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Идёт набор NCT07104084

Influence of Antiseptic Washes on Wound Healing Complications After THA

Без фазы С лечением Hip Osteoarthritis Avascular Necrosis of Femur Head

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: lavage chlorhexidine, lavage povidone-iodine.
Кому может быть актуально
Состояния в реестре: Hip Osteoarthritis, Avascular Necrosis of Femur Head. 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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Официальное название

Comparison of Wound Healing Complications After Anterior Total Hip Arthroplasty Using Povidone-iodine or Chlorhexidine as Antiseptic Wash

Обзор

The purpose of this research trial is to evaluate the effect of two types of washing solutions on wound healing after total hip replacement surgery. Washing solutions are used routinely during total hip replacements to clean the wound after the components have been placed and the wound is about to be closed with sutures. It is currently not known which washing solution may be better for wound healing and whether a certain solution decreases the risk of wound healing complications after total hip replacement. Therefore, this research trial is being conducted. Study participants will be randomized into one of two groups: washing the surgical wound with povidone-iodine solution (Surgiphor, Becton Dickinson, Franklin Lakes, NJ) or chlorhexidine solution (Irrisept, Irrimax Corporation, Lawrenceville, GA). All patients will undergo standard of care total hip replacements without any other change in surgery. The best type of solution that cleans the wound and potentially leads to better wound healing is unknown. This study will evaluate whether there is difference in surgical wound healing between the two washing solutions. The study will pay for the washing solutions. Patients will follow up for standard postoperative visits. At the 2-week and 6-week visits, pictures of the surgical incision will be taken and saved in the electronic medical record and evaluated in a standardized way for healing of the incision and the appearance of the scar. Postoperative complications and returns to the hospital or additional surgeries will be collected from the electronic medical record.

Подробное описание

Study participants will be randomized into one of two groups: washing the surgical wound with povidone-iodine solution (Surgiphor, Becton Dickinson, Franklin Lakes, NJ) or chlorhexidine solution (Irrisept, Irrimax Corporation, Lawrenceville, GA). All patients will undergo standard of care total hip replacements without any other change in surgery. The best type of solution that cleans the wound and potentially leads to better wound healing is unknown. This study will evaluate whether there is difference in surgical wound healing between the two washing solutions. Patients will follow up for standard postoperative visits. At the 2-week and 6-week visits, pictures of the surgical incision will be taken and saved in the electronic medical record and evaluated in a standardized way for healing of the incision and the appearance of the scar. Postoperative complications and returns to the hospital or additional surgeries will be collected from the electronic medical record.

Вмешательства

  • Устройство lavage chlorhexidine
    Patient will receive a chlorhexidine lavage for 3 minutes following total hip component placement followed by saline lavage.
  • Устройство lavage povidone-iodine
    Patient will receive povidone-iodine lavage for 3 minutes following total hip component placement followed by saline lavage.

Первичные конечные точки

  • Patient and Observer Scar Assessment Scale [Срок оценки: 2 weeks and 6 weeks postop]
Вторичные конечные точки (2)
  • wound healing complications [Срок оценки: up to 90 days from surgery]
  • Revision [Срок оценки: up to 90 days from surgery]

Критерии участия

Критерии включения

  • osteoarthritis or avascular necrosis of the femoral head, failed conservative management, indicated for total hip replacement

Критерии исключения

  • reported or documented allergy to chlorhexidine or povidone-iodine

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
Профилактика

Центры проведения

США · 2 центра
  • UPMC East — Monroeville
  • UPMC Shadyside — Pittsburgh

Идентификаторы

NCT: NCT07104084 · STUDY25020138

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗