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

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.
 
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

Tracking Information
First Submitted Date June 28, 2012
First Posted Date July 24, 2012
Last Update Posted Date March 20, 2015
Study Start Date September 2012
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 19, 2012)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01648088 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 19, 2012)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Detection of Staph Colonization in Pre-op Arthroplasty Patients
Official Title Enhanced Detection of Staphylococcus Aureus Colonization in Patients Undergoing Prosthetic Joint Implantation.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients undergoing prosthetic joint implantation.
Condition Surgical Site Infection
Intervention Not Provided
Study Groups/Cohorts Pre-op THA and TKA patients
Patients who are scheduled for total joint arthroplasty
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 19, 2012)
234
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All adult patients undergoing prosthetic joint implantation

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01648088
Other Study ID Numbers 569-11-EP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Angela Hewlett, MD, University of Nebraska
Study Sponsor University of Nebraska
Collaborators Not Provided
Investigators
Principal Investigator: Angela Hewlett, MD, MS University of Nebraska
PRS Account University of Nebraska
Verification Date March 2015