No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 89
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
250 (estimated)
Sponsor
University Hospitals Cleveland Medical Center · Other
Who this trial is looking for
This trial is looking for adults with heart disease who are having open heart surgery. Participants will help compare two methods for closing the sternum after surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 89 years old
I am having cardiac surgery through sternotomy
I have at least two risk factors for sternal wound complications
You may not be able to join if
I have active cancer
I use narcotics regularly
I have severe heart failure (NYHA Class IV)
I am allergic to nickel
I have a kidney function issue (eGFR < 30)
I am involved in another clinical trial
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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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 thera…
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
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