Intrawound Administration of Vancomycin in THA

NCT ID: NCT05338008

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intrawound Administration of Vancomycin

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.

Group Type: EXPERIMENTAL

Intrawound administration of vancomycin after closure of the arthrotomy

Intervention Type: 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 combined with epsilon-aminocaproic acid (EACA)

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.

Group Type: EXPERIMENTAL

Intrawound administration of vancomycin after closure of the arthrotomy

Intervention Type: 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 epsilon-aminocaproic acid (EACA)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

Xiang Shuai, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuai Xiang, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Qingdao University

Locations

The affiliated hospital of Qingdao University

Qingdao, Shandong, China

Countries

China

Other Identifiers

AHQingdao VancoTHA

Identifier Type: -

Identifier Source: org_study_id