Effect of Prophylactic Antibiotics on Intra-Operative Culture Results

Sponsor

Rush University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01174212

Collaborator

Rothman Institute Orthopaedics (Other)

Enrollment

Locations

Arms

Duration (Months)

32.5

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection Arthroplasty	Procedure: Prophylactic Antibiotics Procedure: Control Antibiotics	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Effect of Prophylactic Antibiotics on Intra-Operative Culture Results

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Patients receiving antibiotics approximately 1 hour prior to incision are considered to be in the experimental group of this study.	Procedure: Prophylactic Antibiotics Preoperative Antibiotics Other Names: Revision Arthroplasty Infection Antibiotics Ancef Vancomycin
Other: Control Control group is to receive no antibiotics until the intraoperative cultures have been obtained.	Procedure: Control Antibiotics Antibiotics will be held until intraoperative cultures have been obtained. Other Names: Arthroplasty Infection Antibiotics

Arm

Intervention/Treatment

Experimental: Experimental

Patients receiving antibiotics approximately 1 hour prior to incision are considered to be in the experimental group of this study.

Procedure: Prophylactic Antibiotics

Preoperative Antibiotics

Other Names:

Revision

Arthroplasty

Infection

Antibiotics

Ancef

Vancomycin

Other: Control

Control group is to receive no antibiotics until the intraoperative cultures have been obtained.

Procedure: Control Antibiotics

Antibiotics will be held until intraoperative cultures have been obtained.

Other Names:

Arthroplasty

Infection

Antibiotics

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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