Recruiting

Sternal Plate & Wire Cerclage

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT06660186

Conditions

Heart Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Rigid Sternal Fixation

Wire Cerclage

Study Details

Brief summary:

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.

Conditions

Heart Diseases

Study ID

NCT06660186

Start date

Mar 12, 2026

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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 your sternum together.

Primary outcome measure

  • Sternal healing as measured by CT scan [ Time Frame: 6 months ]
  • Number of sternal wound complications as measured by patient/physician report [ Time Frame: 6 months ]
  • Total index hospitalization cost [ Time Frame: 6 months ]
  • Total cost [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Stacey Mazzurco

216-844-3130Stacey.Mazzurco@UHhospitals.org

Locations

University Hospitals

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Stacey Mazzurco

216-844-3130Stacey.Mazzurco@UHhospitals.org

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • Cardiac Surgery
  • Wound Complication
  • Rigid Sternal Fixation
  • Sternal Infection
  • Pain
  • Non-union

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-04-30.