Periprosthetic Joint InfectionNCT04274517
Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty
A study testing Sterile Water, 3.5% Betadine and 0.05% Chlorhexidine Gluconate in people with Periprosthetic Joint Infection, run by University of Southern California at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Joint Infection
- What is being tested?
- Sterile Water, 3.5% Betadine and 0.05% Chlorhexidine Gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2021to 1 Jun 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patients presenting to Keck Hospital of USC or USC Verdugo Hills Hospital for primary total knee arthroplasty or total hip arthroplasty.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Keck School of Medicine of USC
Los Angeles, California, 90033
About this study
Official title: The Effect of Dilute Chlorhexidine Versus Betadine on Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty: A Prospective Clinical Trial
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.
Read more
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.
- Conditions
- Periprosthetic Joint Infection
- Being tested
- Sterile Water, 3.5% Betadine, 0.05% Chlorhexidine Gluconate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile WaterOther
1L of sterile water used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.
3.5% BetadineOther
1L of 3.5% betadine used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.
0.05% Chlorhexidine GluconateOther
1L of clorhexidine gluconate used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.
| Study group | Role | What they receive |
|---|---|---|
| Sterile Water | Experimental | Not described Receives: Other: Sterile Water |
| 3.5% betadine | Experimental | Not described Receives: Other: 3.5% Betadine |
| 0.05% chlorhexidine gluconate | Experimental | Not described Receives: Other: 0.05% Chlorhexidine Gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial Contamination Rate of Surgical Instruments
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
Measured: 14 days
Secondary outcomes (1)
90-Day Wound Complication
Differences in 90-day wound complications and 90-day periprosthetic joint infections between the sterile water, 3.5% betadine, and 0.05% CHG surgical splash basin groups
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start16 Jan 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Why it stopped: Preliminary analysis showed lack of positive finding, indicating a substantial number of subjects required, which is not feasible based on budget and timeline.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periprosthetic Joint InfectionStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathanael Heckmann, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274517
- Sponsor's protocol ID
- HS-19-01005
- Status last verified
- Feb 2023
- First submitted
- 12 Feb 2020
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16386799Baird 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.
PubMed 6744706Frisch 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.
PubMed 29204500
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dilute Chlorhexidine Versus Betadine on Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT04274517
- Acronym / sponsor ID
- HS-19-01005
- Conditions
- Periprosthetic Joint Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary analysis showed lack of positive finding, indicating a substantial number of subjects required, which is not feasible based on budget and timeline.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 16 Jan 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 18 Feb 2020 (actual)
- 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sterile Water | Experimental | Other: Sterile Water |
| 3.5% betadine | Experimental | Other: 3.5% Betadine |
| 0.05% chlorhexidine gluconate | Experimental | Other: 0.05% Chlorhexidine Gluconate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting to Keck Hospital of USC or USC Verdugo Hills Hospital for primary total knee arthroplasty or total hip arthroplasty.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sterile Water1L of sterile water used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation. | Other | Sterile Water |
| 3.5% Betadine1L of 3.5% betadine used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation. | Other | 3.5% betadine |
| 0.05% Chlorhexidine Gluconate1L of clorhexidine gluconate used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation. | Other | 0.05% chlorhexidine gluconate |
Primary outcome
Microbial Contamination Rate of Surgical Instruments
Time frame: 14 days
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
1 secondary outcome
90-Day Wound Complication
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Preliminary analysis showed lack of positive finding, indicating a substantial number of subjects required, which is not feasible based on budget and timeline.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Background: PubMed 16386799Anto 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.
- Background: PubMed 6744706Baird 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.
- Background: PubMed 29204500Frisch 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.
- Individual participant dataSharing planned: No
Related trials for Periprosthetic Joint Infection
Recruiting
Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
Prosthetic Joint Infection of Knee
RecruitingPhase 2/3
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
Prosthetic-joint Infection
Not yet recruitingObservational study
Impact of Nutritional Status Before Joint Replacement on Infection Risk
Periprosthetic Joint Infection (PJI), Malnutitrion
RecruitingPhase 1/2
A Phase 1/2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in PJI Participants
Periprosthetic Joint Infection (PJI)
Enrolling by invitationPhase 3
Or v IV Antibiotics for Infection
Joint Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterile Water, 3.5% Betadine and 0.05% Chlorhexidine Gluconate in people with Periprosthetic Joint Infection, run by University of Southern California 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 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 9 Feb 2023. 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 was stopped early (reason given: Preliminary analysis showed lack of positive finding, indicating a substantial number of subjects required, which is not feasible based on budget and timeline.). Results are not available in the source record.
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?
Microbial Contamination Rate of Surgical Instruments (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04274517, which also lists 3 linked publications.
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 9 Feb 2023.