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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Bacterial Infection

Treatments: Biological: Biological sampling with standard procedures; Biological: Biological sampling grinding

Study type: Interventional

Funder types: Other

Identifiers

NCT02598141

2015-A00720-49 (Other Identifier)

LOCAL/2015/NC-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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122 participants in 1 patient group

Per-op biopsy around material

Other group

Description:

Patients included in this study require biopsies for suspicion of infected osteo-articular materials (implants, protheses, nails, screw, plates). Interventions: * Biological sampling grinding * Biological sampling with standard procedures

Treatment:

Biological: Biological sampling with standard procedures

Biological: Biological sampling grinding