Back to resultsSternal Wound Infection in Patients Undergone Sternal Fixation Using Locking Compression Plates
Primary Purpose
Sternal Fracture, Sternal Wound Infection, Surgical Site Infection
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Locking Compression Plates
Sternal Wires
Sponsored by
About this trial
This is an interventional treatment trial for Sternal Fracture focused on measuring sternum, wound infection, locking compression plates, sternal wires
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.
Sites / Locations
- Faculty Of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Locking Compression Plates
Wires
Arm Description
Patients in whom we used Locking compression plates for sternal fixation
Patients in whom we used Sternal Wires for sternal fixation
Outcomes
Primary Outcome Measures
Sternal Wound Infection rate
sternal wound infection in the form of redness, hotness, swelling and discharge
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05040399
Brief Title
Sternal Wound Infection in Patients Undergone Sternal Fixation Using Locking Compression Plates
Official Title
Sternal Wound Infection in Patients Undergone Sternal Fixation Using Locking Compression Plates
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2019 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sternal Fracture, Sternal Wound Infection, Surgical Site Infection
Keywords
sternum, wound infection, locking compression plates, sternal wires
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Case-Control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Locking Compression Plates
Arm Type
Other
Arm Description
Patients in whom we used Locking compression plates for sternal fixation
Arm Title
Wires
Arm Type
Other
Arm Description
Patients in whom we used Sternal Wires for sternal fixation
Intervention Type
Other
Intervention Name(s)
Locking Compression Plates
Intervention Description
Plates and screws for sternal fixation
Intervention Type
Other
Intervention Name(s)
Sternal Wires
Intervention Description
sternal wires used for fixation of sternum
Primary Outcome Measure Information:
Title
Sternal Wound Infection rate
Description
sternal wound infection in the form of redness, hotness, swelling and discharge
Time Frame
3 weeks post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Faculty Of Medicine
City
Assiut
ZIP/Postal Code
21557
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kareem Ahmed Hosny
Phone
01000401994
Email
kareemdna94@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Sternal Wound Infection in Patients Undergone Sternal Fixation Using Locking Compression Plates
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