Intrawound Administration of Vancomycin in THA

NCT05338008 | Completed

• 1 other identifier: AHQingdao VancoTHA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 hip arthroplasty.

Conditions

Hip

Outcome Measures

Primary Outcomes (4)

• 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

  blood urea nitrogen (BUN), creatinine (Cr), GFR

  Postoperative Day 1 and Day 3

• Blood loss

  Postoperative Day 3

Study Arms (3)

Intrawound Administration of Vancomycin

EXPERIMENTAL

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.

Procedure: Intrawound administration of vancomycin after closure of the arthrotomy

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

EXPERIMENTAL

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.

Procedure: Intrawound administration of vancomycin after closure of the arthrotomy

Intrawound Administration of epsilon-aminocaproic acid (EACA)

NO INTERVENTION

After closure of the arthrotomy, 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.

Interventions

Intrawound administration of vancomycin after closure of the arthrotomy PROCEDURE

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18;
• Total hip arthroplasty for advanced hip diseases including femoral neck fracture, developmental dysplasia of hip, and osteonecrosis of the femoral head.

You may not qualify if:

• Diminished mental capacity
• Vancomycin allergy
• Chronic kidney disease stage III and stage IV

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The affiliated hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Study Officials

• Shuai Xiang, M.D.

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 20, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After completing the trial.

Locations

CN (1)