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S. Aureus Translocation From Skin and Nose to Periprosthetic Tissues

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ClinicalTrials.gov Identifier: NCT04666532
Recruitment Status : Enrolling by invitation
First Posted : December 14, 2020
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Brief Summary:

Surgical site infections (SSI) are a significant clinical issue that requires the use of a great amount of resources. In particular, periprosthetic joint infections (PJIs) have potentially catastrophic effects on patients' health-related quality of life, function, healthcare costs, outcomes and medical implications. National surveillance estimates may under-report the true incidence and when considering the large number of total hip (THA) and total knee arthroplasty (TKA) procedures performed each year.

Patients who have a high-level of nasal bacteria have been found to have a risk of surgical site infection that is three to six times the risk compared with noncarriers and low-level carriers. The association between a patient's nasal carriage of S. aureus, specifically MRSA, and PJI has been demonstrated in a systematic review and confirmed in recent cohort studies. While this association seems to be well accepted, no mechanistic explanation has been provided for this association.


Condition or disease
Staphylococcus Aureus

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Staphylococcus Aureus Translocation From Skin and Nose to Periprosthetic Tissues
Actual Study Start Date : October 22, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021



Primary Outcome Measures :
  1. S. aureus Culture and Next Generation Sequencing [ Time Frame: 1 day ]
    Diagnostic performance of molecular and culture techniques for S. aureus screening using nasal and groin swabs to determine whether the S. aureus retrieved on the skin and nares of patients who develop a joint infection is identical to the bacteria found in the wound of the PJI



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants who are undergoing revision total knee or hip arthroplasty by one of the joints surgeons at Rothman Orthopaedics
Criteria

Inclusion Criteria:

  • All patients undergoing revision total knee or total hip arthroplasty at our institution will be eligible

Exclusion Criteria:

  • Patients included in other prospective studies

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): NCT04666532


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04666532    
Other Study ID Numbers: JPAR20D165 FARE
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections