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Идёт набор NCT06297967

Acetic Acid 2% Solution for Skin Ulcers

Фаза III С лечением Ulcer, Skin

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: Acetic Acid, Prontosan.
Кому может быть актуально
Состояния в реестре: Ulcer, Skin. 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
Испания
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

Acetic Acid in Cutaneous Ulcers. A Randomized Controlled Trial

Обзор

The objective of this clinical trial is to assess the effectiveness of acetic acid in patients suffering from chronic cutaneous ulcers with biofilm. The primary question it seeks to address is whether acetic acid (as a 2% topical solution) is superior to the current standard treatment for chronic cutaneous ulcers with biofilm at our center (Prontosan®). Participants will be randomly assigned to receive either the acetic acid solution treatment or the standard current treatment.

Вмешательства

  • Препарат Acetic Acid
    The intervention treatment will consist of cleaning with water and soap, application of a compress soaked in 2% dilution of glacial acetic acid (CAS 64-19-7) for 15 minutes, irrigation with distilled water, application of peri-ulcer barrier cream or spray, and the application of ActicoatⓇ on the ulcer bed. Depending on the amount of exudate, more or less alginate will be added as a secondary dressing. A tertiary dressing of polyurethane foam or bandage will be applied according to the area and t
  • Препарат Prontosan
    The treatment includes ulcer cleansing with water and soap, application of ProntosanⓇ compress for 15 minutes, subsequent irrigation with distilled water, application of peri-ulcer barrier cream or spray, and the application of ActicoatⓇ on the wound bed. More or less alginate will be applied depending on the amount of exudate. A tertiary dressing of polyurethane foam or bandage will be applied according to the area and the nurse's discretion.

Первичные конечные точки

  • Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment [Срок оценки: 8 weeks]
Вторичные конечные точки (8)
  • Percentage of participants with ulcer healing at 4 weeks from the start of treatment. [Срок оценки: 4 weeks]
  • Percentage of participants with ulcer healing at 12 weeks from the start of treatment. [Срок оценки: 12 weeks]
  • Time (days) to ulcer healing from the start of treatment. [Срок оценки: up to 12 weeks]
  • Changes in the wound bed at 8 weeks according to score of section 6 of the RESVECH2.0 ("Expected Results of the Assessment and Evaluation of Healing of Chronic Wounds" scale. [Срок оценки: 8 weeks]
  • Number of adverse reactions associated with the treatment, collected from the medical record. [Срок оценки: 12 weeks]
  • The healthcare expenditure associated with each branch of the study [Срок оценки: 12 weeks]
  • Change in ulcer area compared to baseline (percentage) at 4 weeks of treatment [Срок оценки: 4 weeks]
  • Change in ulcer area compared to baseline (percentage) at 12 weeks of treatment [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Patients over 18 years of age.
  • Continued care (hospital or outpatient) in one of the Consorci Sanitari Alt Penedes i Garraf (CSAPG) units.
  • Presence of a cutaneous ulcer with biofilm, with an area of less than 120 cm2, and in any location (except the facial region).
  • Plan to undergo treatment and follow-up of the lesion (at least 8 weeks) at the study center.
  • Ability to cooperate in necessary evaluations.
  • Informed consent for inclusion in the study, either from the participant themselves or from their legal representative.

Критерии исключения

  • Participants diagnosed with any of the following conditions:
  • Ulcers with exposed bone tissue.
  • Neoplastic-origin ulcers.
  • Ulcers lasting more than 18 months.
  • Participation in another clinical trial involving an experimental intervention during the period of the current trial and/or establishing a visit frequency incompatible with the current trial.

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
Лечение

Центры проведения

Испания · 1 центр
  • Consorci Sanitari Alt'Pènedes i Garraf — Barcelona

Идентификаторы

NCT: NCT06297967 · CSAPG-33

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗