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

NCT ID: NCT05040399

Last Updated: 2021-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-20

Study Completion Date

2022-03-01

Brief Summary

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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

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Conditions

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Sternal Fracture Sternal Wound Infection Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Case-Control
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Locking Compression Plates

Patients in whom we used Locking compression plates for sternal fixation

Group Type OTHER

Locking Compression Plates

Intervention Type OTHER

Plates and screws for sternal fixation

Wires

Patients in whom we used Sternal Wires for sternal fixation

Group Type OTHER

Sternal Wires

Intervention Type OTHER

sternal wires used for fixation of sternum

Interventions

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Locking Compression Plates

Plates and screws for sternal fixation

Intervention Type OTHER

Sternal Wires

sternal wires used for fixation of sternum

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Kareem Ahmed Hosny

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty Of Medicine

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Kareem Ahmed Hosny

Role: primary

01000401994

Other Identifiers

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AssiutUnivMed

Identifier Type: -

Identifier Source: org_study_id

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