Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure

Официальное название

Clinical Investigation to Evaluate the Use of Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure

Обзор

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

Вмешательства

• Устройство SC03 Plating system
  Adjustable carbon fiber sternal plates
• Устройство Stainless steel wires
  Nonabsorbable, sterile, surgical sutures used in sternal closure

Первичные конечные точки

• Sternal stability [Срок оценки: 1 month post operatively]

Вторичные конечные точки (12)

• Safety of the SC03 Plating System [Срок оценки: Perioperative, 1 month and 6 months postoperatively.]
• Reinterventions [Срок оценки: 1 month and 6 months postoperatively]
• Infections [Срок оценки: First month and six months postoperatively.]
• Sternal dehiscence [Срок оценки: First month and six months postoperatively]
• Sternotomy closure duration [Срок оценки: Surgery]
• Easiness of use of the closure method [Срок оценки: Surgery]
• Sternal Pain [Срок оценки: Baseline, 7 days, 1 month and 6 months postoperatively.]
• Analgesia required [Срок оценки: Day 7, 1 month and 6 months postoperatively]
• Post-surgery blood loss [Срок оценки: 12 hours postoperatively]
• Blood loss [Срок оценки: 48 hours after surgery]
• Blood loss [Срок оценки: 48 hour after surgery]
• Intensive Care Unit stay duration [Срок оценки: from surgery date to Intensive care unit discharge date (up to 150 days)]]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07366203 · NEO-SC3-2025-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗