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Effect of Prophylactic Antibiotics on Intra-Operative Culture Results

Primary Purpose

Infection, Arthroplasty

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prophylactic Antibiotics
Control Antibiotics
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection focused on measuring revision, infection, knee, hip, replacement, antibiotics

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rush University Medical Center
  • Rothman Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental

Control

Arm Description

Patients receiving antibiotics approximately 1 hour prior to incision are considered to be in the experimental group of this study.

Control group is to receive no antibiotics until the intraoperative cultures have been obtained.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 27, 2010
Last Updated
August 29, 2012
Sponsor
Rush University Medical Center
Collaborators
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT01174212
Brief Title
Effect of Prophylactic Antibiotics on Intra-Operative Culture Results
Official Title
Effect of Prophylactic Antibiotics on Intra-Operative Culture Results
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
Rothman Institute Orthopaedics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Arthroplasty
Keywords
revision, infection, knee, hip, replacement, antibiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients receiving antibiotics approximately 1 hour prior to incision are considered to be in the experimental group of this study.
Arm Title
Control
Arm Type
Other
Arm Description
Control group is to receive no antibiotics until the intraoperative cultures have been obtained.
Intervention Type
Procedure
Intervention Name(s)
Prophylactic Antibiotics
Other Intervention Name(s)
Revision, Arthroplasty, Infection, Antibiotics, Ancef, Vancomycin
Intervention Description
Preoperative Antibiotics
Intervention Type
Procedure
Intervention Name(s)
Control Antibiotics
Other Intervention Name(s)
Arthroplasty, Infection, Antibiotics
Intervention Description
Antibiotics will be held until intraoperative cultures have been obtained.
Primary Outcome Measure Information:
Title
Changes in cultures obtained preoperatively and intraoperatively
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Della Valle, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19669849
Citation
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.
Results Reference
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Effect of Prophylactic Antibiotics on Intra-Operative Culture Results

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