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Improving Case Selection for Perioperative S. Aureus Transmission Surveillance to Reduce Surgical Site Infections

Improving Case Selection for Perioperative S. Aureus Transmission Surveillance to Reduce Surgical Site Infections

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04299737
Enrollment
0
Registered
2020-03-09
Start date
2020-03-09
Completion date
2021-08-01
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S. Aureus Transmission

Brief summary

The first patient in the dyad will receive the bundle, which includes patient decolonization methods, environmental cleaning in the OR, a hand hygiene system located on the IV pole for the anesthesia provider, and intravascular catheter and syringe tip disinfection practices. The second patient in the dyad will receive usual care. Both patients will be surveyed by obtaining swab samples at the beginning and end of the surgery using the OR PathTrac kits. The OR PathTrac software (RDB Bioinformatics, Omaha, NE 68154) uses algorithms to guide analysis of the S. aureus isolates and to identify transmission events. Transmission stories are processed by the software to generate transmission maps that identify improvement successes and failures. It also identifies actionable steps to improve the bundle. The perioperative infection control team then uses this information to continually optimize the bundle, and the software to measure the effect.

Detailed description

Surgical site infections increase patient morbidity and healthcare costs. The Centers for Disease Control and Prevention emphasizes improved basic preventive measures to reduce bacterial transmission and infections for patients undergoing surgery. Patients undergoing planned oncologic gynecological and plastic surgery will be entered as dyads into a worksheet each day that will rank and select the optimal cases. The research assistants consent both patients in the dyad to the study while they are in the Day of Surgery Admissions area. The first patient in the dyad will receive the bundle, which includes patient decolonization methods, environmental cleaning in the OR, a hand hygiene system located on the IV pole for the anesthesia provider, and intravascular catheter and syringe tip disinfection practices. The second patient in the dyad will receive usual care. Both patients will be surveyed by obtaining swab samples at the beginning and end of the surgery using the OR PathTrac kits. The OR PathTrac kits are obtained from and analyzed for S. aureus isolates by RDB Bioinformatics. The OR PathTrac software (RDB Bioinformatics, Omaha, NE 68154) uses algorithms to guide analysis of the S. aureus isolates and to identify transmission events. Transmission stories are processed by the software to generate transmission maps that identify improvement successes and failures. It also identifies actionable steps to improve the bundle. The perioperative infection control team then uses this information to continually optimize the bundle, and the software to measure the effect.

Interventions

OTHERTreatment Bundle (as defined below)

Patient decolonization within one hour of incision, improved environmental cleaning (frequency and quality, including but not limited to targeted use of no touch disinfection with UV-C treatment), provider hand hygiene leveraging proximity, improved catheter disinfection, and surveillance optimization.

Sponsors

RDB Bioinformatics
CollaboratorINDUSTRY
Randy Loftus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients scheduled to undergo oncologic gynecological and plastic surgery requiring general/regional anesthesia. * informed, written consent.

Exclusion criteria

* Patients \<18 years of age. * Patients scheduled to undergo procedures outside of the surgical service lines listed above. * Patients not requiring general or regional anesthesia. * Patients who have a documented allergy or have an allergic reaction to to iodine, shellfish, or chlorhexidine. * Patients who have not provided informed, written consent.

Design outcomes

Primary

MeasureTime frameDescription
Time course in S. aureus transmission decline with the intervention.Up to 52 weeksS. aureus transmission events by time.

Secondary

MeasureTime frameDescription
Systematic selection of sequential cases in operating rooms for surveillance to reduce sample size and increase power.Up to 52 weeksThe outcome is the proportional reduction in the necessary sample size of pairs of cases achieved by systematic selection of sample cases as compared with random selection.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026