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Идёт набор NCT06614829

Patient Reported Experiences and Outcomes Associated with Standard C-Section Wound Closure Versus STRATAFIX/DERMABOND PRINEO Wound Closure (CS-PREO)

Без фазы С лечением Cesarean Section; Complications, Wound, Infection (Following Delivery)

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: Stratafix Suture, DERMABOND PRINEO.
Кому может быть актуально
Состояния в реестре: Cesarean Section; Complications, Wound, Infection (Following Delivery). Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
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

Patient Reported Experiences and Outcomes Associated with C-Section Wound Closure Bundle

Обзор

The aim of the study is to compare outcomes between patients receiving standard C-section wound closure compared to a wound closure bundle that includes Stratafix sutures and Dermabond PRINEO.

Подробное описание

The purpose of this study is to evaluate patient experience and patient reported outcomes following cesarean delivery in women receiving either standard wound closure or a wound closure bundle which includes both Stratfix sutures and Dermabond Prineo.

Patients in both study arms will complete established questionnaires capturing patient-reported experience measures (PREMS) and patient-reported outcome measures (PROMS).

Вмешательства

  • Устройство Stratafix Suture
    Stratafix sutures are barbed and have an antimicrobial coating. The barbs maintain tension during and allows for knotless suturing. The antimicrobial coating inhibits bacterial colonization of the wound.
  • Устройство DERMABOND PRINEO
    DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive. It also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment until the liquid adhesive is applied to achieve skin closure. It forms a strong, flexible, waterproof microbial barrier-as long as the adhesive film remains intact-that falls off naturally after 7-14 days. Dermabond Prineo system will be applied to the skin for skin closure.

Первичные конечные точки

  • Canadian Patient Experiences Survey - Inpatient Care + maternity questions [Срок оценки: Assessed roughly 48-72 hours after C-section delivery]
  • SCAR-Q Scores [Срок оценки: Assessed at approximately 6 week follow-up appointment]
  • Diagnosed surgical site infection [Surgical site infection questionnaire completed at follow-up appointment] [Срок оценки: Assessed at approximately 6 week follow-up appointment]
  • Readmission to any hospital following birth [Surgical site infection questionnaire completed at follow-up appointment] [Срок оценки: Assessed at approximately 6 week follow-up appointment]
  • Antibiotic prescription for treatment of infection [Surgical site infection questionnaire completed at follow-up appointment] [Срок оценки: Assessed at approximately 6 week follow-up appointment]

Критерии участия

Критерии включения

  • Patient must be 18 years of age or older at time of recruitment
  • Patients opting for a planned (elective) C-Section (13-36 weeks gestation) will be eligible to consent.
  • Patients must have internet access and/or a smartphone in order to access the digital platform to complete the study questionnaires
  • Patients must speak and write in English as study questionnaires will only be provided in English
  • Patients must have coverage from the Ontario Health Insurance Plan (OHIP)

Критерии исключения

  • Patients assessed by the participating surgeon with any conditions that may compromise their:
  • Ability to consent or use the virtual care platform (e.g., patients with intellectual disabilities)
  • Expectation of significant maternal complications that may affect the surgery
  • Patients who enroll in the study but have an unplanned emergency C-section

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Канада · 1 центр
  • North York General Hospital — North York

Идентификаторы

NCT: NCT06614829 · 0434

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗