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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

Page last updated: August 20, 2015

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