Dilute Betadine Lavage in the Prevention of Postoperative Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Rush University Medical Center
Sponsor:
Collaborator:
Central DuPage Hospital
Information provided by (Responsible Party):
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01175044
First received: August 2, 2010
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Prosthesis-Related Infections
Arthroplasty
Procedure: Betadine Lavage
Procedure: Saline Lavage
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Efficacy of a Dilute Betadine Lavage in the Prevention of Postoperative Infection in Revision Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Infection Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: August 2010
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01175044     History of Changes
Other Study ID Numbers: 10031106
Study First Received: August 2, 2010
Last Updated: August 29, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 20, 2014