Biofilm Formation and Antibiotic Sensitivity Patterns | NCT05181163

Studies
Biofilm Formation and Antibiotic Sensitivity Patterns

NCT05181163

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Jan 6, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Orthopedic Surgery

Interventions

swab

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2022Estimated

Primary Completion Date

Jul 2022Estimated

Completion Date

Jan 2023Estimated

First Submitted Date

Dec 8, 2021

First Submission Date that Met QC Criteria

Dec 19, 2021

First Posted Date

Jan 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2021

Last Update Posted Date

Jan 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
swab	Diagnostic Test	Swabs from site of infection will be taken

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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 ,…)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
principal investigator	Contact	01017633218		amiratalaat29@gmail.com

Overall Officials

Name	Affiliation	Role
principal investigator	Sohag University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Feb 4, 2024
Reset	Jul 19, 2024

Submission Tracking

Estimated Results First Submitted Date

Feb 4, 2024

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 4, 2024			Jul 19, 2024