S. Aureus TransmissionNCT04657185
Reducing Perioperative S. Aureus Transmission Via OR PathTrac
An observational study of S. Aureus Transmission and Surgical Site Infection, run by Georgetown University at 1 site in United States.
Trial summary
Healthcare-associated infections (HAIs) occur frequently and are associated with patient harm. It is important that healthcare facilities take the necessary steps to prevent the spread of resistant bacteria. ESKAPE bacteria (Enterococcus, S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- S. Aureus Transmission, Surgical Site Infection
- What is being tested?
- OR PathTrac Feedback Optimization
- How many people
- 804 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 20 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients undergoing surgery requiring anesthesia and intravascular access.
Who may be able to join
- Adult patients requiring anesthesia and intravenous catheter placement.
Who cannot join
- Pediatric patients, without requirement of anesthesia and/or intravenous catheter placement.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University
Georgetown, District of Columbia, 20057
About this study
Official title: Reducing Perioperative S. Aureus Transmission Via Use of an Evidence-Based, Multimodal Program Driven by an Innovative Software Platform (OR PathTrac)
Healthcare-associated infections (HAIs) occur frequently and are associated with patient harm. It is important that healthcare facilities take the necessary steps to prevent the spread of resistant bacteria. ESKAPE bacteria (Enterococcus, S. aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) are particularly pathogenic. Isolation of these pathogens from intraoperative reservoirs has been associated with postoperative infection development (i.e. surgical site infections). This project involves implementation of a software platform and bacterial collection system (OR PathTrac) that leverages the epidemiology of intraoperative bacterial transmission to guide dynamic, prospective improvements in perioperative infection control measures. The investigators will assess the effectiveness of OR PathTrac feedback in optimizing an evidence-based, multifaceted, perioperative infection control program.
Read the detailed description
Our objective was to analyze the impact of surveillance feedback optimization of a multifaceted, perioperative infection control program on S. aureus transmission and SSIs. A multifaceted infection control program was implemented over 8 months (November 2018 to June 2019). A prospective cohort impact study was then conducted over 8 months (July 2019 to March 2020) to compare the incidence of within-case S. aureus transmission (primary outcome) and surgical site infection (secondary outcome) before (4.5 months) and after (3.5 months) implementation of surveillance feedback.
- Conditions
- S. Aureus Transmission, Surgical Site Infection
- Being tested
- OR PathTrac Feedback Optimization
- Keywords
- transmission, surgical site infection, s. aureus
- Medical subject headings
- Surgical Wound Infection, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OR PathTrac Feedback OptimizationOther
OR PathTrac (RDB Bioinformatics, Omaha, NE 68154) uses a systematic phenotypic approach leveraging temporal association to monitor 13 anesthesia work area reservoirs proven to be associated with high-risk intraoperative bacterial transmission events and subsequent infection development.
| Study group | Role | What they receive |
|---|---|---|
| Before OR PathTrac Feedback | Patients undergoing surgery with an evidence-based, multifaceted, perioperative infection control program in place but without OR PathTrac feedback optimization. | |
| After OR PathTrac Feedback | Patients undergoing surgery with an evidence-based, multifaceted, perioperative infection control program in place AND OR PathTrac feedback optimization. Receives: Other: OR PathTrac Feedback Optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
within-case S. aureus transmission
- aureus transmission events detected within a surgical case
Measured: From patient entry into the operating room until case end, up to 6 hours
Secondary outcomes (1)
surgical site infection
evidence of infection (office note documentation with anti-infective order and/or isolation of one or more potentially pathogenic organisms
Measured: Up to 90 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start15 Jul 2019
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for S. Aureus TransmissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 804 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- RDB Bioinformatics, University of Iowa, Trustees of Dartmouth College
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657185
- Sponsor's protocol ID
- 00000375
- Status last verified
- Sep 2025
- First submitted
- 1 Dec 2020
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Other researchers must submit a research proposal to be reviewed by Dr. Wall for determination of release.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Perioperative S. Aureus Transmission Via Use of an Evidence-Based, Multimodal Program Driven by an Innovative Software Platform (OR PathTrac)
- ClinicalTrials.gov ID
- NCT04657185
- Acronym / sponsor ID
- 00000375
- Conditions
- S. Aureus Transmission, Surgical Site Infection
- Keywords
- transmission, surgical site infection, s. aureus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 804 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- RDB Bioinformatics, University of Iowa, Trustees of Dartmouth College
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Healthcare-associated infections (HAIs) occur frequently and are associated with patient harm. It is important that healthcare facilities take the necessary steps to prevent the spread of resistant bacteria. ESKAPE bacteria (Enterococcus, S. aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) are particularly pathogenic. Isolation of these pathogens from intraoperative reservoirs has been associated with postoperative infection development (i.e. surgical site infections). This project involves implementation of a software platform and bacterial collection system (OR PathTrac) that leverages the epidemiology of intraoperative bacterial transmission to guide dynamic, prospective improvements in perioperative infection control measures. The investigators will assess the effectiveness of OR PathTrac feedback in optimizing an evidence-based, multifaceted, perioperative infection control program.
Detailed description
Our objective was to analyze the impact of surveillance feedback optimization of a multifaceted, perioperative infection control program on S. aureus transmission and SSIs. A multifaceted infection control program was implemented over 8 months (November 2018 to June 2019). A prospective cohort impact study was then conducted over 8 months (July 2019 to March 2020) to compare the incidence of within-case S. aureus transmission (primary outcome) and surgical site infection (secondary outcome) before (4.5 months) and after (3.5 months) implementation of surveillance feedback.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before OR PathTrac Feedback | – | –Patients undergoing surgery with an evidence-based, multifaceted, perioperative infection control program in place but without OR PathTrac feedback optimization. |
| After OR PathTrac Feedback | – | Other: OR PathTrac Feedback OptimizationPatients undergoing surgery with an evidence-based, multifaceted, perioperative infection control program in place AND OR PathTrac feedback optimization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing surgery requiring anesthesia and intravascular access.
Key inclusion criteria (1 listed)
- Adult patients requiring anesthesia and intravenous catheter placement.
Key exclusion criteria (1 listed)
- Pediatric patients, without requirement of anesthesia and/or intravenous catheter placement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OR PathTrac Feedback OptimizationOR PathTrac (RDB Bioinformatics, Omaha, NE 68154) uses a systematic phenotypic approach leveraging temporal association to monitor 13 anesthesia work area reservoirs proven to be associated with high-risk intraoperative bacterial transmission events and subsequent infection development. | Other | After OR PathTrac Feedback |
Primary outcome
within-case S. aureus transmission
Time frame: From patient entry into the operating room until case end, up to 6 hours
S. aureus transmission events detected within a surgical case
1 secondary outcome
surgical site infection
Time frame: Up to 90 days following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: Yes. Other researchers must submit a research proposal to be reviewed by Dr. Wall for determination of release.
Related trials for S. Aureus Transmission
Active, not recruitingPhase 4
Nasal Decolonization of Dialysis Patients Noses
Staphylococcus Aureus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of S. Aureus Transmission and Surgical Site Infection, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
within-case S. aureus transmission (time frame: From patient entry into the operating room until case end, up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.