Detection of Staph Colonization in Pre-op Arthroplasty Patients
Verified August 2012 by University of Nebraska
Information provided by (Responsible Party):
Angela Hewlett, MD, University of Nebraska
First received: June 28, 2012
Last updated: August 3, 2012
Last verified: August 2012
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.
||Time Perspective: Cross-Sectional
||Enhanced Detection of Staphylococcus Aureus Colonization in Patients Undergoing Prosthetic Joint Implantation.
Primary Outcome Measures:
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2015 (Final data collection date for primary outcome measure)
Pre-op THA and TKA patients
Patients who are scheduled for total joint arthroplasty
|Ages Eligible for Study:
||19 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
All patients undergoing prosthetic joint implantation.
- All adult patients undergoing prosthetic joint implantation
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648088
|University of Nebraska Medical Center
|Omaha, Nebraska, United States, 68198 |
|Contact: Dana Schwarz, RN, MS 402-559-4167 firstname.lastname@example.org |
|Principal Investigator: Angela Hewlett, MD, MS |
|Sub-Investigator: Curtis Hartman, MD |
|Sub-Investigator: Beau Konigsberg, MD |
|Sub-Investigator: Kevin Garvin, MD |
University of Nebraska
||Angela Hewlett, MD, MS
||University of Nebraska
No publications provided
||Angela Hewlett, MD, MD,MS,Assistant Professor, University of Nebraska
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 28, 2012
||August 3, 2012
||United States: Institutional Review Board
Keywords provided by University of Nebraska:
ClinicalTrials.gov processed this record on November 27, 2014
prosthetic joint implantation