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NCT05181163 Clinical Trial

Biofilm Formation and Antibiotic Sensitivity Patterns

Orthopedic Surgery Clinical Trial

Official title:
In Vitro Biofilm Formation and Antibiotic Susceptibility Patterns of Bacteria From Surgical Site Infection After Orthopedic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05181163
Other study ID # Soh-Med-21-11-03
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2022
Est. completion date January 2023

Study information
Verified date December 2021
Source Sohag University
Contact principal investigator
Phone 01017633218
Email amiratalaat29@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Detection of bacteria that form biofilm and its sensitivity to antibiotics in patients with surgical site infection after orthopedic surgery.

Description:

The available number of patients presenting in outpatient clinic or at operating theatre with surgical site infection after orthopedic surgery that include insertion of implant (e.g plates , screws ,wires ,…) will be subjected to full history and examined by physician. Swabs from site of infection will be taken and subjected to the following steps to identify the causative bacteria: - Culturing on blood agar, chocolate agar, MacConkey agar and Mannitol salt agar , gram staining and biochemical tests. - Enzyme-linked immunosorbent assay (ELISA) to detect biofilm formation. - Antimicrobial Susceptibility Testing using the Kirby-Bauer disk diffusion method.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date January 2023
Est. primary completion date July 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients with surgical site infection after orthopedic surgery that include insertion of implant (e.g plates , screws ,wires ,…) Exclusion Criteria: - if patient has no orthopedic surgery

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• swab
Swabs from site of infection will be taken

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sohag University

Outcome
Type Measure Description Time frame Safety issue
Primary detect biofilm formation The available number of patients presenting in outpatient clinic or at operating theatre with surgical site infection after orthopedic surgery that include insertion of implant (e.g plates , screws ,wires ,…) will be subjected to full history and examined by physician. Swabs from site of infection will be taken and subjected to Enzyme-linked immunosorbent assay (ELISA) to detect biofilm formation. one year
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