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

Bacterial Infection Clinical Trial

— IOAP Turrax  

Official title:

Comparative Evaluation of Two Techniques for the Treatment of Per-operative Bacteriological Samples Associated With Osteo-articular Sepsis: Grinding (Ultra Turrax) Versus Standard Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598141
• Other study ID #: LOCAL/2015/NC-01
• Secondary ID: 2015-A00720-49
• Status: Completed
• Phase: N/A
• Start date: May 18, 2016
• Est. completion date: November 21, 2018

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: November 21, 2018
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections

Intervention

Biological:
• Biological sampling grinding
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 procedures
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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence/absence of an osteo-articular infection according to sample that underwent Ultra Turrax® grinding		Baseline
Primary	Presence/absence of an osteo-articular infection according to sample that underwent standard treatment		Baseline
Secondary	Identification of bacterial species		Baseline