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

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® .

Study Overview

• Status: Withdrawn
• Conditions: Emergencies
• Intervention / Treatment: Device: 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%.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 4, 2016
• Primary Completion (ACTUAL): December 15, 2018
• Study Completion (ACTUAL): December 15, 2018

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (ESTIMATE): July 25, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: RC31/15/7856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO