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

NCT ID: NCT05972603

Last Updated: 2023-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoarthritis, Knee Osteoarthritis, Hip Rheumatoid Arthritis Avascular Necrosis of Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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0,35% povidone-iodine solution lavage

0,35% povidone-iodine solution lavage left in wound for 3 minutes following final implantation.

Group Type EXPERIMENTAL

0,35% povidone-iodine solution lavage

Intervention Type PROCEDURE

0,35% povidone-iodine solution lavage left for 3 minutes following final implantation

1.0 g Vancomycin powder into the wound

additional 1.0 g Vancomycin powder into the wound

Group Type EXPERIMENTAL

1.0 g Vancomycin powder into the wound

Intervention Type PROCEDURE

0,35% povidone-iodine solution lavage left for 3 minutes following final implantation and additional application 1.0 g Vancomycin powder into the wound

Interventions

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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

Intervention Type PROCEDURE

0,35% povidone-iodine solution lavage

0,35% povidone-iodine solution lavage left for 3 minutes following final implantation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Independent Public Healthcare Center in Rypin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IPHC Rypin

Rypin, Kujawsko-pomorksie, Poland

Site Status RECRUITING

Countries

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Poland

Facility Contacts

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Karol Elster, Md Phd

Role: primary

+48662128773

References

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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.

Reference Type DERIVED
PMID: 38987786 (View on PubMed)

Other Identifiers

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1234

Identifier Type: -

Identifier Source: org_study_id

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