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Staphylococcus Aureus Resistant to Methicillin (MRSA) Screening in Trauma (TRAUMASARM)

Primary Purpose

Emergencies

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GeneXpert®
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergencies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient treated in the trauma unit for fractures of the proximal femur belong to a social security scheme patient

Exclusion Criteria:

  • Minor patient
  • Presence of abrasions
  • MRSA history
  • Open fracture
  • Ongoing infectious process
  • Patients under judicial protection , guardianship
  • Pregnant or breastfeeding women
  • patient refusal to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    GeneXpert®

    Arm Description

    Detection is carried out after a sample within the patient's nasal cavity. The swab containing the sample is placed in the PLC GeneXpert® Cepheid . The analysis takes one hour . The results leave automatically.

    Outcomes

    Primary Outcome Measures

    Prevalence of Staphylococcus aureus resistant to methicillin nasal carriage in the population supported to trauma emergencies
    To evaluate the prevalence of Staphylococcus aureus resistant to methicillin nasal carriage in the population supported to trauma emergencies

    Secondary Outcome Measures

    Full Information

    First Posted
    July 20, 2016
    Last Updated
    November 9, 2020
    Sponsor
    University Hospital, Toulouse
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02842710
    Brief Title
    Staphylococcus Aureus Resistant to Methicillin (MRSA) Screening in Trauma
    Acronym
    TRAUMASARM
    Official Title
    Staphylococcus Aureus Resistant to Methicillin (MRSA) Screening in Trauma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    the study did not start due to a lack of staff
    Study Start Date
    June 4, 2016 (Actual)
    Primary Completion Date
    December 15, 2018 (Actual)
    Study Completion Date
    December 15, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Toulouse

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The main objective of this study and to know the incidence of healthy carriers of Staphylococcus aureus resistant méti- patients supported for fracture of the proximal femur . This assessment will be made preoperatively by a nasal sampling and analysis through it by rapid Polymerase Chain Reaction method GeneXpert® .
    Detailed Description
    There are 85,000 fractures of the upper extremity in France each year. This is a frequent pathology in fragile patients. The characteristics in terms of comorbidities, age, sex and survival are well known from the literature. While secondary mechanical complications to surgery, hovering around 6 to 8%, mortality at one year is very high (around 25%). Postoperative infection after a fracture of the upper end of the femur ranges from 2 to 8% depending on the series. This complication is responsible for morbidity and excess mortality linked to the need for revision surgery, prolongation of hospitalization and antibiotic treatment. In elective surgery, detection of Staphylococcus aureus resistant to methicillin is systematic and recommended in many countries, preoperative level of the nasal cavity. Parvizi then Goya believe that this port increased from four to nine times the occurrence of infection at the surgical site. Various epidemiological studies have shown the presence of Staphylococcus aureus in over 30% of patients. This prevalence is lower in the French population. An estimated 70% the proportion of Staphylococcus aureus in the periprosthetic infections, and 30% related specifically to the methicillin-resistant Staphylococcus aureus. Today there is no consensus on what to have vis-à-vis the detection of a hand and the other hand treatment of patients. The healthy carrier in the population overtake admitted to the trauma unit is unclear. It is therefore necessary to know these effects among patients with multiple pathologies. For methods of detection, the usual system and directed by swabbing and cultured with 90% sensitivity specificity of 100%. The demoyens existence of early detection as GeneXpert® Cepheid® lets get this result is in an hour with a specificity of 98% and a sensitivity of 100%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Emergencies

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    GeneXpert®
    Arm Type
    Experimental
    Arm Description
    Detection is carried out after a sample within the patient's nasal cavity. The swab containing the sample is placed in the PLC GeneXpert® Cepheid . The analysis takes one hour . The results leave automatically.
    Intervention Type
    Device
    Intervention Name(s)
    GeneXpert®
    Intervention Description
    Detection is carried out after a sample within the patient's nasal cavity. The swab containing the sample is placed in the PLC GeneXpert® Cepheid . The analysis takes one hour . The results leave automatically.
    Primary Outcome Measure Information:
    Title
    Prevalence of Staphylococcus aureus resistant to methicillin nasal carriage in the population supported to trauma emergencies
    Description
    To evaluate the prevalence of Staphylococcus aureus resistant to methicillin nasal carriage in the population supported to trauma emergencies
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient treated in the trauma unit for fractures of the proximal femur belong to a social security scheme patient Exclusion Criteria: Minor patient Presence of abrasions MRSA history Open fracture Ongoing infectious process Patients under judicial protection , guardianship Pregnant or breastfeeding women patient refusal to participate in the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nicolas Reina, Dr
    Organizational Affiliation
    University Hospital, Toulouse
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Staphylococcus Aureus Resistant to Methicillin (MRSA) Screening in Trauma

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