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S. Aureus Translocation From Skin and Nose to Periprosthetic Tissues

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: 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

Tracking Information
First Submitted Date December 8, 2020
First Posted Date December 14, 2020
Last Update Posted Date December 14, 2020
Actual Study Start Date October 22, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 8, 2020)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title S. Aureus Translocation From Skin and Nose to Periprosthetic Tissues
Official Title Staphylococcus Aureus Translocation From Skin and Nose to Periprosthetic Tissues
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Staphylococcus Aureus
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Enrolling by invitation
Actual Enrollment
 (submitted: December 8, 2020)
200
Original Actual Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 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 NCT04666532
Other Study ID Numbers JPAR20D165 FARE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor Rothman Institute Orthopaedics
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date December 2020