Intrawound Administration of Vancomycin in THA

Sponsor

The Affiliated Hospital of Qingdao University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05338008

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip	Procedure: Intrawound administration of vancomycin after closure of the arthrotomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

Intra-articular vancomycin concentration [2 hours, 8 hours and 24 hours postoperatively]
Serum vancomycin concentration [2 hours, 8 hours and 24 hours postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The affiliated hospital of Qingdao University	Qingdao	Shandong	China	266000

Sponsors and Collaborators

The Affiliated Hospital of Qingdao University

Investigators

Principal Investigator: Shuai Xiang, M.D., The Affiliated Hospital of Qingdao University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiang Shuai, MD, Principal Investigator, The Affiliated Hospital of Qingdao University

ClinicalTrials.gov Identifier:

NCT05338008

Other Study ID Numbers:

AHQingdao VancoTHA

First Posted:

Apr 20, 2022

Last Update Posted:

Jul 25, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vancomycin

Study Results

No Results Posted as of Jul 25, 2022