Detection of Staph Colonization in Pre-op Arthroplasty Patients

Surgical Site Infection Clinical Trial

— Staph  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648088
• Other study ID #: 0569-11-EP
• Status: Completed
• Start date: September 1, 2012
• Est. completion date: March 1, 2015

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: March 1, 2015
• Est. primary completion date: March 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• All adult patients undergoing prosthetic joint implantation

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of surgical site infection.	The patient will be assessed by phone every 6 months for 2 years for development of infection at the surgical site.	Change in surgical site from baseline at 6 months, 1 year, 18 months and 2 years.
Secondary	Anatomical site(s) which are best utilized for swab cultures to detect S aureus.	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.	Up to 24 months post operatively.
Secondary	Post operative infection (s.aureus) development.	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.	Up to 24 months post operation.