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

Sponsor

Independent Public Healthcare Center in Rypin (Other)

Overall Status

Recruiting

CT.gov ID

NCT05972603

Collaborator

(none)

1,000

Enrollment

Location

Arms

Anticipated Duration (Months)

34.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee Osteoarthritis, Hip Rheumatoid Arthritis Avascular Necrosis of Hip	Procedure: 1.0 g Vancomycin powder into the wound Procedure: 0,35% povidone-iodine solution lavage	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

periprosthetic joint infection [90 days]
infection rate in each group

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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