OR PathTrac (Tracking Intra-operative Bacterial Transmission)

Bacterial Infections Clinical Trial

Official title:

An Investigation of Novel Technology to Bring Genomic Analysis to the Patient Bedside to Systematically Track and Report on ESKAPE Bacterial Transmission in Today's Operating Room Environments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03605498
• Other study ID #: 201705826
• Status: Completed
• Start date: September 5, 2017
• Est. completion date: February 12, 2018

Study information

• Verified date: February 2019
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Two patients undergoing sedation in a randomly selected operating room will be evaluated in a serial manner in order to detect transmission of pathogenic bacteria. Patient care will not change due to their participation in this study; the patients will undergo sedation and surgery according to usual practice. This study involves taking microbiology cultures from various places in the operating room before and after each procedure. Cultures will also be taken from the two patients after they are asleep and from their intravenous tubing. From both patients anesthesiologist, surgeon and their surgical team, cRNA, and nursing staff will also have cultures obtained. Each cultures will be de-identified and given a study ID number before transport to the research laboratory for microbiological assay. The patient's medical record will be reviewed for 30 days after surgery to surveil for documentation of a potential hospital acquired infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 12, 2018
• Est. primary completion date: February 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Less than 18 years of age

• Does not require peripheral intravenous and/or central venous catheter placement

• Patient refusal to participate

• Incarceration

Related Conditions & MeSH terms

• Bacterial Infections

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Sundara Reddy	B. Braun Medical Inc., RDB Bioinformatics, LLC

Country where clinical trial is conducted

United States, 

References & Publications (37)

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. — View Citation

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. — View 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. Review. — View Citation

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Cheadle WG. Risk factors for surgical site infection. Surg Infect (Larchmt). 2006;7 Suppl 1:S7-11. Review. — View Citation

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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. — View 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):888-95. doi: 10.1017/ice.2016.106. Epub 2016 Jun 7. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Aug 23. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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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. — View Citation

Perdiz LB, Yokoe DS, Furtado GH, Medeiros EA. 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):991-3. doi: 10.1017/ice.2016.86. Epub 2016 Apr 13. — View Citation

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. — View Citation

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 ß-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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Intraoperative clonal transmission of Staph aureus.	Monitor locations throughout the operating room to document clonal transmission from the area of origin.	Intraoperative period
Primary	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	Monitor for post operative healthcare associated infections.	Monitor for the presence or absence of healthcare associated infection after undergoing an operative procedure.	Up to 30 days following surgery
Secondary	Surveil for molecular links between pathogenic organisms.	Seek to identify molecular links between causative organisms of infection and bacteria found in the operating room at the time of surgery.	Up to 30 days following surgery

External Links

•   Centers for Disease Control and Prevention-Superbugs threaten hospital patients
•   Centers for Disease Control and Prevention-Winnable Battles Targets