Bacterial Contamination of Operative Splash Basins

NCT02434510 | Completed DMC

• 1 other identifier: 76754
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the efficacy of adding 0.05% chlorhexidine gluconate to the splash basin in reducing bacterial growth from splash basins at the end of a total joint replacement procedure. Hypothesis: The 0.05% chlorhexidine gluconate solution will reduce the bacterial growth at the end of elective total joint arthroplasty cases. Null Hypothesis: There will be no difference in bacterial growth from the splash basin at the end of the case despite the addition of an antimicrobial solution.

Conditions

Infection

Keywords

Infection; Total Knee Arthroplasty; Total Hip Arthroplasty; Splash Basins

Outcome Measures

Primary Outcomes (1)

• Bacterial Contamination

  After 1-3+ days, agar plates (cultured with splash basin solution) will be pulled from incubation and examined for growth. Basins with any growth of aerobic organisms will be considered as a positive finding.

  up to 1-3 days

Study Arms (2)

Sterile Water bath

Standard of Care group using a sterile water instrument bath

CHG group

Study group using the 0.05% CHG solution in the instrument bath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for primary total joint arthroplasty

You may qualify if:

• Splash Basins will be selected from primary total joint arthroplasty cases and then randomized to a solution of either sterile water or sterile water with 0.05% CHG.
• Other than being scheduled for a primary total joint arthroplasty, the participant information will not be reviewed for selection of the splash basin, but will be collected for comparison of patient characteristics and potentially for future reference to compare infection rates in patients associated with this study.

You may not qualify if:

• Splash basin used in a revision total joint procedure
• Splash basin used in cases where the patient has a history of known periprosthetic joint infection
• Splash basin used in cases where the patient has a known allergy to chlorhexidine gluconate

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Infections

Study Officials

• Jeremy Gililland, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 5, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: February 1, 2016
• Last Updated: February 29, 2016

Record last verified: 2016-02

Locations

US (1)