Back to resultsGrinding Versus Standard Methods for the Treatment of Per-operative Bacteriological Samples Associated With Osteo-articular Sepsis (IOAP Turrax)
Primary Purpose
Bacterial Infection
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological sampling grinding
Biological sampling with standard procedures
Sponsored by
About this trial
This is an interventional diagnostic trial for Bacterial Infection focused on measuring Protheses, nails, screws or plates
Eligibility Criteria
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
Sites / Locations
- CHRU de Nîmes - Hôpital Universitaire Carémeau
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Per-op biopsy around material
Arm 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
Outcomes
Primary Outcome Measures
Presence/absence of an osteo-articular infection according to sample that underwent Ultra Turrax® grinding
Presence/absence of an osteo-articular infection according to sample that underwent standard treatment
Secondary Outcome Measures
Identification of bacterial species
Full Information
NCT ID
NCT02598141
First Posted
November 4, 2015
Last Updated
August 3, 2020
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT02598141
Brief Title
Grinding Versus Standard Methods for the Treatment of Per-operative Bacteriological Samples Associated With Osteo-articular Sepsis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 18, 2016 (Actual)
Primary Completion Date
November 21, 2018 (Actual)
Study Completion Date
November 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infection
Keywords
Protheses, nails, screws or plates
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Per-op biopsy around material
Arm Type
Other
Arm 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
Intervention Type
Biological
Intervention Name(s)
Biological sampling grinding
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Biological sampling with standard procedures
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence/absence of an osteo-articular infection according to sample that underwent Ultra Turrax® grinding
Time Frame
Baseline
Title
Presence/absence of an osteo-articular infection according to sample that underwent standard treatment
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Identification of bacterial species
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Cellier, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
Learn more about this trial
Grinding Versus Standard Methods for the Treatment of Per-operative Bacteriological Samples Associated With Osteo-articular Sepsis
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