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Sternal Closure in Children After Cardiac Surgery

Stainless Steel Wire vs. Polydioxanone PDS at Sternal Closure in Children After Cardiac Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05715060
Enrollment
45
Registered
2023-02-06
Start date
2023-03-31
Completion date
2024-12-31
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Heart Surgery

Brief 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

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.

Interventions

PROCEDUREMedian sternotomy closure (sternal closure)

Comparison of Sternal closure after cardiac surgery between conventional way which is by stainless steel wire & Polydioxanone (PDS)

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No

Inclusion criteria

* Infants & children up to 5 years old underwent open heart surgery in Assiut University heart hospital

Exclusion criteria

* Older than 5 years old

Design outcomes

Primary

MeasureTime frameDescription
Sternal stabilityup to 2 yearsComparison of incidence of sternal dehiscence & instability between 2 groups this is done by clinical assessment(history & examination) & follow up chest x-rays

Secondary

MeasureTime frameDescription
cosmetic outcome (prominent wire)up to 2 yearscalculation and observation of prominent wire incidence in patients closed with stainless steel wire Done by clinical assessment(history & examination)
Wound infectionup to 2 yearscomparison of incidence of skin infection between 2 groups Done by clinical assessment(history & examination)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026