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Идёт набор NCT06578650

A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms

— Наблюдательное Surgical Wound

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: Synthetic Electrospun Fiber Matrix.
Кому может быть актуально
Состояния в реестре: Surgical Wound. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this observational prospective study is to evaluate wound healing outcomes in resection wounds resulting from surgical removal of cutaneous malignancies treated with a synthetic electrospun fiber matrix. This study intends to quantify the time from initial resection and product application to time of complete granulation of the wound bed in weeks.

Вмешательства

  • Устройство Synthetic Electrospun Fiber Matrix
    Patients who are eligible for enrollment will be treated with Synthetic Electrospun Fiber Matrix immediately after surgical resection to the resulting wound

Первичные конечные точки

  • Time to wound bed granulation [Срок оценки: Weekly assessments until granulation achieved or up to 6 weeks following resection surgery]
Вторичные конечные точки (5)
  • Time to complete wound healing [Срок оценки: Until healed or until 16 weeks post resection]
  • Patient pain [Срок оценки: Weekly for up to six weeks post resection]
  • Time to skin grafting [Срок оценки: Weekly for up to 6 weeks post-resection]
  • Skin graft "take" rate [Срок оценки: 1 week after skin graft application]
  • Tissue flap take rate [Срок оценки: 1 week after tissue flap procedure]

Критерии участия

Критерии включения

  • Patient is at least 18 years old
  • Patient plans to undergo surgical resection of a cutaneous neoplasm
  • Patient is willing and capable of complying with all protocol requirements
  • Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to participation in study
  • Post-resection surgical wound with a surface area of ≥4 cm2 and ≤ 36cm2

Критерии исключения

  • Inability to give informed consent or to complete the procedures required for study completion
  • Patient has been previously enrolled into this study, or is currently participating in another drug or device study that has not reached its primary endpoint
  • Patient is pregnant, breast feeding or planning to become pregnant
  • Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
  • Patients receiving any immunotherapy, radiation, or chemotherapy within the past four weeks prior to resection surgery.
  • Patient has a life expectancy less than six months as assessed by the investigator
  • Patient has an additional non-study related wound within 3 cm of the study wound
  • Study wound is located on the hands or feet
  • Patient has been diagnosed with osteomalacia
  • Resection defect from a squamous cell carcinoma arising from a chronic wound
  • Patient has an uncontrolled thyroid disorder
  • Hgb A1c > 12% within 3 months prior to enrollment in patients with a known history of diabetes
  • Patient has a BMI > 34.9
  • Patient has used any tobacco product within the past 30 days prior to surgery
  • Patients with chronic kidney disease on peritoneal or hemodialysis, or with an estimated glomerular filtration rate less than 15mL/min
  • Patients with severe liver disease with active cirrhosis defined as a gross ascites upon clinical exam or a Model for End-stage Liver Disease (MELD)-Na score greater than 15
  • Patient not in reasonable metabolic control in the judgement of the investigator
  • Patient has a known history of poor compliance with medical treatment
  • Patient has a history of radiotherapy to wound bed of interest
  • Patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
  • Active infection, undrained abscess, or critical colonization of the wound with bacteria in the judgement of the investigator

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University Nevada - Las Vegas — Las Vegas

Идентификаторы

NCT: NCT06578650 · 24-RES-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗