Open Heart SurgeryNCT05715060
Sternal Closure in Children After Cardiac Surgery
A study testing Median sternotomy closure (sternal closure) in people with Open Heart Surgery, run by Assiut University at 1 site in Egypt.
Trial summary
comparison between stainless steel wires and PDS in closure of sternum in children after cardiac surgery in terms of sternal dehiscence, infection \& cosmetic outcome Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Open Heart Surgery
- What is being tested?
- Median sternotomy closure (sternal closure)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2023to Dec 2024
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants \& children up to 5 years old underwent open heart surgery in Assiut University heart hospital
Who cannot join
- Older than 5 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stainless Steel Wire vs. Polydioxanone "PDS" at Sternal Closure in Children After Cardiac Surgery
comparison between stainless steel wires and PDS in closure of sternum in children after cardiac surgery in terms of sternal dehiscence, infection \& cosmetic outcome
Read the detailed description
Median sternotomy is considered to be the gold standard incision in cardiac surgery. Sternotomy has to be performed properly to avoid short- and long-term morbidity and mortality. The surgical technique is well established and certain principles are recognized to be crucial to minimize complications. The identification of the correct landmarks, midline tissue preparation, osteotomy with the avoidance of injury to underlying structures like pleura, pericardium and ectatic ascending aorta, and targeted bleeding control are important steps of the procedure. As important as the performance of a proper sternotomy is a correct sternal closure. An override or shift of the sternal edges has to be avoided by placing the wires at a proper distance from each other without injuring the thoracic pedicle. The two sternal halves have to be tightly re-approximated to facilitate healing of the bone and to avoid instability, which is a risk factor for wound infection. With a proper performance of sternotomy and sternal closure, instability and wound infections are rare and depend on patient-related risk factors . Conventional closure uses stainless steel wire sutures which may not be the ideal approach as sternal wound infection and mediastinitis are troublesome complications following this method which are major causes of morbidity and mortality of patients. Availability of delayed absorbable sutures such as polydioxanone sutures (PDS) for sternal closure allows us to test the efficacy of it in prevention of these complications.
- Conditions
- Open Heart Surgery
- Being tested
- Median sternotomy closure (sternal closure)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Median sternotomy closure (sternal closure)Procedure or surgery
Comparison of Sternal closure after cardiac surgery between conventional way which is by stainless steel wire \& Polydioxanone (PDS)
| Study group | Role | What they receive |
|---|---|---|
| stainless steel wire closure | Active comparator | conventional closure of median sternotomy by stainless steel wire Receives: Procedure: Median sternotomy closure (sternal closure) |
| PDS sternal closure | Active comparator | closure of median sternotomy by PDS Receives: Procedure: Median sternotomy closure (sternal closure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sternal stability
Comparison of incidence of sternal dehiscence \& instability between 2 groups this is done by clinical assessment(history \& examination) \& follow up chest x-rays
Measured: up to 2 years
Secondary outcomes (2)
cosmetic outcome (prominent wire)
calculation and observation of prominent wire incidence in patients closed with stainless steel wire Done by clinical assessment(history \& examination)
Measured: up to 2 years
Wound infection
comparison of incidence of skin infection between 2 groups Done by clinical assessment(history \& examination)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study startMar 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Heart SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Ibrahim Mohammad AbdelHafeez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715060
- Sponsor's protocol ID
- sternal closure in children
- Status last verified
- Feb 2023
- First submitted
- 8 Nov 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stainless Steel Wire vs. Polydioxanone "PDS" at Sternal Closure in Children After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05715060
- Acronym / sponsor ID
- sternal closure in children
- Conditions
- Open Heart Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Feb 2023 (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.
comparison between stainless steel wires and PDS in closure of sternum in children after cardiac surgery in terms of sternal dehiscence, infection \& cosmetic outcome
Detailed description
Median sternotomy is considered to be the gold standard incision in cardiac surgery. Sternotomy has to be performed properly to avoid short- and long-term morbidity and mortality. The surgical technique is well established and certain principles are recognized to be crucial to minimize complications. The identification of the correct landmarks, midline tissue preparation, osteotomy with the avoidance of injury to underlying structures like pleura, pericardium and ectatic ascending aorta, and targeted bleeding control are important steps of the procedure. As important as the performance of a proper sternotomy is a correct sternal closure. An override or shift of the sternal edges has to be avoided by placing the wires at a proper distance from each other without injuring the thoracic pedicle. The two sternal halves have to be tightly re-approximated to facilitate healing of the bone and to avoid instability, which is a risk factor for wound infection. With a proper performance of sternotomy and sternal closure, instability and wound infections are rare and depend on patient-related risk factors . Conventional closure uses stainless steel wire sutures which may not be the ideal approach as sternal wound infection and mediastinitis are troublesome complications following this method which are major causes of morbidity and mortality of patients. Availability of delayed absorbable sutures such as polydioxanone sutures (PDS) for sternal closure allows us to test the efficacy of it in prevention of these complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stainless steel wire closure | Active comparator | Procedure: Median sternotomy closure (sternal closure)conventional closure of median sternotomy by stainless steel wire |
| PDS sternal closure | Active comparator | Procedure: Median sternotomy closure (sternal closure)closure of median sternotomy by PDS |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants \& children up to 5 years old underwent open heart surgery in Assiut University heart hospital
Key exclusion criteria (1 listed)
- Older than 5 years old
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 |
|---|---|---|
| Median sternotomy closure (sternal closure)Comparison of Sternal closure after cardiac surgery between conventional way which is by stainless steel wire \& Polydioxanone (PDS) | Procedure or surgery | PDS sternal closure, stainless steel wire closure |
Primary outcome
Sternal stability
Time frame: up to 2 years
Comparison of incidence of sternal dehiscence \& instability between 2 groups this is done by clinical assessment(history \& examination) \& follow up chest x-rays
2 secondary outcomes
cosmetic outcome (prominent wire)
Time frame: up to 2 years
Wound infection
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Median sternotomy closure (sternal closure) in people with Open Heart Surgery, 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 1 inclusion and 1 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 6 Feb 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sternal stability (time frame: up to 2 years). 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 6 Feb 2023.