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Staphylococcus Aureus Resistant to Methicillin (MRSA) Screening in Trauma

NCT ID: NCT02842710

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-04

Study Completion Date

2018-12-15

Brief Summary

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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

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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%.

Conditions

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Emergencies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

GeneXpert®

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Reina, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Other Identifiers

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RC31/15/7856

Identifier Type: -

Identifier Source: org_study_id