Role of Topical Vancomycin in Reducing Infections in Hip and Knee Arthroplasty
Can Topical Vancomycin Prevent Periprosthetic Joint Infection in Primary Hip and Knee Arthroplasty? Multicenter Randomized Controlled Trial
1 other identifier
interventional
1,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2022
CompletedFirst Submitted
Initial submission to the registry
July 25, 2023
CompletedFirst Posted
Study publicly available on registry
August 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedAugust 2, 2023
July 1, 2023
1.9 years
July 25, 2023
August 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
periprosthetic joint infection
infection rate in each group
90 days
Study Arms (2)
0,35% povidone-iodine solution lavage
EXPERIMENTAL0,35% povidone-iodine solution lavage left in wound for 3 minutes following final implantation.
1.0 g Vancomycin powder into the wound
EXPERIMENTALadditional 1.0 g Vancomycin powder into the wound
Interventions
0,35% povidone-iodine solution lavage left for 3 minutes following final implantation and additional application 1.0 g Vancomycin powder into the wound
0,35% povidone-iodine solution lavage left for 3 minutes following final implantation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IPHC Rypin
Rypin, Kujawsko-pomorksie, 87-500, Poland
Related Publications (1)
Kulakowski M, Elster K, Szymczak M, Sleczka P, Baumgart M, Krolikowska A, Reichert P. Comparison of the effect of combined usage of povidone-iodine irrigation and topical vancomycin powder to the use of povidone-iodine irrigation alone on the periprosthetic joint infection incidence rate in patients undergoing primary total hip and knee arthroplasty: a protocol for multicenter prospective randomized clinical trial. Trials. 2024 Jul 10;25(1):468. doi: 10.1186/s13063-024-08306-3.
PMID: 38987786DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2023
First Posted
August 2, 2023
Study Start
July 1, 2022
Primary Completion
June 1, 2024
Study Completion
December 1, 2024
Last Updated
August 2, 2023
Record last verified: 2023-07