InfectionNCT02434510
Bacterial Contamination of Operative Splash Basins
An observational study of Infection, run by University of Utah at 1 site in United States.
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
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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted5 May 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Gililland, University of Utah
- Investigators
- Jeremy Gililland, M.D., Principal investigator, University of Utah
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Contamination of Operative Splash Basins: Can it be Prevented?
- ClinicalTrials.gov ID
- NCT02434510
- Acronym / sponsor ID
- 76754
- Conditions
- Infection
- Keywords
- Infection, Total Knee Arthroplasty, Total Hip Arthroplasty, Splash Basins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for primary total joint arthroplasty
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bacterial Contamination
Time frame: up to 1-3 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Gililland, M.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
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.