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| Name | Class |
|---|---|
| Fundacio Privada Mon Clinic Barcelona | OTHER |
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The goal of this clinical trial is to learn if a new medical device (SC03 plates) to close the sternum after a sternotomy in patients that have been operated of a cardiac surgery, is safe and effective. The main question it aims to answer is:
Do patients that have the sternum closed with the SC03 plates present a stable sternum one month after surgery?
Researchers will compare the SC03 plates with stainless steel wires (current standard of care to close the sternum).
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC03 plates | Experimental | Adjustable carbon fiber sternal plates |
|
| Wires | Active Comparator | Stainless steel sternal wires |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SC03 Plating system | Device | Adjustable carbon fiber sternal plates |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sternal stability | Sternal stability measured by clinical assessment using the sternal instability scale (SIS), with grades 0 to 3 where 0 is "Clinically stable sternum" and 3 is "Completely separated sternum - entire length" | 1 month post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the SC03 Plating System | Incidence of Device Deficiencies, AE and SAE with a possible, probable or causal relationship with the device or the procedure. | Perioperative, 1 month and 6 months postoperatively. |
| Reinterventions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laia Rofes, PhD | Contact | +34935944726 | lrofes@neosurgery.com |
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| Stainless steel wires |
| Device |
Nonabsorbable, sterile, surgical sutures used in sternal closure |
|
Incidence and cause of surgical reinterventions
| 1 month and 6 months postoperatively |
| Infections | Incidence of sternal superficial and deep wound infections (mediastinitis) | First month and six months postoperatively. |
| Sternal dehiscence | Incidence of sternal dehiscence (without infection) | First month and six months postoperatively |
| Sternotomy closure duration | Duration of sternotomy closure procedure (minutes) | Surgery |
| Easiness of use of the closure method | Surgeon-reported ease of use and satisfaction score (Likert Scale, from 1 to 5) | Surgery |
| Sternal Pain | Patient-reported sternal pain at rest and during forced cough, measured by Numerical Rating Scale (0-10) | Baseline, 7 days, 1 month and 6 months postoperatively. |
| Analgesia required | Type and cumulative dose of analgesia (total morphine milligram equivalents (MME)) | Day 7, 1 month and 6 months postoperatively |
| Post-surgery blood loss | Chest tube drainage (mL) | 12 hours postoperatively |
| Blood loss | Haemoglobin drop (g/dL) | 48 hours after surgery |
| Blood loss | Number of administered perioperative blood transfusions of packed red blood cells | 48 hour after surgery |
| Intensive Care Unit stay duration | Intensive Care Unit stay duration (hours) | from surgery date to Intensive care unit discharge date (up to 150 days)] |
| hospitalization duration | hospitalization duration (days) | from surgery date to hospital discharge date (up to 150 days) |
| sternal stability | Sternal stability clinically assessed with the sternal instability scale (from 0 to 3) | 7 days and 6 months postoperatively |
| Upper Limb functional index | Patients will assess their upper limbs functional capacity using the Upper Limb functional index (ULFI-Sp) | Before surgery, one month and 6 months postoperatively |
| Quality of life - EQ5D5L | Patients will complete the EQ-5D-5L questionnaire | Before surgery, one month and 6 months postoperatively |
| Chest bulging | Presence of visible bulging related to the sternal closure method on the sternotomy area | 1 month after surgery |
| Pulmonary function | Pulmonary function (FVC, FEV1 and FEV1/FVC) measured by spirometry | Baseline, day 7 and 1 month postoperatively |