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Effect of Prophylactic Antibiotics on Intra-Operative Culture Results

NCT ID: NCT01174212

Last Updated: 2012-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Infection Arthroplasty

Keywords

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revision infection knee hip replacement antibiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

Prophylactic Antibiotics

Intervention Type PROCEDURE

Preoperative Antibiotics

Control

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

Group Type OTHER

Control Antibiotics

Intervention Type PROCEDURE

Antibiotics will be held until intraoperative cultures have been obtained.

Interventions

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Prophylactic Antibiotics

Preoperative Antibiotics

Intervention Type PROCEDURE

Control Antibiotics

Antibiotics will be held until intraoperative cultures have been obtained.

Intervention Type PROCEDURE

Other Intervention Names

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Revision Arthroplasty Infection Antibiotics Ancef Vancomycin Arthroplasty Infection Antibiotics

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Craig J Delle Valle

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Craig Della Valle, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Rothman Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Burnett RS, Aggarwal A, Givens SA, McClure JT, Morgan PM, Barrack RL. Prophylactic antibiotics do not affect cultures in the treatment of an infected TKA: a prospective trial. Clin Orthop Relat Res. 2010 Jan;468(1):127-34. doi: 10.1007/s11999-009-1014-4. Epub 2009 Aug 11.

Reference Type BACKGROUND
PMID: 19669849 (View on PubMed)

Other Identifiers

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10020102

Identifier Type: -

Identifier Source: org_study_id