Intrawound Administration of Vancomycin in THA

Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05338008
• Other study ID #: AHQingdao VancoTHA
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 hip arthroplasty.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age over 18;

2. Total hip arthroplasty for advanced hip diseases including femoral neck fracture, developmental dysplasia of hip, and osteonecrosis of the femoral head.

Exclusion Criteria:

1. Diminished mental capacity

2. Vancomycin allergy

3. Chronic kidney disease stage III and stage IV

Related Conditions & MeSH terms

• Hip

Intervention

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.

Locations

Country	Name	City	State
China	The affiliated hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-articular vancomycin concentration		2 hours, 8 hours and 24 hours postoperatively
Primary	Serum vancomycin concentration		2 hours, 8 hours and 24 hours postoperatively
Primary	Renal function	blood urea nitrogen (BUN), creatinine (Cr), GFR	Postoperative Day 1 and Day 3
Primary	Blood loss		Postoperative Day 3