Sternal Closure in Children After Cardiac Surgery

Assiut University

Status: Not yet enrolling

Conditions: Open Heart Surgery

Treatments: Procedure: Median sternotomy closure (sternal closure)

Study type: Interventional

Funder types: Other

Identifiers

NCT05715060

sternal closure in children

Details and patient eligibility

About

comparison between stainless steel wires and PDS in closure of sternum in children after cardiac surgery in terms of sternal dehiscence, infection & cosmetic outcome

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

stainless steel wire closure

Active Comparator group

Description:

conventional closure of median sternotomy by stainless steel wire

Treatment:

Procedure: Median sternotomy closure (sternal closure)

PDS sternal closure

Active Comparator group

Description:

closure of median sternotomy by PDS

Treatment:

Procedure: Median sternotomy closure (sternal closure)