Sternal Plating High Risk

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity Hospitals Cleveland Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

Undergoing cardiac surgery through sternotomy

Diabetes mellitus

Severe COPD

Chronic steroid use

Disqualifiers

Active malignancy

Chronic narcotic use

NYHA Class IV

Known nickel metal allergy

Trial design

Treatments tested in this trial

  • Rigid Sternal Fixation
  • Wire Cerclage

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators