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Withdrawn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

About this trial
This is an interventional prevention trial for Emergencies
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
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
NCT ID
NCT02842710
First Posted
July 20, 2016
Last Updated
November 9, 2020
Sponsor
University Hospital, Toulouse
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Withdrawn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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