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

Not Applicable

Recruiting

• Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip; Avascular Necrosis of Hip; Rheumatoid Arthritis
• Interventions: Procedure: 0,35% povidone-iodine solution lavage; Procedure: 1.0 g Vancomycin powder into the wound

• Registration Number: NCT05972603
• Lead Sponsor: Independent Public Healthcare Center in Rypin

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.

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 Timeline

• Study Start: 2022-07-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-08-01
• Last Update Submitted: 2023-08-01
• Study First Posted: 2023-08-02
• Last Update Posted: 2023-08-02
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0,35% povidone-iodine solution lavage	0,35% povidone-iodine solution lavage	0,35% povidone-iodine solution lavage left in wound for 3 minutes following final implantation.
1.0 g Vancomycin powder into the wound	1.0 g Vancomycin powder into the wound	additional 1.0 g Vancomycin powder into the wound

Primary Outcome Measures

Name	Time	Method
periprosthetic joint infection	90 days	infection rate in each group

Trial Locations

Locations (1)

IPHC Rypin; 🇵🇱 Rypin, Kujawsko-pomorksie, Poland