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Completed

NCT Number: NCT01648088

Detection of Staph Colonization in Pre-op Arthroplasty Patients

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.

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Key information

Conditions

Surgical Site Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Staphylococcal Infections Surgical Wound Infection Wound Infection

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All adult patients undergoing prosthetic joint implantation

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

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

Acronym: Staph

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 24, 2012
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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