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Набор скоро начнётся NCT06592157

Factors Influencing Wound Healing After Anal Fistula Surgery

— Наблюдательное Anal Fistula Surgery

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: NewEpi Plus Liquid Wound Dressing, standard wound care.
Кому может быть актуально
Состояния в реестре: Anal Fistula Surgery. 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
Список центров уточняется — проверьте первичный протокол.
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 objective of this observational study is to analyze the factors influencing wound healing after anal fistula surgery and to assess the effectiveness of interventions in improving overall patient outcomes post-surgery. The primary questions this study aims to answer are: 1. Does the use of the growth factor (New Epi) contribute to accelerating wound healing, reducing the risk of infection, and enhancing patient recovery speed after surgery? 2. Do other factors, such as infection, nutritional status, diabetes, surgical methods, patient age and overall health, immune status, and lifestyle habits, affect the healing of surgical wounds?

Вмешательства

  • Другое NewEpi Plus Liquid Wound Dressing
    1. Hold the spray nozzle 7-10 cm away from the wound. Apply the product evenly over the wound, with a dosage of one spray (0.1 ml) per 10x10 cm² of wound area. 2. Wait for 2 minutes. It is not necessary to wait until the solution is completely dry; you can proceed with applying ointments and various types of dressings as directed by the physician. 3. Use once a day for 21 days. The frequency of use can be adjusted according to the physician\'s instructions.
  • Другое standard wound care
    The standard wound care protocol aims to provide comprehensive and systematic care for patients to ensure smooth healing of surgical wounds. These care measures include regular cleaning, disinfection, dressing changes, and continuous observation and assessment of the wound condition. Through strict aseptic techniques and scientific care procedures, standard wound care effectively reduces the risk of infection and promotes wound healing.

Первичные конечные точки

  • Wound Healing Speed [Срок оценки: Day 7 and Day 21 after surgery]
  • Postoperative Pain Assessment [Срок оценки: 21 days (approximately three weeks of treatment)]
  • Daily Painkiller Usage [Срок оценки: 21 days (approximately three weeks of treatment)]
  • Complication Rate [Срок оценки: 21 days (approximately three weeks of treatment)]
Вторичные конечные точки (12)
  • Number of Participants Who Smoke [Срок оценки: At baseline (pre-surgery)]
  • Number of Participants with Alcohol Consumption [Срок оценки: At baseline (pre-surgery)]
  • Dietary Habits [Срок оценки: At baseline (pre-surgery)]
  • Sleep Patterns [Срок оценки: 21 days (approximately three weeks of treatment)]
  • Nutritional Status [Срок оценки: 21 days (approximately three weeks of treatment)]
  • HbA1C Levels to Assess Diabetes Control [Срок оценки: 21 days (approximately three weeks of treatment)]
  • BUN levels [Срок оценки: At baseline and Day 21 after surgery]
  • eGFR values [Срок оценки: At baseline and Day 21 after surgery]
  • creatinine levels [Срок оценки: At baseline and Day 21 after surgery]
  • AST (SGOT) levels [Срок оценки: At baseline and Day 21 after surgery]
  • ALT (SGPT) levels [Срок оценки: At baseline and Day 21 after surgery]
  • Total Bilirubin levels [Срок оценки: At baseline and Day 21 after surgery]

Критерии участия

Критерии включения

  • Patients over 18 years old.
  • Have undergone anal fistula surgery with complete surgical records.
  • No significant surgical contraindications, such as:Acute infection or inflammation,Severe cardiopulmonary insufficiency,Coagulation disorders,Immunodeficiency,Local skin lesions.
  • Understand and are willing to participate in the study.Willing to sign the informed consent form.

Критерии исключения

  • Patients under 18 years of age.
  • Pregnant or breastfeeding women.
  • Individuals with pre-existing severe heart, liver, or kidney diseases.
  • Individuals with active infections or systemic diseases.
  • Individuals who have previously undergone similar surgeries.
  • Individuals with immune dysfunction (such as HIV infection).

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06592157 · CG24317B

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗