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Идёт набор NCT07460323

Study of TRE Seals on Early Post-operative Subjects

Без фазы С лечением Ostomy

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: An Ostomy Seal, An Ostomy Ring.
Кому может быть актуально
Состояния в реестре: Ostomy. Базовые параметры: 18 лет — 85 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
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study will evaluate two Ostomy Seals/Rings in a group of post-operative patients.

Вмешательства

  • Устройство An Ostomy Seal
    An absorptive ostomy seal
  • Устройство An Ostomy Ring
    The Ostomy Ring contains Aloe

Первичные конечные точки

  • The Risk of Peristomal Skin Complications (PSCs) as measured using the three PSC-related questions on the Ostomy Complication Severity Index (OCSI) [Срок оценки: From enrollment to the end of treatment at 9 weeks]
Вторичные конечные точки (12)
  • Total Ostomy Complication Severity Index (OCSI) score and six stomal complication (non-PSC) domains of the OCSI and associated severity [Срок оценки: From enrollment to the end of treatment at 9 weeks]
  • Mediation of peristomal skin complications (PSCs) by leakage absorption measured using the leakage item on the Ostomy Complication Severity Index (OCSI) [Срок оценки: From enrollment to the end of treatment at 9 weeks]
  • Visible moisture/effluent on peristomal skin under the study seal area (OCSI Supplementary Question) [Срок оценки: From enrollment to the end of treatment at 9 weeks]
  • Seal absorption of moisture/effluent under the study seal area (OCSI Supplementary Question) [Срок оценки: From enrollment to end of treatment at 9 weeks]
  • Presence of peristomal skin conditions (OCSI Supplementary Question) [Срок оценки: From enrollment to end of treatment at 9 weeks]
  • Peristomal skin burning severity (OCSI Supplementary Question) [Срок оценки: From enrollment to end of treatment at 9 weeks]
  • Peristomal skin itching severity (OCSI Supplementary Question) [Срок оценки: From enrollment to end of treatment at 9 weeks]
  • Time to resolution of peristomal skin complications (PSCs), assessed by the Ostomy Complication Severity Instrument (OCSI) at visits and adverse event (AE) reports between visits [Срок оценки: From first PSC onset to resolution through end of treatment at 9 weeks]
  • Time to recurrence of peristomal skin complications (PSCs) after resolution, assessed by the OCSI at visits and AE reports between visits [Срок оценки: From PSC resolution to first recurrence through end of treatment at 9 weeks]
  • Proportion of participants with PSC occurrence, PSC resolution, and PSC recurrence, assessed by the OCSI at visits and AE reports between visits [Срок оценки: From enrollment to end of treatment at 9 weeks]
  • Patient satisfaction with the study Seal/Ring assessed using the Study-Specific Patient Satisfaction Questionnaire (Likert scale) [Срок оценки: From enrollment to the end of treatment at 9 weeks]
  • Clinician Satisfaction with the study Seal/Ring assessed using the Study-Specific Clinician Satisfaction Questionnaire (Likert scale) [Срок оценки: From enrollment to the end of treatment at 9 weeks]

Критерии участия

Критерии включения

  • At least 18 years of age
  • Has their ostomy surgery and post-operative care in the United Kingdom (UK)
  • Has a colostomy, ileostomy, or urostomy and no reversal planned during the study evaluation period
  • Able to have first study product applied at first pouch change after surgery (or up to 4 days post-op)
  • Is appropriate to use a barrier seal per the Investigator
  • Able to provide an informed consent for study participation
  • Willing to follow protocol procedures, including participating in study visits, as demonstrated by signing the informed consent

Критерии исключения

  • Is over 85 years of age
  • Has received chemotherapy or radiation in the past 30 days or reports beginning chemotherapy or radiation during the study.
  • A score of 1, 2, or 3 for any of the three OCSI Tool PSC-related domains (i.e., peristomal irritant dermatitis, peristomal bleeding, and hyperplasia) at time of enrollment
  • Has a fistula in the peristomal area at time of enrollment
  • Has an open draining wound (not including mucocutaneous separation) in the peristomal area at time of enrollment
  • Has a suspected infection in the peristomal area at time of enrollment
  • Is pregnant or lactating at time of enrollment (as determined by interview only)
  • Is unable to speak, read, and understand English.
  • Is currently participating in another clinical study using ostomy products
  • Is currently an employee of Hollister Incorporated or any ostomy manufacturer

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
Открытое
Основная цель
Профилактика

Центры проведения

Великобритания · 6 центров
  • North Tees University Hospital — Stockton-on-Tees
  • East Sussex Healthcare NHS Trust: Conquest and Eastbourne Hospitals — Saint Leonards-on-Sea
  • William Harvey Hospital — Ashford
  • Queen Elizabeth The Queen Mother Hospital — Margate
  • East Surrey Hospital — Redhill
  • University Hospital Coventry — Coventry

Идентификаторы

NCT: NCT07460323 · 6042-OST

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗