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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05972603
• Other study ID #: 1234
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Independent Public Healthcare Center in Rypin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Poland	IPHC Rypin	Rypin	Kujawsko-pomorksie

Sponsors (1)

Lead Sponsor	Collaborator
Independent Public Healthcare Center in Rypin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	periprosthetic joint infection	infection rate in each group	90 days