Effect of Prophylactic Antibiotics on Intra-Operative Culture Results

Phase 4

Completed

• Conditions: Infection; Arthroplasty
• Interventions: Procedure: Prophylactic Antibiotics; Procedure: Control Antibiotics

• Registration Number: NCT01174212
• Lead Sponsor: Rush University Medical Center

Brief Summary

Subjects will be consented and then determined randomly whether they will receive antibiotics prior to their surgery or during their surgery. Each patient will have cultures taken before and during their surgery from the infected hip or knee. Results will be compared after completion of the study.

Detailed Description

It is unknown whether giving pre-operative antibiotics affects the results of intraoperative bacterial cultures. This is an important question as antibiotics are often not given prior to surgery out of concern that accurate culture results will not be obtained. It is important to obtain accurate cultures so that targeted antibiotic therapy can be used. However, delaying the administration of antibiotics also delays the onset of treatment. Currently, the optimal course of action is unknown. The purpose of this study is to resolve this issue and determine if prophylactic antibiotics affect intra-operative culture results in patients undergoing revision hip or knee arthroplasty surgery for infection.

This is a prospective randomized clinical study to determine if prophylactic antibiotics affect intra-operative culture results in patients undergoing revision hip or knee arthroplasty surgery for infection. Pre-operatively, patients will have their affected joint aspirated and this fluid will be sent for cultures. Patients are then randomized to receive prophylactic antibiotics (Vancomycin and Ancef) within one hour prior to surgery or to have pre-operative antibiotics withheld. Every patient then has their affected joint cultured intra-operatively. All samples will be evaluated for the presence of aerobic bacteria, anaerobic bacteria, mycobacteria, and fungus. Pre-operative and post-operative cultures in both study populations are compared to determine the effects of pre-operative antibiotics.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-27
• Study First Submitted QC: 2010-08-02
• Study First Posted: 2010-08-03
• Primary Completion: 2011-07
• Study Completion: 2012-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-29
• Last Update Posted: 2012-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• prior arthroplasty surgery of the hip or knee
• presentation to clinic with infected joint
• scheduled for revision surgery

Exclusion Criteria

• patients who have received antibiotics for any reason within 4 weeks of their pre-operative culture
• infected native joints
• septic patients
• refusal of participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Prophylactic Antibiotics	Patients receiving antibiotics approximately 1 hour prior to incision are considered to be in the experimental group of this study.
Control	Control Antibiotics	Control group is to receive no antibiotics until the intraoperative cultures have been obtained.

Primary Outcome Measures

Name	Time	Method
Changes in cultures obtained preoperatively and intraoperatively	1 year	Patients suspected of having an infected total hip or knee replacement in the post-operative period will be evaluated clinically. Preoperative and intraoperative revision cultures will be compared.

Trial Locations

Locations (2)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States