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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04299737
Other study ID # 201911589
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date March 9, 2020
Est. completion date August 1, 2021

Study information

Verified date July 2021
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Treatment 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.

Locations

Country Name City State
United States University of Iowa Iowa City Iowa

Sponsors (2)

Lead Sponsor Collaborator
Randy Loftus RDB Bioinformatics

Country where clinical trial is conducted

United States, 

References & Publications (21)

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Outcome

Type Measure Description Time frame Safety issue
Primary Time course in S. aureus transmission decline with the intervention. S. aureus transmission events by time. Up to 52 weeks
Secondary Systematic selection of sequential cases in operating rooms for surveillance to reduce sample size and increase power. The 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. Up to 52 weeks
See also
  Status Clinical Trial Phase
Completed NCT04657185 - Reducing Perioperative S. Aureus Transmission Via OR PathTrac