Improving Case Selection for Perioperative S. Aureus Transmission Surveillance to Reduce Surgical Site Infections

NCT04299737 | Withdrawn DMC

• 1 other identifier: 201911589
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The first patient in the dyad will receive the bundle, which includes patient decolonization methods, environmental cleaning in the OR, a hand hygiene system located on the IV pole for the anesthesia provider, and intravascular catheter and syringe tip disinfection practices. The second patient in the dyad will receive usual care. Both patients will be surveyed by obtaining swab samples at the beginning and end of the surgery using the OR PathTrac kits. The OR PathTrac software (RDB Bioinformatics, Omaha, NE 68154) uses algorithms to guide analysis of the S. aureus isolates and to identify transmission events. Transmission stories are processed by the software to generate transmission maps that identify improvement successes and failures. It also identifies actionable steps to improve the bundle. The perioperative infection control team then uses this information to continually optimize the bundle, and the software to measure the effect.

Conditions

S. Aureus Transmission

Outcome Measures

Primary Outcomes (1)

• Time course in S. aureus transmission decline with the intervention.

  S. aureus transmission events by time.

  Up to 52 weeks

Secondary Outcomes (1)

• Systematic selection of sequential cases in operating rooms for surveillance to reduce sample size and increase power.

  Up to 52 weeks

Study Arms (2)

First patient in the case pair

This patient will receive the treatment bundle. S. aureus transmission surveillance will be conducted.

Other: Treatment Bundle (as defined below)

Second patient in the case pair

This patient will receive usual care. S. aureus transmission surveillance will be conducted.

Interventions

Treatment Bundle (as defined below) OTHER

Patient decolonization within one hour of incision, improved environmental cleaning (frequency and quality, including but not limited to targeted use of no touch disinfection with UV-C treatment), provider hand hygiene leveraging proximity, improved catheter disinfection, and surveillance optimization.

First patient in the case pair

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo oncologic gynecological and plastic surgery requiring general/regional anesthesia.

You may qualify if:

• Patients scheduled to undergo oncologic gynecological and plastic surgery requiring general/regional anesthesia.
• informed, written consent.

You may not qualify if:

• Patients \<18 years of age.
• Patients scheduled to undergo procedures outside of the surgical service lines listed above.
• Patients not requiring general or regional anesthesia.
• Patients who have a documented allergy or have an allergic reaction to to iodine, shellfish, or chlorhexidine.
• Patients who have not provided informed, written consent.

Sponsors & Collaborators

• Randy Loftus: lead
• RDB Bioinformatics: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (21)

• 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

• Dexter F, Ledolter J, Epstein RH, Loftus RW. Importance of operating room case scheduling on analyses of observed reductions in surgical site infections from the purchase and installation of capital equipment in operating rooms. Am J Infect Control. 2020 May;48(5):566-572. doi: 10.1016/j.ajic.2019.08.017. Epub 2019 Oct 19.

  PMID: 31640892 BACKGROUND

• Dexter F, Epstein RH, Gostine AL, Penning DH, Loftus RW. Benefit of systematic selection of pairs of cases matched by surgical specialty for surveillance of bacterial transmission in operating rooms. Am J Infect Control. 2020 Jun;48(6):682-687. doi: 10.1016/j.ajic.2019.09.025. Epub 2019 Nov 1.

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• Loftus RW, Koff MD, Brown JR, Patel HM, Jensen JT, Reddy S, Ruoff KL, Heard SO, Yeager MP, Dodds TM. The epidemiology of Staphylococcus aureus transmission in the anesthesia work area. Anesth Analg. 2015 Apr;120(4):807-18. doi: 10.1213/ANE.0b013e3182a8c16a.

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  PMID: 17129369 BACKGROUND

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  PMID: 26695819 BACKGROUND

• Koff MD, Loftus RW, Burchman CC, Schwartzman JD, Read ME, Henry ES, Beach ML. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a novel device. Anesthesiology. 2009 May;110(5):978-85. doi: 10.1097/ALN.0b013e3181a06ec3.

  PMID: 19352154 BACKGROUND

• Loftus RW, Brindeiro BS, Kispert DP, Patel HM, Koff MD, Jensen JT, Dodds TM, Yeager MP, Ruoff KL, Gallagher JD, Beach ML, Brown JR. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a passive catheter care system. Anesth Analg. 2012 Dec;115(6):1315-23. doi: 10.1213/ANE.0b013e31826d2aa4. Epub 2012 Nov 9.

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  PMID: 24915210 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

• Robinson ADM, Dexter F, Renkor V, Reddy S, Loftus RW. Operating room PathTrac analysis of current intraoperative Staphylococcus aureus transmission dynamics. Am J Infect Control. 2019 Oct;47(10):1240-1247. doi: 10.1016/j.ajic.2019.03.028. Epub 2019 Apr 27.

  PMID: 31036398 BACKGROUND

• Durkin MJ, Dicks KV, Baker AW, Lewis SS, Moehring RW, Chen LF, Sexton DJ, Anderson DJ. Seasonal Variation of Common Surgical Site Infections: Does Season Matter? Infect Control Hosp Epidemiol. 2015 Sep;36(9):1011-6. doi: 10.1017/ice.2015.121. Epub 2015 May 26.

  PMID: 26008876 BACKGROUND

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• Wilson AP, Smyth D, Moore G, Singleton J, Jackson R, Gant V, Jeanes A, Shaw S, James E, Cooper B, Kafatos G, Cookson B, Singer M, Bellingan G. The impact of enhanced cleaning within the intensive care unit on contamination of the near-patient environment with hospital pathogens: a randomized crossover study in critical care units in two hospitals. Crit Care Med. 2011 Apr;39(4):651-8. doi: 10.1097/CCM.0b013e318206bc66.

  PMID: 21242793 BACKGROUND

• Anderson DJ, Chen LF, Weber DJ, Moehring RW, Lewis SS, Triplett PF, Blocker M, Becherer P, Schwab JC, Knelson LP, Lokhnygina Y, Rutala WA, Kanamori H, Gergen MF, Sexton DJ; CDC Prevention Epicenters Program. Enhanced terminal room disinfection and acquisition and infection caused by multidrug-resistant organisms and Clostridium difficile (the Benefits of Enhanced Terminal Room Disinfection study): a cluster-randomised, multicentre, crossover study. Lancet. 2017 Feb 25;389(10071):805-814. doi: 10.1016/S0140-6736(16)31588-4. Epub 2017 Jan 17.

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• 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

• Loftus RW, Dexter F, Robinson ADM, Horswill AR. Desiccation tolerance is associated with Staphylococcus aureus hypertransmissibility, resistance and infection development in the operating room. J Hosp Infect. 2018 Nov;100(3):299-308. doi: 10.1016/j.jhin.2018.06.020. Epub 2018 Jun 30.

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Study Officials

• Randy W Loftus, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 9, 2020
• Study Start: March 9, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: July 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon request and evaluation, if approved by the PI for release, at least one year from publication date.
• Access Criteria: Submitted research protocol approved by the principal investigator, Dr. Loftus

Locations

US (1)