Effect of Prophylactic Antibiotics on Intra-Operative Culture Results

Infection Clinical Trial

Official title:

Effect of Prophylactic Antibiotics on Intra-Operative Culture Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174212
• Other study ID #: 10020102
• Status: Completed
• Phase: Phase 4
• First received: July 27, 2010
• Last updated: August 29, 2012
• Start date: July 2010
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty
• Infection

Intervention

Procedure:
• Prophylactic Antibiotics
Preoperative Antibiotics
• Control Antibiotics
Antibiotics will be held until intraoperative cultures have been obtained.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cultures obtained preoperatively and intraoperatively	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.	1 year	No