Dilute Betadine Lavage in the Prevention of Postoperative Infection
Condition: Prosthesis-Related Infections; Arthroplasty
MeSH terms: Infections; Communicable Diseases; Prosthesis-Related Infections
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Betadine Lavage; Saline Lavage
Intervention type(s): Procedure; Procedure
Intervention description(s): Following revision knee surgery, a dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000 ml of sterile saline irrigation; Following revision knee surgery, 2000ml sterile saline lavage prior to closure
Other intervention name(s): Betadine; Lavage; Infection; Revision; Knee; Arthroplasty; Saline; Lavage; Infection; Revision; Knee; Arthroplasty
Intervention MeSH terms: Povidone-Iodine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Revision; Knee; Arthroplasty; Betadine; Lavage; Infection