Меню
Идёт набор NCT05713149

Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents

— Наблюдательное Disability or Chronic Disease Leading to Disablement Pressure Ulcer Osteomyelitis

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: Surgical flap and anti-bacterial agents.
Кому может быть актуально
Состояния в реестре: Disability or Chronic Disease Leading to Disablement, Pressure Ulcer, Osteomyelitis. 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents in Patients Patients With Neuromotor Disability : a Prospective Cohort Study

Обзор

People with neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at high risk of osteomyelitis-associated pressure ulcers. The management of osteomyelitis-associated pressure ulcers is controversial. In our center, patients benefit from a one stage surgical management with bone shaving and flap covering osteitis of pressure ulcer to perform wound closing. Surgery is followed by an antibiotic treatment, secondarily adapted to intraoperative samples. The aim of this study is to describe the cohort and to identify factors associated with failure (or success) in this frail population.

Подробное описание

This is a prospective, monocentric, cohort study of neurological disabled inpatients subjects treated in the perioperative disability unit (UPOH) of our university hospital for osteomyelitis-associated pressure ulcer by surgical flaps and anti bacterial agents.

All eligible inpatient subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers by surgical flaps will be consecutively included.

Patients are followed up in consultation at 30 or 45 days after surgery, and in consultation or teleconsultation at 12 months after surgery.

Data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological, and physiological examinations. Data related to sitting, nutrition, spasticity, bladder and bowel disorders, bacteriological sampling and antibiotic treatments will be collected.

This is a routine care study; no procedures are added for research purposes. It is an ancillary study to the NO-AGING study.

Вмешательства

  • Другое Surgical flap and anti-bacterial agents
    Surgical flap and anti-bacterial agents

Первичные конечные точки

  • Success at 12 months after surgery [Срок оценки: 12 months after surgery]
Вторичные конечные точки (3)
  • Success at 30-45 days after surgery [Срок оценки: 30-45 days after surgery (depening on the surgical technique)]
  • Description of the patients' bacteriological tests [Срок оценки: Through hospital admission, up to 7 days after surgery]
  • Death [Срок оценки: 12 months after surgery]

Критерии участия

Критерии включения

  • Patients >= 18 years old ;
  • Treated in the Perioperative Disability Unit (UPOH) of the Physical Medicine and Rehabilitation Department of our university hospital;
  • Admitted for the treatment of an osteomyelitis-associated pressure ulcer by surgical flap;
  • Having a neuromotor disability;
  • No opposition to be enrolled in the study from the patient, or from a legally authorized close relative if the patient's state of health does not allow it;
  • Affiliation to a social security scheme.

Критерии исключения

  • Under court protection.

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP — Garches

Идентификаторы

NCT: NCT05713149 · 2023-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗