Sternal Wound Infection in Patients Undergone Sternal Fix... | NCT05040399

Studies
Sternal Wound Infection in Patients Undergone Sternal Fixation Using Locking Compression Plates

NCT05040399

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Sep 10, 2021Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Sternal Fracture
Sternal Wound Infection
Surgical Site Infection

Interventions

Locking Compression Plates
Sternal Wires

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

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2019Actual

Primary Completion Date

Mar 1, 2022Estimated

Completion Date

Mar 1, 2022Estimated

First Submitted Date

Aug 21, 2021

First Submission Date that Met QC Criteria

Sep 7, 2021

First Posted Date

Sep 10, 2021Actual

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

Sep 7, 2021

Last Update Posted Date

Sep 10, 2021Actual

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

Sternal Wound Infection (SWI) in open heart surgery is one of the most annoying and avoidable complications that one encounters during work. Investigators investigate the rates of sternal wound infection (SWI) in patients in whom were used locking compression plates (LCP) versus in patients in whom were used wires to fixate the sternum for variable causes. SWI increases the overall cost and burden in the medical service and increases the patients suffering and disability. investigators aim to provide our patients with the most suitable means for sternal fixation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Locking Compression Plates	Other	Patients in whom we used Locking compression plates for sternal fixation	Other: Locking Compression Plates
Wires	Other	Patients in whom we used Sternal Wires for sternal fixation	Other: Sternal Wires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Locking Compression Plates	Other	Plates and screws for sternal fixation	Locking Compression Plates

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sternal Wound Infection rate	sternal wound infection in the form of redness, hotness, swelling and discharge	3 weeks post-operative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All genders are accepted
Ages from 18 to 80 years old
Patients undergoing Open heart surgery for any reasons and trauma patients who suffer sternal fractures of any type.

Exclusion Criteria:

Ages less than 18 years old and older than 80 years old
Patients undergoing minimally invasive surgeries utilizing access sites other than the sternum.
Trauma patients with multiple complex injuries.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty Of Medicine	Recruiting	Asyut		21557	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection
D014946	Wound Infection

Ancestor Terms

ID	Term
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided