Sternal Closure in Children After Cardiac Surgery

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

Study Overview

• Status: Not yet recruiting
• Conditions: Open Heart Surgery
• Intervention / Treatment: Procedure: Median sternotomy closure (sternal closure)

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71511
    • Assiut University Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: stainless steel wire closure; conventional closure of median sternotomy by stainless steel wire	Procedure: Median sternotomy closure (sternal closure); Comparison of Sternal closure after cardiac surgery between conventional way which is by stainless steel wire & Polydioxanone (PDS)
ACTIVE_COMPARATOR: PDS sternal closure; closure of median sternotomy by PDS	Procedure: Median sternotomy closure (sternal closure); Comparison of Sternal closure after cardiac surgery between conventional way which is by stainless steel wire & Polydioxanone (PDS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Wound infection	comparison of incidence of skin infection between 2 groups Done by clinical assessment(history & examination)	up to 2 years

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2023
• Primary Completion (ANTICIPATED): June 1, 2024
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: February 4, 2023
• First Posted (ACTUAL): February 6, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 4, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: sternal closure in children

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No