Sternotomy Closure,Open Heart Surgery
Conditions
Brief summary
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: * be implanted with the SC03 or stainless steel wires. * visit the clinic one month and six months after surgery * Keep a diary of their symptoms and analgesia use
Interventions
DEVICESC03 Plating system
Adjustable carbon fiber sternal plates
DEVICEStainless steel wires
Nonabsorbable, sterile, surgical sutures used in sternal closure
Sponsors
NEOS Surgery
Fundacio Privada Mon Clinic Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient ≥ 18 years old. * Patient who must undergo surgery in which a median or an upper partial sternotomy is indicated. * Patients capable of giving their voluntary informed consent to participate in the clinical investigation and from whom written consent has been obtained. * Patient able and willing to meet the protocol requirements and to follow postoperative care instructions
Exclusion criteria
* Patient with sternal anomalies, such as bone tumours located in the sternum. * Patient with limited sternum bone blood supply. * Patient with suspected or known allergies or intolerances to the implants materials: PEEK, carbon fibre, titanium, stainless steel. * Patient with severe osteoporosis or other degenerative bone diseases that affect the sternum. * Pregnant or breastfeeding patient or patient planning to become pregnant during the first 6 months after surgery. * Patient who is currently using opioid analgesics (e.g., morphine, oxycodone, hydrocodone, fentanyl, tramadol) for the management of chronic or acute pain. * Patient with diagnosis of dementia with a mental status score (MMSE) \< 20. * Patient with life expectancy lower than 6 months. * Patient with any other medical process that may compromise or limit the adequate functionality of the implants. * Patient involved in other interventionist clinical trial or that have been involved in other interventionist clinical trial during the previous 4 weeks. * Patient with signs of latent or active infection or inflammation on the surgical site. * Patient with insufficient quantity or quality of sternum bone, or other severe structural bone damage. * Patient for whom the closure technique cannot ensure sufficient sternal fixation. * Parasternal sternotomy. * Patient with intraoperative conditions that may compromise or limit the adequate functionality of the implants or that may prevent the surgeon to use the sternal closure system or that cannot be closed following the product instructions for use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sternal stability | 1 month post operatively | 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" |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the SC03 Plating System | Perioperative, 1 month and 6 months postoperatively. | Incidence of Device Deficiencies, AE and SAE with a possible, probable or causal relationship with the device or the procedure. |
| Reinterventions | 1 month and 6 months postoperatively | Incidence and cause of surgical reinterventions |
| Infections | First month and six months postoperatively. | Incidence of sternal superficial and deep wound infections (mediastinitis) |
| Sternal dehiscence | First month and six months postoperatively | Incidence of sternal dehiscence (without infection) |
| Sternotomy closure duration | Surgery | Duration of sternotomy closure procedure (minutes) |
| Easiness of use of the closure method | Surgery | Surgeon-reported ease of use and satisfaction score (Likert Scale, from 1 to 5) |
| Sternal Pain | Baseline, 7 days, 1 month and 6 months postoperatively. | Patient-reported sternal pain at rest and during forced cough, measured by Numerical Rating Scale (0-10) |
| Analgesia required | Day 7, 1 month and 6 months postoperatively | Type and cumulative dose of analgesia (total morphine milligram equivalents (MME)) |
| Post-surgery blood loss | 12 hours postoperatively | Chest tube drainage (mL) |
| Blood loss | 48 hours after surgery | Haemoglobin drop (g/dL) |
| Intensive Care Unit stay duration | from surgery date to Intensive care unit discharge date (up to 150 days)] | Intensive Care Unit stay duration (hours) |
| hospitalization duration | from surgery date to hospital discharge date (up to 150 days) | hospitalization duration (days) |
| sternal stability | 7 days and 6 months postoperatively | Sternal stability clinically assessed with the sternal instability scale (from 0 to 3) |
| Upper Limb functional index | Before surgery, one month and 6 months postoperatively | Patients will assess their upper limbs functional capacity using the Upper Limb functional index (ULFI-Sp) |
| Quality of life - EQ5D5L | Before surgery, one month and 6 months postoperatively | Patients will complete the EQ-5D-5L questionnaire |
| Chest bulging | 1 month after surgery | Presence of visible bulging related to the sternal closure method on the sternotomy area |
| Pulmonary function | Baseline, day 7 and 1 month postoperatively | Pulmonary function (FVC, FEV1 and FEV1/FVC) measured by spirometry |
Contacts
CONTACTLaia Rofes, PhD
Outcome results
None listed