Sternal Plating High Risk Study
This study at University Hospitals is for people with heart disease who are having open heart surgery. After surgery, your breastbone (sternum) needs to be closed. Doctors currently use two methods: the SternalPlate system (rigid plates) or Wire Cerclage (wires). This study aims to compare these two techniques to see which works best. You might be able to join if you are 18 to 89 years old, are having cardiac surgery, and have certain risk factors for problems with your sternal wound, such as diabetes or severe COPD. The study will look at how well your sternum heals and how many wound complications occur, as well as the cost of your hospital stay, all measured at 6 months after surgery. The study is planning to enroll 250 participants, but the current recruitment status is unclear.
- Study design
- This is an interventional study comparing two methods of closing the breastbone after heart surgery: the SternalPlate system and Wire Cerclage. It plans to enroll 250 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after surgery to assess sternal healing, wound complications, and hospitalization costs.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Sternal Plating High Risk
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Marc Pelletier, MD · PRINCIPAL_INVESTIGATOR · University Hospitals
- Rakesh Arora, MD · PRINCIPAL_INVESTIGATOR · University Hospitals
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Sternal healing as measured by CT scan6 months
5 axial CT slices from a priori-defined anatomic locations are selected by a radiologist. Two additional radiologists then independently score each location using a 6-point scale (0, 1, 2, 3, 4, or 5) with higher scores representing greater healing. Sternal union will be pre-specified as a mean score ≥3 (total score ≥15).
- Number of sternal wound complications as measured by patient/physician report6 months
Sternal wound complications will be a composite of wound dehiscence, sternal dehiscence, SSIs, and DSWIs (synonymous with deep SSIs and mediastinitis).
- Total index hospitalization cost6 months
Index hospitalization costs (beginning at the time of surgery and ending at initial discharge)
- Total cost6 months
All costs after initial discharge through 6 months