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Intrawound Administration of Vancomycin in TKA

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intrawound administration of vancomycin after closure of the arthrotomy
Sponsored by
The Affiliated Hospital of Qingdao University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 50 and 80
  2. Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis

Exclusion Criteria:

  1. Diminished mental capacity
  2. Vancomycin allergy
  3. Chronic kidney disease stage III and stage IV

Sites / Locations

  • The affiliated hospital of Qingdao University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intrawound Administration of Vancomycin

Intrawound Administration of Vancomycin combined with epsilon-aminocaproic acid (EACA)

Arm Description

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. Then 20ml of normal saline was injected directly into the joint.

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. Then 4g (20ml) of epsilon-aminocaproic acid (EACA) was injected directly into the joint.

Outcomes

Primary Outcome Measures

Intra-articular vancomycin concentration
Serum vancomycin concentration
Renal function
blood urea nitrogen (BUN), creatinine (Cr), GFR
Blood loss

Secondary Outcome Measures

Full Information

First Posted
April 11, 2022
Last Updated
January 17, 2023
Sponsor
The Affiliated Hospital of Qingdao University
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1. Study Identification

Unique Protocol Identification Number
NCT05338021
Brief Title
Intrawound Administration of Vancomycin in TKA
Official Title
Serum and Wound Vancomycin Levels Following Intrawound Administration in Primary Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
September 7, 2022 (Actual)
Study Completion Date
September 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Hospital of Qingdao University

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intrawound Administration of Vancomycin
Arm Type
Experimental
Arm Description
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. Then 20ml of normal saline was injected directly into the joint.
Arm Title
Intrawound Administration of Vancomycin combined with epsilon-aminocaproic acid (EACA)
Arm Type
Experimental
Arm Description
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. Then 4g (20ml) of epsilon-aminocaproic acid (EACA) was injected directly into the joint.
Intervention Type
Procedure
Intervention Name(s)
Intrawound administration of vancomycin after closure of the arthrotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intra-articular vancomycin concentration
Time Frame
2 hours, 8 hours and 24 hours postoperatively
Title
Serum vancomycin concentration
Time Frame
2 hours, 8 hours and 24 hours postoperatively
Title
Renal function
Description
blood urea nitrogen (BUN), creatinine (Cr), GFR
Time Frame
Postoperative Day 1 and Day 3
Title
Blood loss
Time Frame
Postoperative Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuai Xiang, M.D.
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The affiliated hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
After completing this trial.

Learn more about this trial

Intrawound Administration of Vancomycin in TKA

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