Outcome Measure Information:
Title
Quantitate the Reduction of S. Aureus Tranmission
Description
Compare the number of S. aureus transmission events for patients who receive the standard presurgical preparation verses patients who receive decolonization interventions.
Time Frame
Up to 180 days following surgery
Secondary Outcome Measure Information:
Title
Identify the Number of Preoperative Patients Positive for S. Aureus Using Collection Kits
Description
To identify the number of patients in the preoperative setting who test positive for S. aureus.
Time Frame
Preoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randy Loftus, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
IPD will be available for sharing immediately after publication and ending 5 years following article publication.
IPD Sharing Access Criteria
IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal
Citations:
PubMed Identifier
23082877
Citation
Vogel TR, Dombrovskiy VY, Lowry SF. Impact of infectious complications after elective surgery on hospital readmission and late deaths in the U.S. Medicare population. Surg Infect (Larchmt). 2012 Oct;13(5):307-11. doi: 10.1089/sur.2012.116. Epub 2012 Oct 19.
Results Reference
background
PubMed Identifier
27267310
Citation
Koff MD, Brown JR, Marshall EJ, O'Malley AJ, Jensen JT, Heard SO, Longtine K, O'Neill M, Longtine J, Houston D, Robison C, Moulton E, Patel HM, Loftus RW. Frequency of Hand Decontamination of Intraoperative Providers and Reduction of Postoperative Healthcare-Associated Infections: A Randomized Clinical Trial of a Novel Hand Hygiene System. Infect Control Hosp Epidemiol. 2016 Aug;37(8):888-895. doi: 10.1017/ice.2016.106. Epub 2016 Jun 7.
Results Reference
background
PubMed Identifier
10580621
Citation
Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999 Nov;20(11):725-30. doi: 10.1086/501572.
Results Reference
background
PubMed Identifier
19035777
Citation
Boucher HW, Talbot GH, Bradley JS, Edwards JE, Gilbert D, Rice LB, Scheld M, Spellberg B, Bartlett J. Bad bugs, no drugs: no ESKAPE! An update from the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jan 1;48(1):1-12. doi: 10.1086/595011.
Results Reference
background
PubMed Identifier
18719437
Citation
Loftus RW, Koff MD, Burchman CC, Schwartzman JD, Thorum V, Read ME, Wood TA, Beach ML. Transmission of pathogenic bacterial organisms in the anesthesia work area. Anesthesiology. 2008 Sep;109(3):399-407. doi: 10.1097/ALN.0b013e318182c855.
Results Reference
background
PubMed Identifier
22467892
Citation
Loftus RW, Brown JR, Koff MD, Reddy S, Heard SO, Patel HM, Fernandez PG, Beach ML, Corwin HL, Jensen JT, Kispert D, Huysman B, Dodds TM, Ruoff KL, Yeager MP. Multiple reservoirs contribute to intraoperative bacterial transmission. Anesth Analg. 2012 Jun;114(6):1236-48. doi: 10.1213/ANE.0b013e31824970a2. Epub 2012 Mar 30.
Results Reference
background
PubMed Identifier
25444268
Citation
Clark C, Taenzer A, Charette K, Whitty M. Decreasing contamination of the anesthesia environment. Am J Infect Control. 2014 Nov;42(11):1223-5. doi: 10.1016/j.ajic.2014.07.016. Epub 2014 Oct 30.
Results Reference
background
PubMed Identifier
29907449
Citation
Loftus RW, Dexter F, Robinson ADM. High-risk Staphylococcus aureus transmission in the operating room: A call for widespread improvements in perioperative hand hygiene and patient decolonization practices. Am J Infect Control. 2018 Oct;46(10):1134-1141. doi: 10.1016/j.ajic.2018.04.211. Epub 2018 Jun 12.
Results Reference
background
PubMed Identifier
29307750
Citation
Loftus RW, Dexter F, Robinson ADM. Methicillin-resistant Staphylococcus aureus has greater risk of transmission in the operating room than methicillin-sensitive S aureus. Am J Infect Control. 2018 May;46(5):520-525. doi: 10.1016/j.ajic.2017.11.002. Epub 2018 Jan 4.
Results Reference
background
PubMed Identifier
29395508
Citation
Hadder B, Patel HM, Loftus RW. Dynamics of intraoperative Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter transmission. Am J Infect Control. 2018 May;46(5):526-532. doi: 10.1016/j.ajic.2017.10.018. Epub 2018 Feb 12.
Results Reference
background
PubMed Identifier
20686007
Citation
Loftus RW, Muffly MK, Brown JR, Beach ML, Koff MD, Corwin HL, Surgenor SD, Kirkland KB, Yeager MP. Hand contamination of anesthesia providers is an important risk factor for intraoperative bacterial transmission. Anesth Analg. 2011 Jan;112(1):98-105. doi: 10.1213/ANE.0b013e3181e7ce18. Epub 2010 Aug 4.
Results Reference
background
PubMed Identifier
32219407
Citation
Loftus RW, Dexter F, Goodheart MJ, McDonald M, Keech J, Noiseux N, Pugely A, Sharp W, Sharafuddin M, Lawrence WT, Fisher M, McGonagill P, Shanklin J, Skeete D, Tracy C, Erickson B, Granchi T, Evans L, Schmidt E, Godding J, Brenneke R, Persons D, Herber A, Yeager M, Hadder B, Brown JR. The Effect of Improving Basic Preventive Measures in the Perioperative Arena on Staphylococcus aureus Transmission and Surgical Site Infections: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201934. doi: 10.1001/jamanetworkopen.2020.1934.
Results Reference
derived
Links:
URL
https://obamawhitehouse.archives.gov/the-press-office/2014/09/18/fact-sheet-obama-administration-takes-actions-combat-antibiotic-resistan
Description
Fact Sheet: Obama Administration Takes Actions to Combat Antibiotic-Resistant Bacteria
URL
https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5013a1.htm
Description
Updated Guidelines for Evaluating Public Health Surveillance Systems
Learn more about this trial
Reducing Perioperative S. Aureus Transmission
We'll reach out to this number within 24 hrs