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OpenTrials
Completed

NCT Number: NCT01174212

Effect of Prophylactic Antibiotics on Intra-Operative Culture Results

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rush University Medical Center, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prophylactic Antibiotics

Procedure

Preoperative Antibiotics

Other names: Revision, Arthroplasty, Infection, Antibiotics, Ancef, Vancomycin

Control Antibiotics

Procedure

Antibiotics will be held until intraoperative cultures have been obtained.

Other names: Arthroplasty, Infection, Antibiotics

Primary outcomes

  1. Changes in cultures obtained preoperatively and intraoperatively

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Rothman Institute Orthopaedics

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Aug 3, 2010
Registry last updated
Aug 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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