Heart Diseases
Conditions
Keywords
Cardiac Surgery, Wound Complication, Rigid Sternal Fixation, Sternal Infection, Pain, Non-union
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.
Interventions
DEVICERigid Sternal Fixation
The 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.
DEVICEWire Cerclage
The 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.
Sponsors
University Hospitals Cleveland Medical Center
Stryker Nordic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
CONTACTStacey Mazzurco
PRINCIPAL_INVESTIGATORMarc Pelletier, MD
University Hospitals
PRINCIPAL_INVESTIGATORRakesh Arora, MD
University Hospitals
Outcome results
None listed