Sternal Closure in Children After Cardiac Surgery

Open Heart Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05715060
• Other study ID #: sternal closure in children
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Open Heart Surgery

Intervention

Procedure:
• Median sternotomy closure (sternal closure)
Comparison of Sternal closure after cardiac surgery between conventional way which is by stainless steel wire & Polydioxanone (PDS)

Locations

Country	Name	City	State
Egypt	Assiut University heart hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 2 years
Secondary	cosmetic outcome (prominent wire)	calculation and observation of prominent wire incidence in patients closed with stainless steel wire Done by clinical assessment(history & examination)	up to 2 years
Secondary	Wound infection	comparison of incidence of skin infection between 2 groups Done by clinical assessment(history & examination)	up to 2 years