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

Not Applicable

Completed

• Conditions: Bacterial Infection
• Interventions: Biological: Biological sampling grinding; Biological: Biological sampling with standard procedures

• Registration Number: NCT02598141
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-05
• Study Start: 2016-05-18
• Primary Completion: 2018-11-21
• Study Completion: 2018-11-21
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Per-op biopsy around material	Biological sampling grinding	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
Per-op biopsy around material	Biological sampling with standard procedures	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

Primary Outcome Measures

Name	Time	Method
Presence/absence of an osteo-articular infection according to sample that underwent standard treatment	Baseline
Presence/absence of an osteo-articular infection according to sample that underwent Ultra Turrax® grinding	Baseline

Secondary Outcome Measures

Name	Time	Method
Identification of bacterial species	Baseline

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France