Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction
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: silk fibroin-based incision dressing, cyanoacrylate-based closure system.
- Кому может быть актуально
- Состояния в реестре: Anterior Cruciate Ligament Reconstruction. Базовые параметры: 14 лет — 60 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
- США
- 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
Prospective Evaluation of Silk Fibroin Versus 2-Octyl Cyanoacrylate Incision Dressings Following ACL Reconstruction
Обзор
The purpose of this study is to compare the incidence of early postoperative skin complications including allergic contact dermatitis, blistering, and erythema between silk fibroin incision dressings and cyanoacrylate closure in patients undergoing anterior cruciate ligament reconstruction.
Подробное описание
This is a prospective, randomized, parallel-group controlled trial conducted at a single academic medical center comparing a silk fibroin adhesive incision dressing (SYLKE) to a cyanoacrylate-based skin closure system (Dermabond or Prineo) in patients undergoing primary or revision anterior cruciate ligament reconstruction (ACLR). Participants are randomized 1:1 using a computer-generated allocation sequence stratified by operating surgeon. Wound closure is standardized across all participants prior to dressing application, ensuring that deep and dermal closure are identical between groups and independent of allocation.
The primary outcome is the incidence of early postoperative skin complications, including allergic contact dermatitis, blistering, erythema, and other incision-related complications, assessed at the first postoperative visit (7-14 days). Secondary outcomes include patient-reported comfort, itch, incision-site pain, satisfaction, and rehabilitation interference at approximately 30 days; dressing-related complications requiring clinical intervention through 30 days, captured via blinded electronic medical record review; and scar quality at a minimum of 3 months postoperatively using the Patient and Observer Scar Assessment Scale (POSAS v2.0), with the observer component scored by one unblinded clinical assessor and two fully blinded independent raters.
Вмешательства
- Устройство silk fibroin-based incision dressing
Applied sterile, hydrophobic, hypoallergenic dressing remains in place for 14-21 days, unless removal is clinically indicated (e.g., saturation, detachment, suspected allergic contact dermatitis, or at provider discretion). - Устройство cyanoacrylate-based closure system
Applied per standard NYU practice; dressing remains in place per routine protocol.
Первичные конечные точки
- Incidence rate of postoperative skin complications [Срок оценки: Follow-up 1 (7-14 days postoperatively)]
Вторичные конечные точки (7)
- Participant reported comfort rating (VAS) [Срок оценки: Approximately 30 days postoperatively]
- Participant-reported itch rating (VAS) [Срок оценки: approximately 30 days postoperatively]
- Rehabilitation Interference score [Срок оценки: approximately 30 days postoperatively]
- Participant-reported incision-site pain rating (VAS) [Срок оценки: approximately 30 days postoperatively]
- Overall participant satisfaction rating (VAS) [Срок оценки: approximately 30 days postoperatively]
- Participant and observer scar quality (POSAS v2.0) [Срок оценки: 3 Months Post-Operatively]
- Dressing-related complications requiring intervention. [Срок оценки: approximately 30 days postoperatively]
Критерии участия
Критерии включения
- Age 14 to 60 years
- Scheduled for primary or revision ACL reconstruction (ACLR)
- Able and willing to provide informed consent (≥18 years) or assent with parental/guardian permission (ages 14-17)
- Able and willing to comply with all study-related procedures and follow-up visits
Критерии исключения
- Active dermatologic conditions at or near the surgical site (e.g., eczema, psoriasis, dermatitis, open wounds)
- Immunocompromised state (e.g., uncontrolled HIV, ongoing chemotherapy, chronic corticosteroid therapy)
- Known or suspected allergy or hypersensitivity to silk fibroin or cyanoacrylate adhesives
- Uncontrolled diabetes (defined as most recent HbA1c ≥ 8.0, if available; not measured for study purposes)
- Active systemic infection at the time of enrollment
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
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
США · 1 центр
- NYU Langone Health — New York
Идентификаторы
NCT: NCT07217613 · 25-01002