Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05972603
Status:
RECRUITING
Last Update Posted:
2023-08-02
First Post:
2023-07-25
Brief Title:
Role of Topical Vancomycin in Reducing Infections in Hip and Knee Arthroplasty
Sponsor:
Independent Public Healthcare Center in Rypin
Organization:
Independent Public Healthcare Center in Rypin
Study Overview
Official Title:
Can Topical Vancomycin Prevent Periprosthetic Joint Infection in Primary Hip and Knee Arthroplasty Multicenter Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 035 povidone-iodine 175mL in 500 mL saline solution lavage left for 3 minutes following final implantation
Patients drawn by random numbers calculator will be administered with 10 g Vancomycin powder into the wound around the prosthesis and no suction will be used
Patients drawn by random numbers calculator will be administered with 10 g Vancomycin powder into the wound around the prosthesis and no suction will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None