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

I

Independent Public Healthcare Center in Rypin

Status

Enrolling

Conditions

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

Treatments

Procedure: 1.0 g Vancomycin powder into the wound
Procedure: 0,35% povidone-iodine solution lavage

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,000 participants in 2 patient groups

0,35% povidone-iodine solution lavage
Experimental group
Description:
0,35% povidone-iodine solution lavage left in wound for 3 minutes following final implantation.
Treatment:
Procedure: 0,35% povidone-iodine solution lavage
1.0 g Vancomycin powder into the wound
Experimental group
Description:
additional 1.0 g Vancomycin powder into the wound
Treatment:
Procedure: 1.0 g Vancomycin powder into the wound

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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