Sternal Plating High Risk

Marc Pelletier

Status: Begins enrollment in 1 month

Conditions: Heart Diseases

Treatments: Device: Rigid Sternal Fixation; Device: Wire Cerclage

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06660186

STUDY20240513

Details and patient eligibility

About

Participants are being invited to participate in a research study at University Hospitals because they have heart disease and are scheduled for open heart surgery. Currently, UH cardiac surgeons close the sternum (or breastbone) after a sternotomy (procedure that allows a doctor to reach the heart and blood vessels) with either a rigid plate fixation Sternal Plate or a Wire Cerclage. However, the study team would like to further evaluate these two techniques. Any volunteer over the age of 18 who is at an increased risk for developing sternal wound complications may be eligible to participate.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Preoperative Inclusion Criteria

• Adults (age range: 18-89)

• Undergoing cardiac surgery through sternotomy

  -≥2 risk factors:

• Diabetes mellitus

• Severe COPD

• Chronic steroid use

• Immunosuppression

• Redo sternotomy

• Chronic

• Kidney disease with GFR >30 ml/min per 1.73m2

• Radiation therapy

• BMI≥35

• High-risk of delirium

• Heavy alcohol use

Preoperative Exclusion Criteria

• Active malignancy
• Chronic narcotic use
• NYHA Class IV
• Known nickel metal allergy
• Compliance concern
• eGFR<30 ml/min per 1.73m2
• Involvement in another interventional clinical trial (non-registry)
• Any criteria precluding RPF or WC

Operative Inclusion Criteria

• Off-midline sternotomy
• BITA grafting
• CPB time ≥120 minutes
• Transverse sternal fracture

Operative Exclusion Criteria

• Emergent or emergent salvage surgery
• Non-standard sternotomies
• Sternotomy with bony margin <2 mm
• Bleeding
• Delayed sternal closure
• Surgical complications
• Any criteria precluding RPF or WC

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Rigid Sternal Fixation

Experimental group

Description:

The surgeon will close the sternum (breastbone) using the SternalPlate system. The SternalPlate System consists of implants and instruments used to hold the two halves of the sternum together.

Treatment:

Device: Rigid Sternal Fixation

Wire Cerclage

Active Comparator group

Description:

The surgeon will close the sternum (breastbone) using Wire Cerclage. Wire Cerclage consists of stainless steel wires used to hold the two halves of the sternum together.

Treatment:

Device: Wire Cerclage