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Идёт набор NCT07084740

Study and Modeling of Perforator Flap Vascularization

Без фазы С лечением Reconstructive Surgery Using Pedicled Perforating or Free Perforating Flaps Pelvic Eschar Traumatic Pathology of the Lower and/or Upper Limb

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: PeriCam and PeriFlux measurements.
Кому может быть актуально
Состояния в реестре: Reconstructive Surgery Using Pedicled Perforating or Free Perforating Flaps, Pelvic Eschar, Traumatic Pathology of the Lower and/or Upper Limb. Базовые параметры: 18 лет — 70 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
Франция
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 aim of reconstructive surgery is to restore physical integrity altered by trauma, congenital malformations or cancerous pathologies. Several techniques are available, including flap surgery, which enables tissue to be moved from one anatomical location to another. Perforating skin/subcutaneous flaps are segments of skin and subcutaneous cellular tissue vascularized by a feeder vascular pedicle. This surgical technique has virtually zero donor-site morbidity, as it is no longer necessary to harvest muscle to ensure reliable vascularization of the flap. Flap vascularization is a variable mechanism, complex to describe and understand. For cutaneous and subcutaneous (fatty) flaps, which account for the majority of flaps used, perforator flaps (vascularized by a subcutaneous perforator artery) have become the benchmark. Unfortunately, their vascularization is currently poorly understood, and depends on experimental work carried out on fresh cadaveric anatomical specimens. These cadaveric studies fail to take into account several key factors influencing perforasomes (perforasome: skin territory vascularized by a pedicle), namely body temperature, blood pressure, heart rate, intraoperative patient position and biological parameters.

Вмешательства

  • Диагностический тест PeriCam and PeriFlux measurements
    PeriCam and PeriFlux measurements

Первичные конечные точки

  • study the superficial tissue perfusion of flaps (flow speed) [Срок оценки: Between Day -1 and Day +1 of surgery]
  • study the superficial tissue perfusion of flaps (flow speed) [Срок оценки: Between Day -1 and Day +1 of surgery]
  • study the superficial tissue perfusion of flaps (Infusion quality) [Срок оценки: Between Day -1 and Day +1 of surgery]
  • study the superficial tissue perfusion of flaps (Infusion quality) [Срок оценки: Between Day -1 and Day +1 of surgery]
  • study the superficial tissue perfusion of flaps (Oxygenation quality) [Срок оценки: Between Day -1 and Day +1 of surgery]
  • study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale) [Срок оценки: Between Day -1 and Day +1 of surgery]
Вторичные конечные точки (12)
  • study the superficial tissue perfusion of flaps (flow speed) [Срок оценки: Between Day -1 and Day +3 of surgery]
  • study the superficial tissue perfusion of flaps (flow speed) [Срок оценки: Between Day -1 and Day +3 of surgery]
  • study the superficial tissue perfusion of flaps (flow speed) [Срок оценки: Between Day -1 and Day +30 of surgery]
  • study the superficial tissue perfusion of flaps (flow speed) [Срок оценки: Between Day -1 and Day +30 of surgery]
  • study the superficial tissue perfusion of flaps (Infusion quality) [Срок оценки: Between Day -1 and Day +3 of surgery]
  • study the superficial tissue perfusion of flaps (Infusion quality) [Срок оценки: Between Day -1 and Day +3 of surgery]
  • study the superficial tissue perfusion of flaps (Infusion quality) [Срок оценки: Between Day -1 and Day +30 of surgery]
  • study the superficial tissue perfusion of flaps (Infusion quality) [Срок оценки: Between Day -1 and Day +30 of surgery]
  • study the superficial tissue perfusion of flaps (Oxygenation quality) [Срок оценки: Between Day -1 and Day +3 of surgery]
  • study the superficial tissue perfusion of flaps (Oxygenation quality) [Срок оценки: Between Day -1 and Day +30 of surgery]
  • study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale) [Срок оценки: Between Day -1 and Day +3 of surgery]
  • study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale) [Срок оценки: Between Day -1 and Day +30 of surgery]

Критерии участия

Критерии включения

  • Age between 18 and 70
  • Reconstructive surgery using pedicled perforating flap or free perforating flap.
  • Flap with a surface area of at least 50 cm2 (in order to have a sufficiently large surface area for good perfusion visualization)
  • Pedicled perforating flaps group: Patients with pelvic eschar
  • Free perforating flaps group: Traumatic pathology of the lower and/or upper limb

Критерии исключения

  • No consent obtained
  • No social security affiliation
  • Persons under court protection
  • Persons participating in another study with an exclusion period still in progress

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Франция · 1 центр
  • University Hospital Montpellier — Montpellier

Идентификаторы

NCT: NCT07084740 · RECHMPL25_0082 · 2025-A00951-48

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗