Effect of Prophylactic Antibiotics on Intra-Operative Culture Results
Information source: Rush University Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection; Arthroplasty
Intervention: Prophylactic Antibiotics (Procedure); Control Antibiotics (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: Rush University Medical Center Official(s) and/or principal investigator(s): Craig Della Valle, MD, Principal Investigator, Affiliation: Rush University Medical Center
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.
Clinical Details
Official title: Effect of Prophylactic Antibiotics on Intra-Operative Culture Results
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Changes in cultures obtained preoperatively and intraoperatively
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
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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
Locations and Contacts
Rush University Medical Center, Chicago, Illinois 60612, United States
Rothman Institute, Philadelphia, Pennsylvania 19107, United States
Additional Information
Related publications: 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.
Starting date: July 2010
Last updated: August 29, 2012
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