Clinical trial NCT04274517: Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty
Official title: The Effect of Dilute Chlorhexidine Versus Betadine on Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty: A Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Periprosthetic Joint Infection
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The usage of splash basins in the setting of total knee arthroplasty and total hip arthroplasty presents a risk of contamination and subsequent periprosthetic joint infection. Previous studies have investigated the efficacy of multiple antimicrobial irrigants for preventing periprosthetic joint infection, but the results are varied.

Despite several noteworthy studies on the appropriate usage of different antiseptic solutions in surgical splash basins, the current literature has several limitations. First, there are no head-to-head clinical trials comparing betadine and chlorhexidine gluconate (CHG) usage with relation to periprosthetic joint infection and splash basin contamination rates. Second, the in vitro studies directly cultured splash basin antiseptic solutions rather than culturing surgical instruments.

The objective of this study is to compare the microbial contamination rate of total joint arthroplasty instruments that have been placed in surgical splash basins filled with either sterile water, 3.5% betadine, or 0.05% CHG. The overall purpose of the study is to investigate the efficacy of 0.05% CHG and determine if it is an appropriate solution to use in surgical splash basins for joint replacement surgeries.

A prospective clinical trial will be conducted. Patients treated at the Keck Hospital of USC or USC Verdugo Hills Hospital for primary total hip or total knee arthroplasty will be screened for inclusion in our study. All primary surgeries will be performed according to the preferences of the operating surgeon. No deviations from standard surgical care will be made based on inclusion in this study. However, prior to surgery, patients who elect to participate will be randomized to one of three groups: (1) sterile water, (2) 3.5% betadine, or (3) 0.05% CHG.


Eligibility criteria: Inclusion Criteria:

* Patients presenting to Keck Hospital of USC or USC Verdugo Hills Hospital for primary total knee arthroplasty or total hip arthroplasty.

Exclusion Criteria:

* Age \< 18 years.
* History of previous total hip arthroplasty or total knee arthroplasty.
* History of previous knee or hip joint infection.
* History of previous allergic reaction to chlorhexidine.
* Known allergy to iodine or shellfish.

Primary outcomes:
measure: Microbial Contamination Rate of Surgical Instruments
timeFrame: 14 days
Secondary outcomes:
measure: 90-Day Wound Complication
timeFrame: 90 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC
state: California
Study officials:
References:
citation: Anto B, McCabe J, Kelly S, Morris S, Rynn L, Corbett-Feeney G. Splash basin bacterial contamination during elective arthroplasty. J Infect. 2006 Mar;52(3):231-2. doi: 10.1016/j.jinf.2005.06.013. Epub 2005 Dec 28. No abstract available.
citation: Baird RA, Nickel FR, Thrupp LD, Rucker S, Hawkins B. Splash basin contamination in orthopaedic surgery. Clin Orthop Relat Res. 1984 Jul-Aug;(187):129-33.
citation: Frisch NB, Kadri OM, Tenbrunsel T, Abdul-Hak A, Qatu M, Davis JJ. Intraoperative chlorhexidine irrigation to prevent infection in total hip and knee arthroplasty. Arthroplast Today. 2017 May 12;3(4):294-297. doi: 10.1016/j.artd.2017.03.005. eCollection 2017 Dec.