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InfectionNCT02434510

Bacterial Contamination of Operative Splash Basins

An observational study of Infection, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infection
How many people
111 participants
Where
1 siteUnited States
Study dates
Mar 2015to Feb 2016
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients scheduled for primary total joint arthroplasty

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Utah Orthopaedic Center

    Salt Lake City, Utah, 84108

Other trials in United States

About this study

Official title: Bacterial Contamination of Operative Splash Basins: Can it be Prevented?

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.

Read the detailed description

Total joint arthroplasty of the hip and knee is a procedure growing substantially in number in the United States. Projections approach 2 million combined total hip and total knee arthroplasty procedures by the year 2021[1, 2]. With the incidence of post-arthroplasty infection ranging from 1-2% of primaries and 3-5% of revisions, the number of cases of periprosthetic infection will be significant[1, 3-7]. The associated economic burden is projected to exceed $1.62 billion[2]. With these numbers in mind it is our responsibility in the orthopaedic community to do what we can to reduce the social and economic impact that this devastating complication creates.

While all surgical procedures carry the risk of bacterial contamination, those that implant prosthetic material are particularly high risk for future problems due to the development of biofilms and difficulty eradicating such infections. The most common time of inoculation of the implant is at the time of surgery. Whyte et al.[8] showed that the source of infection was the operating room personnel in 98% of cases while only 2% of the time it was the patient's own skin. The transfer of contaminants occurred via direct transfer through the hands or instruments 70% of the time. Knobben et al.[9] reported transfer of bacteria between biomaterial surfaces at a rate of 17%-71% demonstrating the ability of bacteria to spread to all types of materials in the operative field. The direct contact of these surfaces with the patient or prosthetic implant makes early contamination during surgery a likely cause of periprosthetic infection. Maathuis et al.[10] suggested that at least 30% of patients leave the operating suite with bacterial contamination.

The splash basin has been used for many years in the operating room as a place to wash instruments and clean them of debris for potential re-use during the surgical case. This often places multiple instruments within the bath of washings or in direct contact with previously used tools. Several studies have shown evidence of bacterial contamination of these basins[11-14]. Rates of 2.17% to 74% of contamination of the splash basin have been reported. In a study by Anto et al.[11] an average of 45.7 instruments were placed in the splash basin per case. The opportunity for bacteria to be transferred to the surgical wound upon re-use of an instrument from the basin is therefore concerning.

Given that the splash basin is a potential source of surgical wound contamination we have sought to eliminate the bacterial colonization of this source through the addition of an antimicrobial solution to the normal sterile water bath. To compare potential interventions, a prospective study comparing a 0.05% chlorhexidine gluconate (CHG) antimicrobial solution to the current standard of sterile water as a control is proposed. This concentration of CHG followed by a saline rinse has been shown to decrease the risk of infection during wound irrigation without increasing the risk of adverse effects[15, 16].

Given our expertise in the area of total joint arthroplasty and experience with treating periprosthetic infections as well as familiarity with various antimicrobial solutions we feel well qualified to perform this study. The results of this study could improve patient outcomes by potentially eliminating a source of infection in the operating room.

Conditions
Infection
Keywords
Infection, Total Knee Arthroplasty, Total Hip Arthroplasty, Splash Basins
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02434510
Study groupRoleWhat they receive
Sterile Water bathStandard of Care group using a sterile water instrument bath
CHG groupStudy group using the 0.05% CHG solution in the instrument bath

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 1-3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionOct 2015
  4. Study completionFeb 2016

Resources

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
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02434510
Sponsor's protocol ID
76754
Status last verified
Feb 2016
First submitted
30 Apr 2015
Last updated
29 Feb 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Infection, run by University of Utah 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 2 inclusion and 3 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 29 Feb 2016. 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?

Bacterial Contamination (time frame: up to 1-3 days). 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 29 Feb 2016.

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