CClinicalTrials.gg
Status unknownNCT05040399Updated Sep 10, 2021

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

An interventional study of Locking Compression Plates and Sternal Wires in Sternal Fracture, Sternal Wound Infection and Surgical Site Infection, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-10.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Apr 2019, registered Aug 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sternal Fracture
  • Sternal Wound Infection
  • Surgical Site Infection

Keywords

  • sternum
  • wound infection
  • locking compression plates
  • sternal wires
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 10 is below the median of 120 across 4,200 interventional studies indexed under Infections.

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Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Other
    Locking Compression Plates

    Patients in whom we used Locking compression plates for sternal fixation

    Other: Locking Compression Plates

  • Other
    Wires

    Patients in whom we used Sternal Wires for sternal fixation

    Other: Sternal Wires

Interventions

  • OtherLocking Compression Plates

    Plates and screws for sternal fixation

  • OtherSternal Wires

    sternal wires used for fixation of sternum

06

What researchers measure

Primary outcomes

  1. Sternal Wound Infection rate

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

    Time frame: 3 weeks post-operative

07

Study locations

1 of 1 sites recruiting
  • Faculty Of Medicine
    Assiut, 21557, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05040399
Lead sponsor
Assiut University
Responsible party
Kareem Ahmed Hosny (Principle investigator, Assiut University) — Principal investigator
First posted
Sep 10, 2021
Start date
Apr 20, 2019
Primary completion
Mar 1, 2022 (estimated)
Completion
Mar 1, 2022 (estimated)
Last update
Sep 10, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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