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

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ClinicalTrials.gov Identifier: NCT01648088
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):
Angela Hewlett, MD, University of Nebraska

Brief Summary:
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 or disease
Surgical Site Infection

Study Type : Observational
Actual Enrollment : 234 participants
Time Perspective: Cross-Sectional
Official Title: Enhanced Detection of Staphylococcus Aureus Colonization in Patients Undergoing Prosthetic Joint Implantation.
Study Start Date : September 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Pre-op THA and TKA patients
Patients who are scheduled for total joint arthroplasty



Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.



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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.
Criteria

Inclusion Criteria:

  • All adult patients undergoing prosthetic joint implantation

Exclusion Criteria:


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


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

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 Posted: July 24, 2012    Key Record Dates
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
Infection
Postoperative Complications
Pathologic Processes