Intrawound Administration of Vancomycin in TKA

Qingdao University

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Procedure: Intrawound administration of vancomycin after closure of the arthrotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05338021

AHQingdao VancoTKA

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Intrawound Administration of Vancomycin

Experimental group

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.

Treatment:

Procedure: Intrawound administration of vancomycin after closure of the arthrotomy

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

Experimental group

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.

Treatment:

Procedure: Intrawound administration of vancomycin after closure of the arthrotomy