Sternal Plating High Risk
ConditionHeart Diseases
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Rigid Sternal Fixation
DeviceThe 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.
Wire Cerclage
DeviceThe 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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Rigid Sternal FixationExperimental treatment 1 intervention
Group B: Wire CerclageActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sternal healing as measured by CT scan
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).
Time frame
6 months2
Number of sternal wound complications as measured by patient/physician report
Sternal wound complications will be a composite of wound dehiscence, sternal dehiscence, SSIs, and DSWIs (synonymous with deep SSIs and mediastinitis).
Time frame
6 months3
Total index hospitalization cost
Index hospitalization costs (beginning at the time of surgery and ending at initial discharge)
Time frame
6 months4
Total cost
All costs after initial discharge through 6 months
Time frame
6 monthsSecondary outcomes
1
Change in pain as measured by the Wong-Baker pain scale
From a scale of 0 (no hurts) to 10 (hurts worst)
Time frame
Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months2
Change in prescribed narcotic use as measured by patient report
Evaluating mean morphine equivalent
Time frame
Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months3
Change in upper extremity functional index (UEFI)
The UEFI is a validated 20 item questionnaire used for quantifying UEF in performing normal daily activities.
Time frame
Discharge (up to 10 days), 1 month, 6 months4
Change in quality of life as measured by the EuroQol EQ-5D-5L
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.
Time frame
Discharge (up to 10 days), 1 month, 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospitals Cleveland Medical Center
Lead sponsor
Stryker Nordic
Collaborator
Source ClinicalTrials.gov