Egyptian Arthroplasty Surgeons' Antibiotics Usage Awareness | NCT06451224

Studies
Egyptian Arthroplasty Surgeons' Antibiotics Usage Awareness

NCT06451224

Sponsor

South Valley University

Status

Completed

Last Update Posted

Oct 16, 2024Actual

Enrollment

105Actual

Phase

Not provided

Conditions

Infections Joint Prosthetic

Interventions

Questionnaire

Countries

Egypt

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2024Actual

Primary Completion Date

Aug 30, 2024Actual

Completion Date

Sep 30, 2024Actual

First Submitted Date

May 23, 2024

First Submission Date that Met QC Criteria

Jun 9, 2024

First Posted Date

Jun 11, 2024Actual

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

Oct 13, 2024

Last Update Posted Date

Oct 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed A. Khalifa, MD, FRCS, MSc, Assistant Professor, South Valley UniversityPrincipal Investigator

Lead Sponsor

South Valley UniversityOTHER

Collaborators

Name	Class
Assiut University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Total hip arthroplasty (THA) and total knee arthroplasty (TKA) are procedures successfully applied to manage various end-stage chronic hip and knee diseases, such as osteoarthritis, rheumatoid arthritis, and femoral head avascular necrosis, as well as acute conditions, such as the neck of femur fractures, with excellent long-term functional outcomes. One of the devastating complications after such a procedure is periprosthetic joint infection (PJI). Various precautions are proposed to guard against such complications; one is the administration of perioperative antibiotics. However, injudicious or misuse of antibiotics could lead to the emergence of antimicrobial resistance, further complicating this matter. This is why various scientific and research organizations have proposed guidelines and a consensus for proper antibiotic use in perioperative THA and TKA surgery.

Antibiotic prophylaxis during primary THA and TKA can reduce the risk of PJI and surgical site infections. However, there is a lack of consensus on the optimal dosages and duration of prophylaxis, and guidelines vary among institutions. Alternatives such as extended oral antibiotic prophylaxis and different antibiotic regimens are being explored. International research is needed to establish best practices and determine the potential risks of antibiotic prophylaxis during primary THA and TKA. Unfortunately, the investigators are unaware of such guidelines proposed by any Egyptian health authority to guide and control the proper utilization of antibiotics during orthoapedic practice in general and joint replacement surgeries (THA and TKA) in particular.

Detailed Description

This study will be an Online-based questionnaire investigating surgeons' perspectives on antibiotics utilization during primary total hip and knee arthroplasty surgeries and investigate their thoughts about the necessity for developing local guidelines.

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

105Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	Online Questionnaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the type of antibiotics administration during primary total hip and knee arthroplasty	The type of antibiotics will be determined as follows: the name of the antibiotic (brand or generic), and if single or dual antibiotics are used. These will be presented as numbers and percentages.	2 months

Secondary Outcomes

Measure	Description	Time Frame
To determine the dose of antibiotics administered during primary total hip and knee arthroplasty	The dose of antibiotics will be determined as grams or milligrams. Furthermore, the number of doses will be reported	2 months
To determine the timing of antibiotics administration during primary total hip and knee arthroplasty

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

All Egyptian registered members of the Egyptian Pelvis and Hip Society, practicing Egyptian joint replacement surgeons (performing surgeries as a leading surgeon) who are willing to participate

Exclusion criteria:

Members not listed in the E-mail directory of the society
Surgeons refusing to participate
Young surgeons who are not practicing independently

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Active practicing Egyptian joint replacement surgeons

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Abd El-Aal, MD	Assiut University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assuit Faculty of Medicine		Asyut	Asyut Governorate		Egypt

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

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

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Browse Branches

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