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Detection of Staph Colonization in Pre-op Arthroplasty Patients

Enhanced Detection of Staphylococcus Aureus Colonization in Patients Undergoing Prosthetic Joint Implantation.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01648088
Acronym
Staph
Enrollment
234
Registered
2012-07-24
Start date
2012-09-01
Completion date
2015-03-01
Last updated
2023-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

Keywords

staphylococcus aureus, prosthetic joint implantation

Brief summary

This study will evaluate which body site(s) provide the best source of possible staph presence in participants undergoing total joint arthroplasty. If the pre-operative cultures indicate staph presence, an Infectious Disease specialist will be consulted for standard of medical care consultation and treatment management. Participants will be followed for 2 years post-implantation of prosthetic joint to monitor development of prosthetic joint infection.

Detailed description

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.

Interventions

None listed

Sponsors

University of Nebraska
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* All adult patients undergoing prosthetic joint implantation

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Development of surgical site infection.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

MeasureTime frameDescription
Anatomical site(s) which are best utilized for swab cultures to detect S aureus.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.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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026