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Detection of Staph Colonization in Pre-op Arthroplasty Patients

This study is not yet open for participant recruitment.
Verified August 2012 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
Angela Hewlett, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01648088
First received: June 28, 2012
Last updated: August 3, 2012
Last verified: August 2012
History of Changes
  Purpose

The presence of Staph in/on a patient who will undergo total joint replacement is a risk in that the patient could go on to develop infection at the surgery site after surgery. The purpose of this study is to evaluate if it is beneficial to to administer a questionnaire and obtain cultures from various body sites from patients prior to surgery and also to determine which body site(s) provide the best source of possible staph presence. If the pre operative cultures indicate staph is present, an Infectious Disease specialist will be consulted for standard of medical care consultation and treatment management. All patients scheduled to have total joint arthroplasty are eligible to participate. The research team will follow the study patients for 2 years after they undergo prosthetic joint implantation to monitor for development of prosthetic joint infection.


Condition
Surgical Site Infection

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Enhanced Detection of Staphylococcus Aureus Colonization in Patients Undergoing Prosthetic Joint Implantation.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Development of surgical site infection. [ Time Frame: Change in surgical site from baseline at 6 months, 1 year, 18 months and 2 years. ] [ Designated as safety issue: No ]
    The patient will be assessed by phone every 6 months for 2 years for development of infection at the surgical site.


Secondary Outcome Measures:
  • Anatomical site(s) which are best utilized for swab cultures to detect S aureus. [ Time Frame: Up to 24 months post operatively. ] [ Designated as safety issue: No ]
    We hope to determine which anatomical site(s) are best utilized for swab cultures to detect S aureus colonization in patients undergoing prosthetic joint replacement. We will collect data on infection development for up to 2 years post operatively.

  • Post operative infection (s.aureus) development. [ Time Frame: Up to 24 months post operation. ] [ Designated as safety issue: No ]
    We will measure at what percentage a pre-operative questionnaire accurately predicts if a patient will develop an infection (s.aureus) between day one and 2 years post operatively.


Estimated Enrollment: 234
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pre-op THA and TKA patients
Patients who are scheduled for total joint arthroplasty

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All patients undergoing prosthetic joint implantation.

Criteria

Inclusion Criteria:

  • All adult patients undergoing prosthetic joint implantation

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648088

Locations
United States, Nebraska
University of Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68198
Contact: Dana Schwarz, RN, MS     402-559-4167     dschwarz@unmc.edu    
Principal Investigator: Angela Hewlett, MD, MS            
Sub-Investigator: Curtis Hartman, MD            
Sub-Investigator: Beau Konigsberg, MD            
Sub-Investigator: Kevin Garvin, MD            
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Angela Hewlett, MD, MS University of Nebraska
  More Information

No publications provided

Responsible Party: Angela Hewlett, MD, MD,MS,Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01648088     History of Changes
Other Study ID Numbers: 569-11-EP
Study First Received: June 28, 2012
Last Updated: August 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
staphylococcus aureus
prosthetic joint implantation

ClinicalTrials.gov processed this record on May 23, 2013