COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk Factors for Staphylococcus Aureus Surgical Site Infections in Orthopedic and Trauma Surgery (ISO)

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: NCT03040960
Recruitment Status : Unknown
Verified October 2017 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
First Posted : February 2, 2017
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
The most commonly identified organism for Surgical Site Infection (SSI) in orthopedic surgery is Staphylococcus aureus but risk factors for mono microbial S.aureus SSI are not well-known. The aim of this study was to evaluated the incidence rate of S. aureus SSI over the years and risk factors of these infections in a french University Hospital.

Condition or disease
Staphylococcus Aureus Surgical Wound Infection Orthopedic Disorder Traumatology

Detailed Description:

Surgical site infections (SSI) in orthopedic surgery are responsible for reduced quality of life, increased length of hospital stay and costs. The most commonly identified organism is Staphylococcus aureus but risk factors for mono microbial S.aureus SSI are not well-known.The aim of this study was to evaluate the incidence rate trend of S. aureus SSI over the years and risk factors of theses infections in a french University Hospital.

The knowledge obtained by this study will enable identification of the surgical patients most at risk of developping S. aureus SSI, and who would probably benefit most from new interventions given prophylactically and specifically to prevent S. aureus infections.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Risk Factors for Staphylococcus Aureus Surgical Site Infections in Orthopedic and Trauma Surgery
Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Risk factors of S. aureus surgical site infections. [ Time Frame: up to 1 year following surgery ]
    univariate analysis of potential risk factors. Data with p value less than 0.1 were included in a logistic regression model


Secondary Outcome Measures :
  1. The incidence rate trend of S. aureus SSI over the year. [ Time Frame: from january 1st 2012 to april 30th 2015 ]
    linear regression slope test of S. aureus SSI incidence rates by years



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing orthopedic or traumatologiy surgeries in Grenoble university hospital
Criteria

Inclusion Criteria:

  • orthopedic or traumatology surgeries performed in Grenoble University Hospital,
  • from january 1st 2012 to april 30th 2015,
  • the subject is undergoing one of the following surgical procedures : knee and hip arthroplasties, osteosynthesis of proximal femur and other osteosynthesis except skull and spine.
  • the subject is 16 years of age or older

Exclusion Criteria:

  • non orthopedic or trauma surgery performed in Grenoble University Hospital,
  • spine surgeries,
  • surgeries of the hand, scaphoid and carpal bones.

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): NCT03040960


Contacts
Layout table for location contacts
Contact: Caroline Landelle, PH 0033476765643 clandelle@chu-grenoble.fr

Locations
Layout table for location information
France
University Hospital, Grenoble Alpes Recruiting
Grenoble, France, 38043
Contact: Caroline Landelle    0033476765643    clandelle@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Layout table for investigator information
Principal Investigator: Caroline landelle, PH University Hospital, Grenoble
Publications:
Layout table for additonal information
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03040960    
Other Study ID Numbers: 38RC16.223
1985246 ( Other Identifier: CNIL )
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
infection
wound infection
surgical wound infection
Staphylococcal infections
wound and injuries
postoperative complications
Gram-positive bacterial infections
bacterial infections
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Musculoskeletal Diseases
Surgical Wound
Postoperative Complications
Pathologic Processes
Wounds and Injuries