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

Primary Purpose

Osteoarthritis, Knee, Osteoarthritis, Hip, Rheumatoid Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
1.0 g Vancomycin powder into the wound
0,35% povidone-iodine solution lavage
Sponsored by
Independent Public Healthcare Center in Rypin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • IPHC RypinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

0,35% povidone-iodine solution lavage

1.0 g Vancomycin powder into the wound

Arm Description

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

additional 1.0 g Vancomycin powder into the wound

Outcomes

Primary Outcome Measures

periprosthetic joint infection
infection rate in each group

Secondary Outcome Measures

Full Information

First Posted
July 25, 2023
Last Updated
August 1, 2023
Sponsor
Independent Public Healthcare Center in Rypin
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1. Study Identification

Unique Protocol Identification Number
NCT05972603
Brief Title
Role of Topical Vancomycin in Reducing Infections in Hip and Knee Arthroplasty
Official Title
Can Topical Vancomycin Prevent Periprosthetic Joint Infection in Primary Hip and Knee Arthroplasty? Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Independent Public Healthcare Center in Rypin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Osteoarthritis, Hip, Rheumatoid Arthritis, Avascular Necrosis of Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0,35% povidone-iodine solution lavage
Arm Type
Experimental
Arm Description
0,35% povidone-iodine solution lavage left in wound for 3 minutes following final implantation.
Arm Title
1.0 g Vancomycin powder into the wound
Arm Type
Experimental
Arm Description
additional 1.0 g Vancomycin powder into the wound
Intervention Type
Procedure
Intervention Name(s)
1.0 g Vancomycin powder into the wound
Intervention Description
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
Intervention Name(s)
0,35% povidone-iodine solution lavage
Intervention Description
0,35% povidone-iodine solution lavage left for 3 minutes following final implantation
Primary Outcome Measure Information:
Title
periprosthetic joint infection
Description
infection rate in each group
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
IPHC Rypin
City
Rypin
State/Province
Kujawsko-pomorksie
ZIP/Postal Code
87-500
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Elster, Md Phd
Phone
+48662128773
Email
karol.elster@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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