Shockwave Intervention for Enhanced Wound Healing in No-touch Pedicle Saphenous Vein Graft Harvesting for Coronary Artery Bypass Grafting
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Shockwave treatment, Sham treatment.
- Кому может быть актуально
- Состояния в реестре: Coronary Arterial Disease (CAD). Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Австрия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Shockwave Intervention for Enhanced Wound Healing in No-touch Pedicle Saphenous Vein Graft Harvesting for Coronary Artery Bypass Grafting: A Prospective, Single-Center, Single-Blind, Randomized, Sham-Controlled Study
Обзор
The aim of this trial is to apply shockwaves to the leg wound after saphenous vein harvesting and closure in order to reduce the occurrence of postoperative wound healing complications following coronary artery bypass grafting using venous grafts.
Подробное описание
Selection of suitable grafts for coronary artery bypass grafting (CABG) is one of the most critical decisions cardiac surgeons must make. There are two main techniques for harvesting graft vessels. The first is the skeletonized harvesting technique (ST), in which only the vessel itself is dissected and isolated before removal. The second method is the "no-touch" technique (NT), where the vessel is harvested along with surrounding tissue to minimize direct manipulation and potential microtrauma to the graft.
Saphenous vein grafts (SVG) are the most commonly used conduits in CABG and can be harvested using either technique. While the NT technique has demonstrated superior long-term patency and reduced atherosclerotic changes, it is associated with a significantly higher rate of wound healing complications, which are often more severe and can have a considerable impact on patient quality of life.
Shockwave therapy (SWT) has been shown to accelerate wound healing. The SHIELDS-CABG trial employs a double-blinded, sham-controlled design to evaluate the efficacy of prophylactic SWT in reducing wound healing complications after NT saphenous vein harvesting in CABG patients. In this study, the intervention group receives SWT immediately after wound closure to enhance healing and prevent complications.
This is a prospective, single-center, single-blinded, randomized, sham-controlled trial conducted at the Department of Cardiac Surgery, Medical University of Innsbruck. Blinding is maintained intraoperatively and only applied after wound closure to avoid procedural bias. Half of the patients will receive SWT, while in the control group the device will be held over the wound for the same duration without delivering shockwaves. A double-blind design is not feasible, as the operating staff can hear the characteristic sound of the device during SWT application.
Вмешательства
- Устройство Shockwave treatment
The shockwave device will be set to an energy flux density of 0.1 mJ/mm² at 5 Hz, with approximately 25 impulses per centimeter of wound length. This means that one centimeter of the wound will be treated for 5 seconds. The shockwave treatment will then be carried out, with each centimeter of the wound area treated for 5 seconds using gentle circular motions. - Устройство Sham treatment
The applicator will not be connected to the shockwave device. The applicator treatment will then be carried out, with each centimeter of the wound area treated for 5 seconds using gentle circular motions.
Первичные конечные точки
- Wound Healing Disturbance [Срок оценки: 30 days after surgery]
Вторичные конечные точки (9)
- Bates-Jensen Wound Assessment Tool [Срок оценки: From randomization to the end of participation at 180 days]
- Change in EQ-5D-5L Index Score [Срок оценки: From randomization to end of study participation at 180 days]
- Unscheduled visits [Срок оценки: From randomization to end of study participation at 180 days]
- Surgical revision [Срок оценки: From randomization to end of study participation at 180 days]
- Antibiotics due to wound healing [Срок оценки: From randomization to end of study participation at 180 days]
- Discharge wound state [Срок оценки: From randomization to discharge (Day 8±3)]
- Laboratory values [Срок оценки: From randomization to end of study participation at 180 days]
- Adverse events [Срок оценки: From randomization to end of study participation at 180 days]
- Serious Adverse Events [Срок оценки: From randomization to end of study participation at 180 days]
Критерии участия
Критерии включения
- Male or female patients > 18 years
- Isolated CABG procedure in the need of 2 or more venous grafts
- Elective or urgent cases
- Median sternotomy approach
- eGFR ≥ 15 ml/min
- Willing to participate in trial
- Able to provide informed consent
Критерии исключения
- History of venous stripping or ligation
- Uncontrolled Diabetes mellitus (HbA1c ≥ 9 %)
- Enrolled in other therapeutic or interventional trial
- Hemodynamically unstable
- Cardiogenic shock
- Any condition that seriously increases the risk of noncompliance or loss of follow-up
- Emergency case
- Salvage case
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Профилактика
Центры проведения
Австрия · 1 центр
- Department of Cardiac Surgery, Medical University Innsbruck — Innsbruck
Идентификаторы
NCT: NCT07068776 · 1054/2025