Dilute Betadine Lavage in the Prevention of Postoperative Infection
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ClinicalTrials.gov Identifier: NCT01175044 |
Recruitment Status :
Completed
First Posted : August 4, 2010
Last Update Posted : August 17, 2021
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Condition or disease | Intervention/treatment | Phase |
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Prosthesis-Related Infections Arthroplasty | Procedure: Betadine Lavage Procedure: Saline Lavage | Phase 4 |
Infections in total knee arthroplasty are still a major source of morbidity and mortality in Orthopaedics. They often necessitate long term antibiotics, reoperation, and can lead to further complications such as sepsis or even death. Infection prevention remains one of the primary goals of an orthopedic surgeon. While most sources report the infection rate for primary total knee arthroplasty to be less than 1%, the reported rate for infection in revision total knee arthroplasties has been reported to be as high as 5.6%. Despite steps taken towards infection prevention such as proper administration of preoperative antibiotics, strict adherence to sterile methods, and meticulous sterile preparation of the surgical site; infection remains higher in the total knee revision arthroplasty patient population when compared to primary total knee arthroplasty. A dilute betadine lavage (0.35% to 1% povidone iodine) prior to surgical closure has been shown in general surgical procedures as well as orthopaedic spine surgeries to reduce the infection rate in their patients, but this has not been examined in total joint arthroplasty.
The study will enroll patients who are scheduled to undergo a revision total knee arthroplasty. Patients will be randomized into two groups. The treatment group will receive a dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000ml of sterile saline irrigation and the control group will receive the 2000ml sterile saline lavage alone. All other treatment will be standard of care.
Subjects will then be followed for one year post surgery for infection, as defined by Appendix 1, at intervals of 2 weeks, 6 weeks, 3 months, and one year from the date of surgery. During these visits patients will receive standard post operative care which includes infection screening. If an infection is clinically suspected with symptoms such as warmth and erythema over the joint, reduced mobility of the joint, and increasing pain at the joint, then infection data will be collected which will consist of a Erythrocyte Sedimentation Rate, C-Reactive Protein levels and a synovial fluid sample will be taken for white blood cell count and bacterial culture.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 505 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | Efficacy of a Dilute Betadine Lavage in the Prevention of Postoperative Infection in Revision Total Knee Arthroplasty |
Actual Study Start Date : | August 2010 |
Actual Primary Completion Date : | January 2019 |
Actual Study Completion Date : | July 8, 2019 |

Arm | Intervention/treatment |
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Active Comparator: Betadine Lavage
dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000ml of sterile saline irrigation
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Procedure: Betadine Lavage
Following revision knee surgery, a dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000 ml of sterile saline irrigation
Other Names:
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Placebo Comparator: Saline Lavage
2000 ml sterile saline lavage alone
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Procedure: Saline Lavage
Following revision knee surgery, 2000ml sterile saline lavage prior to closure
Other Names:
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- Infection Rate [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Scheduled to undergo revision total knee arthroplasty
Exclusion Criteria:
- Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).
- Age ≤ 17.
- Allergy to povidone iodine.
- Any condition requiring antibiotics 14 days prior to arriving for surgery.
- Patients with chronic immunosuppression (such as HIV/AIDS).
- Unable to adhere to follow up schedule and treatment.
- Patients scheduled to undergo revision total knee arthroplasty for infectious reasons.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175044
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
Central DuPage Hospital | |
Winfield, Illinois, United States, 60190 |
Principal Investigator: | Craig J Della Valle, MD | Rush University Medical Center |
Responsible Party: | Rush University Medical Center |
ClinicalTrials.gov Identifier: | NCT01175044 |
Other Study ID Numbers: |
10031106 |
First Posted: | August 4, 2010 Key Record Dates |
Last Update Posted: | August 17, 2021 |
Last Verified: | August 2021 |
Revision Knee Arthroplasty |
Betadine Lavage Infection |
Infections Communicable Diseases Prosthesis-Related Infections Disease Attributes Pathologic Processes |
Postoperative Complications Povidone-Iodine Anti-Infective Agents, Local Anti-Infective Agents |