Reducing ESKAPE Transmission in the Operating Room

NCT ID: NCT06274918

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-12-12

Brief Summary

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This study is designed to examine the impact of a personalized, body worn alcohol dispenser on the epidemiology of ESKAPE transmission in the anesthesia work area for patients undergoing surgery requiring general anesthesia.

Detailed Description

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A solid body of published and preliminary evidence leveraging systematic phenotypic and whole cell genome analysis and innovative surveillance technology has provided great insight into the epidemiology of perioperative bacterial transmission and healthcare-associated infection (HAI) development. This work has led us to three primary assertions that serve as the foundation of our scientific premise: 1) Further progress towards HAI prevention is needed, 2) Prevention of perioperative ESKAPE transmission is an important improvement target, and 3) An evidence-based, multi-faceted program can reduce perioperative ESKAPE transmission. Further work to generate intraoperative hand hygiene improvement is indicated. We hypothesize that the proposed program will generate sustained reductions in OR ESKAPE exposure and S. aureus transmission that will lead to sustained reductions in perioperative HAIs.

Conditions

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Surgical Procedure, Unspecified

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Usual care

Patients undergoing surgery requiring general anesthesia. Usual hand hygiene devices and products will be accessible which will include but are not limited to those mounted to the wall outside of the operating room entrance and those present on the anesthesia cart.

No interventions assigned to this group

Personalized body worn alcohol dispenser

Anesthesia providers (attending anesthesiologist and their assistant (resident physician/Certified-Registered Nurse Anesthetist (CRNA), or student nurse assistant (SRNA) will receive a personalized, body worn alcohol dispenser in addition to usual hand hygiene devices/products for hand decontamination during surgery requiring general anesthesia.

Personalized Body-Worn Alcohol Dispenser

Intervention Type DEVICE

This is an alcohol dispenser that will be worn on the Anesthesia Providers scrub pants, near the hip. It will be worn by both the attending physician and the resident physician/CRNA/SRNA. The device is produced by Georgia-Pacific.

Interventions

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Personalized Body-Worn Alcohol Dispenser

This is an alcohol dispenser that will be worn on the Anesthesia Providers scrub pants, near the hip. It will be worn by both the attending physician and the resident physician/CRNA/SRNA. The device is produced by Georgia-Pacific.

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

Pediatric patient, not requiring general anesthesia and/or IV/central line placement.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RDB Bioinformatics

INDUSTRY

Sponsor Role collaborator

Georgia-Pacific

UNKNOWN

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Andrew Pugely

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Pugely, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23082877 (View on PubMed)

Awad SS. Adherence to surgical care improvement project measures and post-operative surgical site infections. Surg Infect (Larchmt). 2012 Aug;13(4):234-7. doi: 10.1089/sur.2012.131. Epub 2012 Aug 22.

Reference Type BACKGROUND
PMID: 22913334 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10580621 (View on PubMed)

Magill SS, O'Leary E, Janelle SJ, Thompson DL, Dumyati G, Nadle J, Wilson LE, Kainer MA, Lynfield R, Greissman S, Ray SM, Beldavs Z, Gross C, Bamberg W, Sievers M, Concannon C, Buhr N, Warnke L, Maloney M, Ocampo V, Brooks J, Oyewumi T, Sharmin S, Richards K, Rainbow J, Samper M, Hancock EB, Leaptrot D, Scalise E, Badrun F, Phelps R, Edwards JR; Emerging Infections Program Hospital Prevalence Survey Team. Changes in Prevalence of Health Care-Associated Infections in U.S. Hospitals. N Engl J Med. 2018 Nov 1;379(18):1732-1744. doi: 10.1056/NEJMoa1801550.

Reference Type BACKGROUND
PMID: 30380384 (View on PubMed)

World Health Organization. Antimicrobial Resistance. Global Report on Surveillance. WHO. 2014

Reference Type BACKGROUND

German RR, Lee LM, Horan JM, Milstein RL, Pertowski CA, Waller MN; Guidelines Working Group Centers for Disease Control and Prevention (CDC). Updated guidelines for evaluating public health surveillance systems: recommendations from the Guidelines Working Group. MMWR Recomm Rep. 2001 Jul 27;50(RR-13):1-35; quiz CE1-7.

Reference Type BACKGROUND
PMID: 18634202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19035777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24937345 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29907449 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29307750 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29966756 (View on PubMed)

von Eiff C, Becker K, Machka K, Stammer H, Peters G. Nasal carriage as a source of Staphylococcus aureus bacteremia. Study Group. N Engl J Med. 2001 Jan 4;344(1):11-6. doi: 10.1056/NEJM200101043440102.

Reference Type BACKGROUND
PMID: 11136954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29395508 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18719437 (View on PubMed)

Rowlands J, Yeager MP, Beach M, Patel HM, Huysman BC, Loftus RW. Video observation to map hand contact and bacterial transmission in operating rooms. Am J Infect Control. 2014 Jul;42(7):698-701. doi: 10.1016/j.ajic.2014.02.021.

Reference Type BACKGROUND
PMID: 24969122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19352154 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20686007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22467892 (View on PubMed)

Loftus RW, Patel HM, Huysman BC, Kispert DP, Koff MD, Gallagher JD, Jensen JT, Rowlands J, Reddy S, Dodds TM, Yeager MP, Ruoff KL, Surgenor SD, Brown JR. Prevention of intravenous bacterial injection from health care provider hands: the importance of catheter design and handling. Anesth Analg. 2012 Nov;115(5):1109-19. doi: 10.1213/ANE.0b013e31826a1016. Epub 2012 Oct 9.

Reference Type BACKGROUND
PMID: 23051883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23144441 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25444268 (View on PubMed)

Sundara R. Microbial Contamination of Today's Operating Room Environments. IARS Poster Session 1431. April 29th, Hyatt Regency Chicago Hotel, Chicago, Il. Accessed June 19th, 2018.

Reference Type BACKGROUND

Dancer SJ, Stewart M, Coulombe C, Gregori A, Virdi M. Surgical site infections linked to contaminated surgical instruments. J Hosp Infect. 2012 Aug;81(4):231-8. doi: 10.1016/j.jhin.2012.04.023. Epub 2012 Jun 15.

Reference Type BACKGROUND
PMID: 22704634 (View on PubMed)

Koff MD, Loftus RW, Burchman CA, Hogan DA, Beach ML. Microbial Contamination in the Anesthesia Workspace. Are We as Clean as We Think? Anesthesiology 2007; 107: A1788

Reference Type BACKGROUND

Other Identifiers

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202111418

Identifier Type: -

Identifier Source: org_study_id

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