Orthopedic SurgeryNCT05181163
Biofilm Formation and Antibiotic Sensitivity Patterns
An observational study of Orthopedic Surgery, run by Sohag University.
Trial summary
Detection of bacteria that form biofilm and its sensitivity to antibiotics in patients with surgical site infection after orthopedic surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthopedic Surgery
- What is being tested?
- swab
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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 ,…)
Who may be able to join
- patients with surgical site infection after orthopedic surgery that include insertion of implant (e.g plates , screws ,wires ,…)
Who cannot join
- if patient has no orthopedic surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: In Vitro Biofilm Formation and Antibiotic Susceptibility Patterns of Bacteria From Surgical Site Infection After Orthopedic Surgery
Detection of bacteria that form biofilm and its sensitivity to antibiotics in patients with surgical site infection after orthopedic surgery.
Read the detailed 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.
- Conditions
- Orthopedic Surgery
- Being tested
- swab
- Keywords
- biofilm antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
swabDiagnostic test
Swabs from site of infection will be taken
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Ahmed Talaat, Sohag University
- Investigators
- principal investigator, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181163
- Sponsor's protocol ID
- Soh-Med-21-11-03
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Biofilm Formation and Antibiotic Susceptibility Patterns of Bacteria From Surgical Site Infection After Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT05181163
- Acronym / sponsor ID
- Soh-Med-21-11-03
- Conditions
- Orthopedic Surgery
- Keywords
- biofilm antibiotics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Detection of bacteria that form biofilm and its sensitivity to antibiotics in patients with surgical site infection after orthopedic surgery.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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 ,…)
Key inclusion criteria (1 listed)
- patients with surgical site infection after orthopedic surgery that include insertion of implant (e.g plates , screws ,wires ,…)
Key exclusion criteria (1 listed)
- if patient has no orthopedic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| swabSwabs from site of infection will be taken | Diagnostic test | – |
Primary outcome
detect biofilm formation
Time frame: one year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
principal investigator principal investigator
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Surgery, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact principal investigator (01017633218, amiratalaat29@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detect biofilm formation (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.