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Intrawound Administration of Vancomycin in TKA

Serum and Wound Vancomycin Levels Following Intrawound Administration in Primary Total Knee Arthroplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05338021
Enrollment
100
Registered
2022-04-20
Start date
2022-05-25
Completion date
2022-09-07
Last updated
2023-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

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.

Sponsors

The Affiliated Hospital of Qingdao University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intra-articular vancomycin concentration2 hours, 8 hours and 24 hours postoperatively
Serum vancomycin concentration2 hours, 8 hours and 24 hours postoperatively
Renal functionPostoperative Day 1 and Day 3blood urea nitrogen (BUN), creatinine (Cr), GFR
Blood lossPostoperative Day 3

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026