Grinding Versus Standard Methods for the Treatment of Per-operative Bacteriological Samples Associated With Osteo-articular Sepsis

Centre Hospitalier Universitaire de Nīmes122 enrolled

Overview

The main objective of this study was to compare the diagnostic capability (sensitivity and specificity) of standard bacteriological analysis made from one or other of the two sampling processing techniques and perioperative management of samples : the Ultra Turrax method that uses grinding versus the standard method.

The secondary objectives of this study are to: A. Compare the two techniques in terms of bacterial species identified. B. Compare the diagnostic capabilities (sensitivity and specificity) of the two sample processing techniques depending on the type of analyzed samples (soft tissue, bone tissue) (subgroup analysis). C. Compare the diagnostic capabilities (sensitivity and specificity) of the two sample processing techniques depending on the type of joint (subgroup analysis). D. Compare the diagnostic capabilities (sensitivity and specificity) of the two sample processing techniques depending on the type of implanted materials (prosthesis versus other equipment) (subgroup analysis). E. Develop a culture collection of bacteria isolated from infection osteo-articular protheses.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

122

Conditions

Bacterial Infection

Interventions

Biological sampling grindingBIOLOGICAL

One half of the biological material collected during the intervetion (according to standard procedures) will be ground using the Ultra Turrax technique before proceeding with culturing.

Biological sampling with standard proceduresBIOLOGICAL

One half of the biological material collected during the intervetion (according to standard procedures) will be treated according to standard techniques before proceeding with culturing.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient must be insured or beneficiary of a health insurance plan * The patient is cared for in the operating theater because of a suspicion of an osteo-articular infection involving any type of material (protheses, screws, plates) and requiring bacteriological sampling * The patient has not taken any antibiotics within the past 15 days Exclusion Criteria: * The patient is participating in another study * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection * It is impossible to correctly inform the patient * The patient is pregnant, parturient, or breastfeeding * The subject presents with an osteo-articulaire infection without material * Systematic samplings from reversals of aseptic prostheses * Second intervention for the same patient

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France

Outcomes

Primary Outcomes

Presence/absence of an osteo-articular infection according to sample that underwent Ultra Turrax® grinding

Time frame: Baseline

Presence/absence of an osteo-articular infection according to sample that underwent standard treatment

Time frame: Baseline

Secondary Outcomes

Identification of bacterial species

Time frame: Baseline

Data from ClinicalTrials.gov

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