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Prosthesis-Related InfectionsPhase 4NCT01175044

Dilute Betadine Lavage in the Prevention of Postoperative Infection

A Phase 4 study testing Betadine Lavage and Saline Lavage in people with Prosthesis-Related Infections and Arthroplasty, run by Rush University Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Prosthesis-Related Infections, Arthroplasty
What is being tested?
Betadine Lavage and Saline Lavage
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
505 participants
Where
2 sitesUnited States
Study dates
Aug 2010to 8 Jul 2019
Phase
Phase 4
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Scheduled to undergo revision total knee arthroplasty

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Central DuPage Hospital

    Winfield, Illinois, 60190

Other trials in United States

About this study

Official title: Efficacy of a Dilute Betadine Lavage in the Prevention of Postoperative Infection in Revision Total Knee Arthroplasty

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.

Read the 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.

Being tested
Betadine Lavage, Saline Lavage
Keywords
Revision, Knee, Arthroplasty, Betadine, Lavage, Infection
Medical subject headings
Prosthesis-Related Infections, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Betadine LavageProcedure or surgery

    Also called Betadine, Lavage, Infection, Revision

    Following revision knee surgery, a dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000 ml of sterile saline irrigation

  • Saline LavageProcedure or surgery

    Also called Saline, Lavage, Infection, Revision

    Following revision knee surgery, 2000ml sterile saline lavage prior to closure

Study groups in NCT01175044
Study groupRoleWhat they receive
Betadine LavageActive comparatordilute betadine lavage prior to surgical closure for 3 minutes followed by 2000ml of sterile saline irrigation
Receives: Procedure: Betadine Lavage
Saline LavagePlacebo comparator2000 ml sterile saline lavage alone
Receives: Procedure: Saline Lavage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infection Rate

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionJan 2019
  4. Study completion8 Jul 2019

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
505 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01175044
Sponsor's protocol ID
10031106
Status last verified
Aug 2021
First submitted
2 Aug 2010
Last updated
17 Aug 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Betadine Lavage and Saline Lavage in people with Prosthesis-Related Infections and Arthroplasty, run by Rush University Medical Center at 2 sites 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 7 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: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Infection Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 Aug 2021.

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