Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06267287
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2024-01-24
Brief Title:
Microbiological Structure of Pathogens of Periprosthetic Infection of Large Joints in the Post-Covid Period
Sponsor:
Federal State Budgetary Organization Federal Center for Traumatology Orthopedics and Arthroplasty
Organization:
Federal State Budgetary Organization Federal Center for Traumatology Orthopedics and Arthroplasty
Study Overview
Official Title:
Microbiological Structure of Pathogens of Periprosthetic Infection of Large Joints in the Post-Covid Period
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Infection is the most common complication of complications after joint arthroplasty During the COVID-19 pandemic increased used antibacterial drugs by adults this could change the spectrum of infectious agents and their antimicrobial resistance The purpose of the study is to evaluate the microbial diversity of pathogens of periprosthetic infection in the pre- and post-Covid period determining the sensitivity of the leading pathogens to antibiotics Materials and methods A comprehensive comparative retrospective study was carried out on 342 cases of monomicrobial and polymicrobial periprosthetic infection PPI of limb joints with microbiological growth of microorganisms in the pre-Covid 2018-2019 and post-Covid 2021-2022 periods
Detailed Description:
A continuous comparative retrospective study of cases of PJI of the joints of the extremities with positive microbiological growth of microorganisms in the pre-Covid 2018-2019 and post-Covid 2021-2022 periods was carried out on the data basis from the medical information system MIS of the Federal Center for Traumatology Orthopedics and Arthroplasty of Ministry of Health of Russia Cheboksary Russia hereinafter referred to as the Center
Verification of the diagnosis of deep PJI was carried out according to the diagnostic criteria of the Society for Musculoskeletal Infections
The sample included cases of deep and superficial infection after arthroplasty of the knee hip shoulder and wrist joints regardless of the location of the primary operation Isolated microorganisms were identified based on growth in one or more cultures obtained from punctate synovial fluid intraoperative tissues and from removed implants after their ultrasonic treatment
The infection was classified as polymicrobial or monomicrobial The role of the leading pathogen was determined in the structure of monomicrobial infection Polymicrobial infection is represented by cases of simultaneous isolation of two or more pathogens in one patient The antibiotic resistance profile included all isolated pathogens of mono- and polymicrobial PJI
At least 4 samples of intraoperative material tissue biopsies joint aspirate removed endoprosthesis components were taken from patients for examination
The aspirate from the joint was placed into FA plus FN plus bottles of the BactAlert 3D analyzer Bio Merieux France If the sample volume was insufficient less than 1 ml it was inoculated into a vial with Schedlers broth and when turbid subcultured onto solid media
The endoprosthesis components removed during surgery were placed in a sterile plastic container and delivered to the laboratory In the laboratory saline solution was added to the container and processed in an ultrasonic machine according to the authors method After ultrasonication 05 ml of the resulting liquid was applied to solid media
Homogenized tissue samples were placed in broth with thioglycollate medium The cultures were incubated at 37C for up to 14 days subcultured on solid nutrient media on the 1st day - on Columbia Chocolate and Schedler agars on the 5th day - on Chocolate and Schedler agar and on the 10th day - only on Schedler agar For aerobic anaerobic and capnophilic microorganisms incubation conditions were created using gas-generating packages
Identification of isolated microorganisms and sensitivity to antibiotics was carried out using an automatic analyzer Vitec2 compact Bio Merieux France and a semi-automatic analyzer Multiscan FC Thermo Fisher USA using kits Erba Lachema Czech Republic test systems Diagnostic systems Russia
Sensitivity to antibacterial drugs was tested using the disk diffusion method and analyzer kits Antibiotic sensitivity assessment was carried out in accordance with the criteria of EUCAST 2018 studies in 2018-2019 EUCAST 2021 studies in 2021-2022
Verification of the diagnosis of deep PJI was carried out according to the diagnostic criteria of the Society for Musculoskeletal Infections
The sample included cases of deep and superficial infection after arthroplasty of the knee hip shoulder and wrist joints regardless of the location of the primary operation Isolated microorganisms were identified based on growth in one or more cultures obtained from punctate synovial fluid intraoperative tissues and from removed implants after their ultrasonic treatment
The infection was classified as polymicrobial or monomicrobial The role of the leading pathogen was determined in the structure of monomicrobial infection Polymicrobial infection is represented by cases of simultaneous isolation of two or more pathogens in one patient The antibiotic resistance profile included all isolated pathogens of mono- and polymicrobial PJI
At least 4 samples of intraoperative material tissue biopsies joint aspirate removed endoprosthesis components were taken from patients for examination
The aspirate from the joint was placed into FA plus FN plus bottles of the BactAlert 3D analyzer Bio Merieux France If the sample volume was insufficient less than 1 ml it was inoculated into a vial with Schedlers broth and when turbid subcultured onto solid media
The endoprosthesis components removed during surgery were placed in a sterile plastic container and delivered to the laboratory In the laboratory saline solution was added to the container and processed in an ultrasonic machine according to the authors method After ultrasonication 05 ml of the resulting liquid was applied to solid media
Homogenized tissue samples were placed in broth with thioglycollate medium The cultures were incubated at 37C for up to 14 days subcultured on solid nutrient media on the 1st day - on Columbia Chocolate and Schedler agars on the 5th day - on Chocolate and Schedler agar and on the 10th day - only on Schedler agar For aerobic anaerobic and capnophilic microorganisms incubation conditions were created using gas-generating packages
Identification of isolated microorganisms and sensitivity to antibiotics was carried out using an automatic analyzer Vitec2 compact Bio Merieux France and a semi-automatic analyzer Multiscan FC Thermo Fisher USA using kits Erba Lachema Czech Republic test systems Diagnostic systems Russia
Sensitivity to antibacterial drugs was tested using the disk diffusion method and analyzer kits Antibiotic sensitivity assessment was carried out in accordance with the criteria of EUCAST 2018 studies in 2018-2019 EUCAST 2021 studies in 2021-2022
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None