Reducing Perioperative S. Aureus Transmission

NCT03638947 | Terminated Results FDA Device

• 1 other identifier: 201802843
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcus Aureus; Health Care Associated Infection; Health Care Worker Patient Transmission

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Identify the Number of Preoperative Patients Positive for S. Aureus Using Collection Kits

  Preoperative

Study Arms (2)

Standard of Care

NO INTERVENTION

Patient will receive by mail a kit containing swab for the nares, armpit and groin.

Swab kit plus povidone-iodine soap

ACTIVE COMPARATOR

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

Interventions

Swab and decolonization using povidone-iodine cleansing DEVICE

Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing.

Swab kit plus povidone-iodine soap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Less than 18 years of age
• Inability to sign informed consent
• Procedures not included above
• Not requiring general or regional anesthesia

Sponsors & Collaborators

• Randy Loftus: lead
• RDB Bioinformatics: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (12)

• 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.

  PMID: 23082877 BACKGROUND

• 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.

  PMID: 27267310 BACKGROUND

• 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.

  PMID: 10580621 BACKGROUND

• 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.

  PMID: 19035777 BACKGROUND

• 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.

  PMID: 18719437 BACKGROUND

• 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.

  PMID: 22467892 BACKGROUND

• 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.

  PMID: 25444268 BACKGROUND

• 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.

  PMID: 29907449 BACKGROUND

• 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.

  PMID: 29307750 BACKGROUND

• 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.

  PMID: 29395508 BACKGROUND

• 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.

  PMID: 20686007 BACKGROUND

• 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.

  PMID: 32219407 DERIVED

Related Links

• Fact Sheet: Obama Administration Takes Actions to Combat Antibiotic-Resistant Bacteria
• Updated Guidelines for Evaluating Public Health Surveillance Systems

MeSH Terms

Conditions

Staphylococcal Infections; Cross Infection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Randy W. Loftus
• Organization: UIOWA

randy-loftus@uiowa.edu

6033066475

Study Officials

• Randy Loftus, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 20, 2018
• Study Start: September 20, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: July 1, 2022
• Results First Posted: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

US (1)