Intrawound Administration of Vancomycin in TKA

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: Intrawound administration of vancomycin after closure of the arthrotomy

• Registration Number: NCT05338021
• Lead Sponsor: The Affiliated Hospital of Qingdao University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-17
• Study First Posted: 2022-04-20
• Study Start: 2022-05-25
• Primary Completion: 2022-09-07
• Study Completion: 2022-09-07
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrawound Administration of Vancomycin	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. Then 20ml of normal saline was injected directly into the joint.
Intrawound Administration of Vancomycin combined with epsilon-aminocaproic acid (EACA)	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. Then 4g (20ml) of epsilon-aminocaproic acid (EACA) was injected directly into the joint.

Primary Outcome Measures

Name	Time	Method
Intra-articular vancomycin concentration	2 hours, 8 hours and 24 hours postoperatively
Serum vancomycin concentration	2 hours, 8 hours and 24 hours postoperatively
Renal function	Postoperative Day 1 and Day 3	blood urea nitrogen (BUN), creatinine (Cr), GFR
Blood loss	Postoperative Day 3

Trial Locations

Locations (1)

The affiliated hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China