Sternal Plating High Risk
- Conditions
- Heart Diseases
- Registration Number
- NCT06660186
- Lead Sponsor
- University Hospitals Cleveland Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Sternal healing as measured by CT scan 6 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 report 6 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 cost 6 months Index hospitalization costs (beginning at the time of surgery and ending at initial discharge)
Total cost 6 months All costs after initial discharge through 6 months
- Secondary Outcome Measures
Name Time Method Change in pain as measured by the Wong-Baker pain scale Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months From a scale of 0 (no hurts) to 10 (hurts worst)
Change in prescribed narcotic use as measured by patient report Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months Evaluating mean morphine equivalent
Change in upper extremity functional index (UEFI) Discharge (up to 10 days), 1 month, 6 months The UEFI is a validated 20 item questionnaire used for quantifying UEF in performing normal daily activities.
Change in quality of life as measured by the EuroQol EQ-5D-5L Discharge (up to 10 days), 1 month, 6 months The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Number of adverse events as measured by patient report Up to 6 months Adverse events of interest not specified above include: damage to soft tissue, organs, or surrounding structures during closure, need for reoperation, loosening of the wires, screws, or plates, fracture of the wires, screws, or plates, and need for hardware removal (wires, screws, or plates).
Trial Locations
- Locations (1)
University Hospitals
🇺🇸Cleveland, Ohio, United States