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

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ClinicalTrials.gov Identifier: NCT02842710
Recruitment Status : Withdrawn (the study did not start due to a lack of staff)
First Posted : July 25, 2016
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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® .


Condition or disease Intervention/treatment Phase
Emergencies Device: GeneXpert® Not Applicable

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%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Staphylococcus Aureus Resistant to Methicillin (MRSA) Screening in Trauma
Actual Study Start Date : June 4, 2016
Actual Primary Completion Date : December 15, 2018
Actual Study Completion Date : December 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GeneXpert®
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.
Device: GeneXpert®
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 Measures :
  1. Prevalence of Staphylococcus aureus resistant to methicillin nasal carriage in the population supported to trauma emergencies [ Time Frame: 12 months ]
    To evaluate the prevalence of Staphylococcus aureus resistant to methicillin nasal carriage in the population supported to trauma emergencies



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02842710


Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Nicolas Reina, Dr University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02842710    
Other Study ID Numbers: RC31/15/7856
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes