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

NCT05040399 | Unknown DMC

• 1 other identifier: AssiutUnivMed
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Sternal Fracture; Sternal Wound Infection; Surgical Site Infection

Keywords

sternum; wound infection; locking compression plates; sternal wires

Outcome Measures

Primary Outcomes (1)

• Sternal Wound Infection rate

  sternal wound infection in the form of redness, hotness, swelling and discharge

  3 weeks post-operative

Study Arms (2)

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

Locking Compression Plates OTHER

Plates and screws for sternal fixation

Locking Compression Plates

Sternal Wires OTHER

sternal wires used for fixation of sternum

Wires

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty Of Medicine

Asyut, 21557, Egypt

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection; Wound Infection

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Case-Control

Study Record Dates

• First Submitted: August 21, 2021
• First Posted: September 10, 2021
• Study Start: April 20, 2019
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)