Sternal Plating High Risk

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
University Hospitals Cleveland Medical Center
Study ID
NCT06660186
Status
Recruiting
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Conditions

  • Heart Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Rigid Sternal Fixation — DEVICE
    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.
  • Wire Cerclage — DEVICE
    The surgeon will close the sternum (breastbone) using Wire Cerclage. Wire Cerclage consists of stainless steel wires used to hold the two halves of your sternum together.

Study Details

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.

Key Dates

Start date
Mar 12, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rigid Sternal Fixation
    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.
  • Active Comparator: Wire Cerclage
    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.

Primary Outcome Measure

Sternal healing as measured by CT scan [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University HospitalsClevelandOhio44106
Stacey Mazzurco
[email protected]
216-844-3130

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By research site
University Hospitals· Cleveland, OH

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