Investigating the safety and efficacy of sternal closure with the Waston Sternal Claw Fixation System for Cardiothoracic Surgical Patients

Not Applicable

• Conditions: Cardiothoracic Surgery; Median Sternotomy; Surgery - Surgical techniques

• Registration Number: ACTRN12622001422718
• Lead Sponsor: Professor Jayme Bennetts

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-07
• Last Update Posted: 14 November 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patients who undergo median sternotomy for any cardiac procedure
-Patients aged 18-80
-Patients who have sufficient English language
-Patients able to and willing to comply with all study procedures
-Patient able to understand and provide informed consent

Exclusion Criteria

-Patients allergic to heavy alloy
-Patients undergoing re-do procedure
-Patients who have chronic steroid or narcotic use
-Patients with a clinical sternal deformity
-Pregnant women
-Patients with a body mass index greater than or equal to 40
-Patients with severe chronic obstructive airway disease
-Patients with dialysis dependent renal failure.
-Patients who have any of the following Sternal Claw contraindications:
oSevere mental disorder
oGeneralized nervous disease
oImmune suppression disorder
oCalcified tissue metabolism disorder
oSystematic or local infections
oAllergic to metal materials

Intra-Operative criteria
-Any intra-operative condition that would preclude the use of the Sternal Claw as deemed appropriate by the treating surgeon
opoor bone quality
oparamedian (non midline) sternotomy
obleeding (or high likelihood of depending on case specific issues)
oSizing/technical suitability for CLAW plating system or concerns around use of routine sternal wires
oOther surgical complications as assessed by operating surgeon

Study & Design

• Study Type: Interventional
• Study Design: Not specified