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Dilute Betadine Lavage in the Prevention of Postoperative Infection

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ClinicalTrials.gov Identifier: NCT01175044
Recruitment Status : Recruiting
First Posted : August 4, 2010
Last Update Posted : June 8, 2018
Sponsor:
Collaborator:
Central DuPage Hospital
Information provided by (Responsible Party):
Rush University Medical Center

Study Description
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Brief Summary:
The purpose of this study is to examine the efficacy of a dilute betadine solution in reducing infectious complications in revision total knee arthroplasty. The investigators 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.

Condition or disease Intervention/treatment Phase
Prosthesis-Related Infections Arthroplasty Procedure: Betadine Lavage Procedure: Saline Lavage Phase 4

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 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
Study Start Date : August 2010
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Betadine Lavage
dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000ml of sterile saline irrigation
 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:
  • Betadine
  • Lavage
  • Infection
  • Revision
  • Knee
  • Arthroplasty
Placebo Comparator: Saline Lavage
2000 ml sterile saline lavage alone
 Procedure: Saline Lavage
Following revision knee surgery, 2000ml sterile saline lavage prior to closure
Other Names:
  • Saline
  • Lavage
  • Infection
  • Revision
  • Knee
  • Arthroplasty


Outcome Measures
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Primary Outcome Measures :
  1. Infection Rate [ Time Frame: 12 months ]

Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Darren R Plummer, BBA, MBA 312-432-2468 darren.plummer@rushortho.com
Contact: Craig J Della Valle, MD 312-432-2350 craigdv@yahoo.com

Locations
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Craig J Della Valle, MD         
Sub-Investigator: Darren R Plummer, BBA, MBA         
Central DuPage Hospital Recruiting
Winfield, Illinois, United States, 60190
Principal Investigator: Scott Sporer, MD         
Sponsors and Collaborators
Rush University Medical Center
Central DuPage Hospital
Investigators
Principal Investigator: Craig J Della Valle, MD Rush University Medical Center
More Information
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01175044     History of Changes
Other Study ID Numbers: 10031106
First Posted: August 4, 2010    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: October 2016

Keywords provided by Rush University Medical Center:
Revision
Knee
Arthroplasty
 Betadine
Lavage
Infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Prosthesis-Related Infections
Postoperative Complications
 Pathologic Processes
Povidone-Iodine
Anti-Infective Agents, Local
Anti-Infective Agents