NCT05181163

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

January 6, 2022

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

December 8, 2021

Last Update Submit

December 19, 2021

Conditions

Orthopedic Surgery

Keywords

biofilm antibiotics

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

swabDIAGNOSTIC_TEST

Swabs from site of infection will be taken

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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 ,…)

You may qualify if:

  • patients with surgical site infection after orthopedic surgery that include insertion of implant (e.g plates , screws ,wires ,…)

You may not qualify if:

  • if patient has no orthopedic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • principal investigator

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

principal investigator

CONTACT

01017633218amiratalaat29@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 8, 2021

First Posted

January 6, 2022

Study Start

January 1, 2022

Primary Completion

July 1, 2022

Study Completion

January 1, 2023

Last Updated

January 6, 2022

Record last verified: 2021-12