Effect of Prophylactic Antibiotics on Intra-Operative Culture Results

NCT01174212 | Completed Phase 4 DMC

• 1 other identifier: 10020102
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Infection; Arthroplasty

Keywords

revision; infection; knee; hip; replacement; antibiotics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Control

OTHER

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

Procedure: Control Antibiotics

Interventions

Prophylactic Antibiotics PROCEDURE

Preoperative Antibiotics

Also known as: Revision, Arthroplasty, Infection, Antibiotics, Ancef, Vancomycin

Experimental

Control Antibiotics PROCEDURE

Antibiotics will be held until intraoperative cultures have been obtained.

Also known as: Arthroplasty, Infection, Antibiotics

Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• prior arthroplasty surgery of the hip or knee
• presentation to clinic with infected joint
• scheduled for revision surgery

You may not qualify if:

• patients who have received antibiotics for any reason within 4 weeks of their pre-operative culture
• infected native joints
• septic patients
• refusal of participation

Sponsors & Collaborators

• Rush University Medical Center: lead
• Rothman Institute Orthopaedics: collaborator

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Related 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.

  PMID: 19669849 BACKGROUND

MeSH Terms

Conditions

Infections

Interventions

Second-Look Surgery; Arthroplasty; Anti-Bacterial Agents; Cefazolin; Vancomycin

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Orthopedic Procedures; Plastic Surgery Procedures; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Craig Della Valle, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: August 3, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2012
• Last Updated: August 31, 2012

Record last verified: 2012-08

Locations

US (2)