Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06274918
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2023-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing ESKAPE Transmission in the Operating Room
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'We will be collecting bacterial pathogens from anesthesia work area reservoirs.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'targetDuration': '90 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2023-01-31', 'studyFirstSubmitQcDate': '2024-02-15', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ESKAPE transmission events with and without the body worn device', 'timeFrame': 'Up to 96 hours from the surgial procedure', 'description': 'Reduce the number of Enterococcus, Staphylococcus aureus, Pseudomonas, and other gram-negative (i.e., Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events'}], 'secondaryOutcomes': [{'measure': 'The epidemiology of ESKAPE transmission events', 'timeFrame': 'Up to 90 days from surgery', 'description': 'To characterize the epidemiology of ESKAPE transmission with and without the device according to incidence.'}, {'measure': 'The epidemiology of ESKAPE transmission events', 'timeFrame': 'Up to 90 days from surgery', 'description': 'To characterize the epidemiology of ESKAPE transmission with and without the device according to reservoir of origin.'}, {'measure': 'The epidemiology of ESKAPE transmission events', 'timeFrame': 'Up to 90 days from surgery', 'description': 'To characterize the epidemiology of ESKAPE transmission with and without the device according to transmission location(s).'}, {'measure': 'The epidemiology of ESKAPE transmission events', 'timeFrame': 'Up to 90 days from surgery', 'description': 'To characterize the epidemiology of ESKAPE transmission with and without the device according to portal of entry (stopcock).'}, {'measure': 'The epidemiology of ESKAPE transmission events', 'timeFrame': 'Up to 90 days from surgery', 'description': 'To characterize the epidemiology of ESKAPE transmission with and without the device according to mode (within or between-case).'}, {'measure': '90-Day Healthcare-Associated Infections', 'timeFrame': '90 days following surgery', 'description': 'Number of infections occurring within 90 days of surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Procedure, Unspecified']}, 'referencesModule': {'references': [{'pmid': '23082877', 'type': 'BACKGROUND', 'citation': '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': '22913334', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10580621', 'type': 'BACKGROUND', 'citation': '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': '30380384', 'type': 'BACKGROUND', 'citation': "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."}, {'type': 'BACKGROUND', 'citation': 'World Health Organization. Antimicrobial Resistance. Global Report on Surveillance. WHO. 2014'}, {'pmid': '18634202', 'type': 'BACKGROUND', 'citation': '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': '19035777', 'type': 'BACKGROUND', '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.'}, {'pmid': '24937345', 'type': 'BACKGROUND', '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.'}, {'pmid': '29907449', 'type': 'BACKGROUND', 'citation': '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': '29307750', 'type': 'BACKGROUND', 'citation': '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': '29966756', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11136954', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29395508', 'type': 'BACKGROUND', 'citation': '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': '18719437', 'type': 'BACKGROUND', '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.'}, {'pmid': '24969122', 'type': 'BACKGROUND', 'citation': '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': '19352154', 'type': 'BACKGROUND', '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.'}, {'pmid': '20686007', 'type': 'BACKGROUND', '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.'}, {'pmid': '22467892', 'type': 'BACKGROUND', '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.'}, {'pmid': '23051883', 'type': 'BACKGROUND', '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.'}, {'pmid': '23144441', 'type': 'BACKGROUND', '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.'}, {'pmid': '25444268', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '22704634', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing surgery requiring general anesthesia and intravascular access.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Adult patients undergoing surgery requiring general anesthesia and peripheral IV and/or central line placement.\n\nExclusion Criteria:\n\nPediatric patient, not requiring general anesthesia and/or IV/central line placement.'}, 'identificationModule': {'nctId': 'NCT06274918', 'briefTitle': 'Reducing ESKAPE Transmission in the Operating Room', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Reducing Intraoperative ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter Spp.) Transmission Via Use of an Evidence-Based, Hand Hygiene Program Optimized by OR PathTrac', 'orgStudyIdInfo': {'id': '202111418'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Usual care', 'description': '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.'}, {'label': 'Personalized body worn alcohol dispenser', 'description': '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.', 'interventionNames': ['Device: Personalized Body-Worn Alcohol Dispenser']}], 'interventions': [{'name': 'Personalized Body-Worn Alcohol Dispenser', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Personalized body worn alcohol dispenser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Andrew Pugely, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '1 year from the final study completion date (earliest date) and up to an additional 24 months.', 'ipdSharing': 'YES', 'description': 'Data requests submitted to the PI will be reviewed and considered.', 'accessCriteria': 'A sumitted proposal that is reviewed and approved by the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'collaborators': [{'name': 'RDB Bioinformatics', 'class': 'INDUSTRY'}, {'name': 'Georgia-Pacific', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Andrew Pugely', 'investigatorAffiliation': 'University of Iowa'}}}}