Sternal Closure in Children After Cardiac Surgery

NCT ID: NCT05715060

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2024-12-31

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.

Conditions

Open Heart Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

stainless steel wire closure

conventional closure of median sternotomy by stainless steel wire

Group Type: ACTIVE_COMPARATOR

Median sternotomy closure (sternal closure)

Intervention Type: PROCEDURE

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

PDS sternal closure

closure of median sternotomy by PDS

Group Type: ACTIVE_COMPARATOR

Median sternotomy closure (sternal closure)

Intervention Type: PROCEDURE

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

Interventions

Median sternotomy closure (sternal closure)

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Ibrahim Mohammad AbdelHafeez

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University heart hospital

Asyut, , Egypt

Countries

Egypt

Other Identifiers

sternal closure in children

Identifier Type: -

Identifier Source: org_study_id