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| Name | Class |
|---|---|
| B. Braun Medical Inc. | INDUSTRY |
| RDB Bioinformatics | INDUSTRY |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Surveil for molecular links between pathogenic organisms. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Sundara Reddy, MBBS, FRCA | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23082877 | Background | 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. | |
| 27267310 | 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. |
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All of the individual participant data collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.
IPD will be available for sharing immediately after publication and ending 5 years following article publication.
IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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The bacterial cultures can be kept and analyzed at a later date to determine how they have transformed into antibiotic resistant 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 |
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| Background | World Health Organization. Antimicrobial Resistance. Global Report on Surveillance, WHO. 2014 |
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