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Effect of Prophylactic Antibiotics on Intra-Operative Culture Results

This study has been completed.
Sponsor:
Collaborator:
Rothman Institute Orthopaedics
Information provided by (Responsible Party):
Craig J Delle Valle, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01174212
First received: July 27, 2010
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Infection
Arthroplasty
Procedure: Prophylactic Antibiotics
Procedure: Control Antibiotics
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Prophylactic Antibiotics on Intra-Operative Culture Results

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Changes in cultures obtained preoperatively and intraoperatively [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 65
Study Start Date: July 2010
Study Completion Date: July 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174212

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rush University Medical Center
Rothman Institute Orthopaedics
Investigators
Principal Investigator: Craig Della Valle, MD Rush University Medical Center
  More Information

Publications:
Responsible Party: Craig J Delle Valle, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01174212     History of Changes
Other Study ID Numbers: 10020102
Study First Received: July 27, 2010
Last Updated: August 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
revision
infection
knee
hip
replacement
antibiotics

Additional relevant MeSH terms:
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014