Sternal FractureNCT05040399
Sternal Wound Infection in Patients Undergone Sternal Fixation Using Locking Compression Plates
A study testing Locking Compression Plates and Sternal Wires in people with Sternal Fracture and Sternal Wound Infection, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sternal Fracture, Sternal Wound Infection, Surgical Site Infection
- What is being tested?
- Locking Compression Plates and Sternal Wires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2019to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty Of Medicine
Asyut, 21557
Kareem Ahmed Hosny, 01000401994, kareemdna94@gmail.com
About this study
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.
- Being tested
- Locking Compression Plates, Sternal Wires
- Keywords
- sternum, wound infection, locking compression plates, sternal wires
- Medical subject headings
- Surgical Wound Infection, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locking Compression PlatesOther
Plates and screws for sternal fixation
Sternal WiresOther
sternal wires used for fixation of sternum
| Study group | Role | What they receive |
|---|---|---|
| Locking Compression Plates | Other | Patients in whom we used Locking compression plates for sternal fixation Receives: Other: Locking Compression Plates |
| Wires | Other | Patients in whom we used Sternal Wires for sternal fixation Receives: Other: Sternal Wires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sternal Wound Infection rate
sternal wound infection in the form of redness, hotness, swelling and discharge
Measured: 3 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start20 Apr 2019
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sternal FractureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Case-Control
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Ahmed Hosny, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040399
- Sponsor's protocol ID
- AssiutUnivMed
- Status last verified
- Sep 2021
- First submitted
- 21 Aug 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sternal Wound Infection in Patients Undergone Sternal Fixation Using Locking Compression Plates
- ClinicalTrials.gov ID
- NCT05040399
- Acronym / sponsor ID
- AssiutUnivMed
- Keywords
- sternum, wound infection, locking compression plates, sternal wires
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Apr 2019 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case-Control
| Arm | Type | Receives |
|---|---|---|
| Locking Compression Plates | Other | Other: Locking Compression PlatesPatients in whom we used Locking compression plates for sternal fixation |
| Wires | Other | Other: Sternal WiresPatients in whom we used Sternal Wires for sternal fixation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locking Compression PlatesPlates and screws for sternal fixation | Other | Locking Compression Plates |
| Sternal Wiressternal wires used for fixation of sternum | Other | Wires |
Primary outcome
Sternal Wound Infection rate
Time frame: 3 weeks post-operative
sternal wound infection in the form of redness, hotness, swelling and discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locking Compression Plates and Sternal Wires in people with Sternal Fracture and Sternal Wound Infection, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sternal Wound Infection rate (time frame: 3 weeks post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.