OR PathTrac (Tracking Intra-operative Bacterial Transmission)

NCT03605498 | Completed

• 1 other identifier: 201705826
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Healthcare-associated infections occur frequently and are associated with patient harm. These infections are becoming more difficult to treat due to antibiotic resistance. It is important that healthcare facilities take the steps necessary to prevent the spread of resistant bacteria between patients.

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (3)

• Identify transmission dynamics of pathogenic bacteria (i.e. Staph aureus).

  Focus on how Staph aureus is transmitted in the operating room by identifying key areas of origin.

  Intraoperative period

• Intraoperative clonal transmission of Staph aureus.

  Monitor locations throughout the operating room to document clonal transmission from the area of origin.

  Intraoperative period

• Identify the modes of transmission of pathogenic bacteria ((i.e. Staph aureus).

  If transmission of Staph aureus from the site of origin to another site in the operating room arena is documented, identify the modes of transmission.

  Intraoperative period

Secondary Outcomes (2)

• Monitor for post operative healthcare associated infections.

  Up to 30 days following surgery

• Surveil for molecular links between pathogenic organisms.

  Up to 30 days following surgery

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be surgical patients requiring peripheral intravenous and/or central venous catheter access and undergoing gynecology/oncology, colorectal, open vascular, total joint or cardiovascular procedures.

You may qualify if:

• At least 18 years of age
• Require peripheral intravenous and/or central venous catheter placement
• Undergoing gynecology/oncology, colorectal, open vascular, total joint or cardiovascular procedures.

You may not qualify if:

• Less than 18 years of age
• Does not require peripheral intravenous and/or central venous catheter placement
• Patient refusal to participate
• Incarceration

Sponsors & Collaborators

• Sundara Reddy: lead
• B. Braun Medical Inc.: collaborator
• RDB Bioinformatics: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (37)

• 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

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

  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.

  PMID: 18634202 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

• 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.

  PMID: 24937345 BACKGROUND

• Loftus RW, Koff MD, Brown JR, Patel HM, Jensen JT, Reddy S, Ruoff KL, Heard SO, Yeager MP, Dodds TM. The dynamics of Enterococcus transmission from bacterial reservoirs commonly encountered by anesthesia providers. Anesth Analg. 2015 Apr;120(4):827-36. doi: 10.1213/ANE.0000000000000123.

  PMID: 24937346 BACKGROUND

• Loftus RW, Brown JR, Patel HM, Koff MD, Jensen JT, Reddy S, Ruoff KL, Heard SO, Dodds TM, Beach ML, Yeager MP. Transmission dynamics of gram-negative bacterial pathogens in the anesthesia work area. Anesth Analg. 2015 Apr;120(4):819-26. doi: 10.1213/ANE.0000000000000626.

  PMID: 25790209 BACKGROUND

• Mabit C, Marcheix PS, Mounier M, Dijoux P, Pestourie N, Bonnevialle P, Bonnomet F; French Society of Orthopaedic Surgery, Traumatology (SOFCOT). Impact of a surgical site infection (SSI) surveillance program in orthopedics and traumatology. Orthop Traumatol Surg Res. 2012 Oct;98(6):690-5. doi: 10.1016/j.otsr.2012.08.001. Epub 2012 Sep 15.

  PMID: 22986014 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, 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.

  PMID: 23051883 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.

  PMID: 23144441 BACKGROUND

• 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.

  PMID: 24969122 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

• Koff MD, Corwin HL, Beach ML, Surgenor SD, Loftus RW. Reduction in ventilator associated pneumonia in a mixed intensive care unit after initiation of a novel hand hygiene program. J Crit Care. 2011 Oct;26(5):489-495. doi: 10.1016/j.jcrc.2010.12.013. Epub 2011 Mar 24.

  PMID: 21439767 BACKGROUND

• Edwards JR, Peterson KD, Mu Y, Banerjee S, Allen-Bridson K, Morrell G, Dudeck MA, Pollock DA, Horan TC. National Healthcare Safety Network (NHSN) report: data summary for 2006 through 2008, issued December 2009. Am J Infect Control. 2009 Dec;37(10):783-805. doi: 10.1016/j.ajic.2009.10.001. No abstract available.

  PMID: 20004811 BACKGROUND

• Zerbino DR, Birney E. Velvet: algorithms for de novo short read assembly using de Bruijn graphs. Genome Res. 2008 May;18(5):821-9. doi: 10.1101/gr.074492.107. Epub 2008 Mar 18.

  PMID: 18349386 BACKGROUND

• Perdiz LB, Yokoe DS, Furtado GH, Medeiros EAS. Impact of an Automated Surveillance to Detect Surgical-Site Infections in Patients Undergoing Total Hip and Knee Arthroplasty in Brazil. Infect Control Hosp Epidemiol. 2016 Aug;37(8):991-993. doi: 10.1017/ice.2016.86. Epub 2016 Apr 13.

  PMID: 27072598 BACKGROUND

• Cheadle WG. Risk factors for surgical site infection. Surg Infect (Larchmt). 2006;7 Suppl 1:S7-11. doi: 10.1089/sur.2006.7.s1-7.

  PMID: 16834549 BACKGROUND

• Owens CD, Stoessel K. Surgical site infections: epidemiology, microbiology and prevention. J Hosp Infect. 2008 Nov;70 Suppl 2:3-10. doi: 10.1016/S0195-6701(08)60017-1.

  PMID: 19022115 BACKGROUND

• Qureshi ZA, Paterson DL, Pakstis DL, Adams-Haduch JM, Sandkovsky G, Sordillo E, Polsky B, Peleg AY, Bhussar MK, Doi Y. Risk factors and outcome of extended-spectrum beta-lactamase-producing Enterobacter cloacae bloodstream infections. Int J Antimicrob Agents. 2011 Jan;37(1):26-32. doi: 10.1016/j.ijantimicag.2010.09.009. Epub 2010 Nov 13.

  PMID: 21075605 BACKGROUND

• Paryavi E, Stall A, Gupta R, Scharfstein DO, Castillo RC, Zadnik M, Hui E, O'Toole RV. Predictive model for surgical site infection risk after surgery for high-energy lower-extremity fractures: development of the risk of infection in orthopedic trauma surgery score. J Trauma Acute Care Surg. 2013 Jun;74(6):1521-7. doi: 10.1097/TA.0b013e318292158d.

  PMID: 23694882 BACKGROUND

• Arnold C. Outbreak Breakthrough: Using Whole-Genome Sequencing to Control Hospital Infection. Environ Health Perspect. 2015 Nov;123(11):A281-6. doi: 10.1289/ehp.123-A281. No abstract available.

  PMID: 26523889 BACKGROUND

• Rupp ME, Fitzgerald T, Puumala S, Anderson JR, Craig R, Iwen PC, Jourdan D, Keuchel J, Marion N, Peterson D, Sholtz L, Smith V. Prospective, controlled, cross-over trial of alcohol-based hand gel in critical care units. Infect Control Hosp Epidemiol. 2008 Jan;29(1):8-15. doi: 10.1086/524333.

  PMID: 18171181 BACKGROUND

• Moureau NL, Flynn J. Disinfection of Needleless Connector Hubs: Clinical Evidence Systematic Review. Nurs Res Pract. 2015;2015:796762. doi: 10.1155/2015/796762. Epub 2015 May 14.

  PMID: 26075093 BACKGROUND

• Schweizer ML, Chiang HY, Septimus E, Moody J, Braun B, Hafner J, Ward MA, Hickok J, Perencevich EN, Diekema DJ, Richards CL, Cavanaugh JE, Perlin JB, Herwaldt LA. Association of a bundled intervention with surgical site infections among patients undergoing cardiac, hip, or knee surgery. JAMA. 2015 Jun 2;313(21):2162-71. doi: 10.1001/jama.2015.5387.

  PMID: 26034956 BACKGROUND

• Phillips M, Rosenberg A, Shopsin B, Cuff G, Skeete F, Foti A, Kraemer K, Inglima K, Press R, Bosco J. Preventing surgical site infections: a randomized, open-label trial of nasal mupirocin ointment and nasal povidone-iodine solution. Infect Control Hosp Epidemiol. 2014 Jul;35(7):826-32. doi: 10.1086/676872. Epub 2014 May 21.

  PMID: 24915210 BACKGROUND

• Bode LG, Kluytmans JA, Wertheim HF, Bogaers D, Vandenbroucke-Grauls CM, Roosendaal R, Troelstra A, Box AT, Voss A, van der Tweel I, van Belkum A, Verbrugh HA, Vos MC. Preventing surgical-site infections in nasal carriers of Staphylococcus aureus. N Engl J Med. 2010 Jan 7;362(1):9-17. doi: 10.1056/NEJMoa0808939.

  PMID: 20054045 BACKGROUND

• Konvalinka A, Errett L, Fong IW. Impact of treating Staphylococcus aureus nasal carriers on wound infections in cardiac surgery. J Hosp Infect. 2006 Oct;64(2):162-8. doi: 10.1016/j.jhin.2006.06.010. Epub 2006 Aug 23.

  PMID: 16930768 BACKGROUND

• Chen YQ, Hu C, Wang Y. Attributable risk function in the proportional hazards model for censored time-to-event. Biostatistics. 2006 Oct;7(4):515-29. doi: 10.1093/biostatistics/kxj023. Epub 2006 Feb 14.

  PMID: 16478758 BACKGROUND

• Mehrotra DV, Li X, Liu J, Lu K. Analysis of longitudinal clinical trials with missing data using multiple imputation in conjunction with robust regression. Biometrics. 2012 Dec;68(4):1250-9. doi: 10.1111/j.1541-0420.2012.01780.x. Epub 2012 Sep 20.

  PMID: 22994905 BACKGROUND

• Carpenter J, Pocock S, Lamm CJ. Coping with missing data in clinical trials: a model-based approach applied to asthma trials. Stat Med. 2002 Apr 30;21(8):1043-66. doi: 10.1002/sim.1065.

  PMID: 11933033 BACKGROUND

• Raudenbush SW. Hierarchical Linear Models: Applications and Data Analysis Methods. Newbury Park, CA: Sage; 2002.

  BACKGROUND

• Wikler M, Cockerill F, Craig W, Dudley M, Eliopoulos G, Hecht P, Hindler J, Low D, Sheehan D, Tenover F, Turnidge J, Weinstein M, Zimmer B. Clinical and Laboratory Standards Institute: Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-9th 10th edition. 2009, Wayne, PA, Clinical and Laboratory Standards Institute, 2006, pp M2 M02-A9A10

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The bacterial cultures can be kept and analyzed at a later date to determine how they have transformed into antibiotic resistant organisms.

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Sundara Reddy, MBBS, FRCA

  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: Clinical Associate Professor

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: July 30, 2018
• Study Start: September 5, 2017
• Primary Completion: February 12, 2018
• Study Completion: February 12, 2018
• Last Updated: March 1, 2019

Record last verified: 2019-02

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)