Role of Topical Vancomycin in Reducing Infections in Hip and Knee Arthroplasty

August 1, 2023 updated by: Independent Public Healthcare Center in Rypin

Can Topical Vancomycin Prevent Periprosthetic Joint Infection in Primary Hip and Knee Arthroplasty? Multicenter Randomized Controlled Trial

The study is designed to assess the efficacy of vancomycin powder and dilute povidone-iodine lavage (VIP protocol) in reducing the PJI after primary Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA). We hypothesized that VIP protocol provides superior reduction of periprosthetic joint infection (PJI) rates after primary THA and TKA compared with diluted povidone-iodine (PI) protocol.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients who undergo primary hip or knee arthroplasty, before closure 0,35% povidone-iodine (17,5mL in 500 mL saline) solution lavage left for 3 minutes following final implantation.

Patients drawn by random numbers calculator will be administered with 1.0 g Vancomycin powder into the wound around the prosthesis and no suction will be used.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Kujawsko-pomorksie
      • Rypin, Kujawsko-pomorksie, Poland, 87-500
        • Recruiting
        • IPHC Rypin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • undergoing THA or TKA as a result of osteoarthritis or rheumatoid arthritis, can understand and comply with the study protocol, have signed the informed consent document at screening

Exclusion Criteria:

  • Patients referred to the hospital in order to undergo THA or TKA due to different reason than osteoarthritis, rheumatoid arthritis or avascular necrosis of the femoral head, such as: failed femoral neck fractures, displaced acetabular fractures or revision acetabular fractures, revision knee or hip arthroplasty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0,35% povidone-iodine solution lavage
0,35% povidone-iodine solution lavage left in wound for 3 minutes following final implantation.
Procedure: 0,35% povidone-iodine solution lavage
0,35% povidone-iodine solution lavage left for 3 minutes following final implantation
Experimental: 1.0 g Vancomycin powder into the wound
additional 1.0 g Vancomycin powder into the wound
Procedure: 1.0 g Vancomycin powder into the wound
0,35% povidone-iodine solution lavage left for 3 minutes following final implantation and additional application 1.0 g Vancomycin powder into the wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
periprosthetic joint infection
Time Frame: 90 days
infection rate in each group
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Independent Public Healthcare Center in Rypin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1234 (Department of Defense)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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