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Recruiting NCT06660186

Sternal Plating High Risk

No phase Interventional Heart Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rigid Sternal Fixation, Wire Cerclage.
Who it may be relevant to
Registry conditions: Heart Diseases. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Trial of Rigid Plate Fixation Versus Wire Cerclage in High-Risk Sternotomy Patients

Overview

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.

Interventions

  • Device 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.
  • Device 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 measures

  • 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]
Secondary outcome measures (5)
  • Change in pain as measured by the Wong-Baker pain scale [Time frame: Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months]
  • Change in prescribed narcotic use as measured by patient report [Time frame: Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months]
  • Change in upper extremity functional index (UEFI) [Time frame: Discharge (up to 10 days), 1 month, 6 months]
  • Change in quality of life as measured by the EuroQol EQ-5D-5L [Time frame: Discharge (up to 10 days), 1 month, 6 months]
  • Number of adverse events as measured by patient report [Time frame: Up to 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University Hospitals — Cleveland

Identifiers

NCT: NCT06660186 · STUDY20240513

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗