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Detection of Staph Colonization in Pre-op Arthroplasty Patients (Staph)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 24, 2012
Last Update Posted: March 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Angela Hewlett, MD, University of Nebraska
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.

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:

Further study details as provided by Angela Hewlett, MD, 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. ]
    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. ]
    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. ]
    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.

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


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing prosthetic joint implantation.

Inclusion Criteria:

  • All adult patients undergoing prosthetic joint implantation

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648088

United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Principal Investigator: Angela Hewlett, MD, MS University of Nebraska
  More Information

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
First Submitted: June 28, 2012
First Posted: July 24, 2012
Last Update Posted: March 20, 2015
Last Verified: March 2015

Keywords provided by Angela Hewlett, MD, University of Nebraska:
staphylococcus aureus
prosthetic joint implantation

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes