Clinical Efficacy of Self-adhesive Silicone Gel Waterproof Dressings Versus Conventional Dressings in the Healing of Incisions After Total Joint Arthroplasty
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: Self-adhesive silicone gel waterproof dressing, Sterile gauze dressing.
- Кому может быть актуально
- Состояния в реестре: Self-adhesive Silicone Gel Waterproof Dressing, Gauze Dressing, Total Joint Arthroplasty. Базовые параметры: 18 лет — 80 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
- Список центров уточняется — проверьте первичный протокол.
- 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
Clinical Efficacy of Self-adhesive Silicone Gel Waterproof Dressings Versus Conventional Dressings in the Healing of Incisions After Total Joint Arthroplasty: a Prospective, Randomized Controlled Trial Study
Обзор
The efficacy of using self-adhesive silicone gel waterproof dressings versus conventional gauze dressings for recovery after total joint arthroplasty (TJA) remains unclear. In our study, we conducted a prospective, randomized controlled trial to compare these two types of dressings. Patients were divided into two groups following TJA, and we collected primary outcome measures such as skin infection rate and re-operation rate. Additionally, we gathered blood inflammatory indicators, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), to evaluate the effectiveness of the two treatments. Finally, we perform one year follow up including REEDA score, MSS score to evaluate the recovery of the skin.
Вмешательства
- Устройство Self-adhesive silicone gel waterproof dressing
Self-adhesive silicone gel waterproof dressing is used after artificial joint replacement surgery. - Устройство Sterile gauze dressing
Sterile gauze dressing is used after artificial joint replacement surgery.
Первичные конечные точки
- Infection control rate [Срок оценки: One month and three month after surgery]
- Redness, Edema, Ecchymosis, Discharge, and Approximation score (REEDA score) [Срок оценки: One day before surgery, three month after surgery]
- Modified Severity Score (MSS) [Срок оценки: One day before surgery, three month after surgery]
Вторичные конечные точки (8)
- X-ray [Срок оценки: One day before surgery and three months after surgery.]
- American Knee Society Score (AKS score) [Срок оценки: One day before surgery and three months after surgery.]
- The Harris Hip Score (HHS) [Срок оценки: One day before surgery and three months after surgery.]
- Visual Analog Scale (VAS score) [Срок оценки: One day before surgery and three months after surgery.]
- Alanine Aminotransferase (ALT) [Срок оценки: One day before surgery and one day after surgery]
- Aspartate Aminotransferase (AST) [Срок оценки: One day before surgery and one day after surgery]
- Serum Creatinine [Срок оценки: One day before surgery and one day after surgery]
- Blood Urea Nitrogen （BUN） [Срок оценки: One day before surgery and one day after surgery]
Критерии участия
Критерии включения
- Age ≥18 years old, gender is not limited;
- Meet the diagnostic criteria for artificial joint replacement;
- Initial joint replacement surgery;
- Voluntary and signed informed consent.
Критерии исключения
- Allergic to self-adhesive silicone rubber waterproof dressing;
- Patients with severe knee joint infection who cannot undergo artificial joint replacement;
- Progressive renal insufficiency (stage 4 and above) or glomerular filtration rate less than 30ml/min;
- periprosthesis infection after multiple joint replacement;
- Active infection at the site of intravenous or joint injection;
- long-term use of anticoagulants or antiplatelet drugs due to other diseases;
- Have sepsis or positive blood culture within the last 30 days;
- Radiotherapy and chemotherapy are required due to neoplastic diseases;
- Receiving systemic glucocorticoid therapy (prednisone > 10mg/ day or equivalent hormone medication);
- severe immunodeficiency diseases (such as stage 3 HIV, sickle cell anemia, splenectomy, etc.);
- Have a history of drug abuse;
- Treatment of bone marrow or other transplants with immunosuppressive drugs;
- Pregnant, parturient and lactating women;
- Participating in other clinical trials;
- Researchers believe that other reasons are not appropriate for clinical trial participants.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06467721 · XJ202405-01