Intrawound Administration of Vancomycin in TKA
Sponsor
The Affiliated Hospital of Qingdao University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05338021
Collaborator
(none)
120
1
1
7.2
16.6
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total knee arthroplasty.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Serum and Wound Vancomycin Levels Following Intrawound Administration in Primary Total Knee Arthroplasty
Actual Study Start Date
:
May 25, 2022
Anticipated Primary Completion Date
:
Dec 31, 2022
Anticipated Study Completion Date
:
Dec 31, 2022
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Intrawound Administration of Vancomycin After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. |
Procedure: Intrawound administration of vancomycin after closure of the arthrotomy
After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle.
|
Outcome Measures
Primary Outcome Measures
- Intra-articular vancomycin concentration [2 hours, 8 hours and 24 hours postoperatively]
- Serum vancomycin concentration [2 hours, 8 hours and 24 hours postoperatively]
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age between 50 and 80
-
Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis
Exclusion Criteria:
-
Diminished mental capacity
-
Vancomycin allergy
-
Chronic kidney disease stage III and stage IV
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | The affiliated hospital of Qingdao University | Qingdao | Shandong | China | 266000 |
Sponsors and Collaborators
- The Affiliated Hospital of Qingdao University
Investigators
- Principal Investigator: Shuai Xiang, M.D., The Affiliated Hospital of Qingdao University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Xiang Shuai, MD,
Principal Investigator,
The Affiliated Hospital of Qingdao University
ClinicalTrials.gov Identifier:
NCT05338021
Other Study ID Numbers:
- AHQingdao VancoTKA
First Posted:
Apr 20, 2022
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: