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Идёт набор NCT07391735

Post-Surgery Wound Healing Tracking With MyHealthPal App

Без фазы С лечением Wound Infection and Wound Healing

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: MyHealthPal App.
Кому может быть актуально
Состояния в реестре: Wound Infection and Wound Healing. 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
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Официальное название

Postoperative Pain Procedure Patient Remote Monitoring With MyHealthPal Clinical Study

Обзор

The investigators want to explore the use of a smartphone app that allows patients to take photos of their wounds in early stages of healing, so that clinicians can monitor wound-healing remotely with the assistance of an AI program. Participants will choose whether they want to be in the control group or the app group. Participants in the app group will be asked to download an app on their personal smartphone before their surgery. After the procedure, participants will upload a photo of their surgery site as well as answer some questions about its characteristics either on a daily or weekly basis. A healthcare provider and the app's AI algorithm will observe this information to determine the risk of infection. Participants in the control group will not be asked to use the app. Their medical record will be monitored by study staff intermittently to see if they develop infection. This study will take approximately 16 weeks.

Вмешательства

  • Устройство MyHealthPal App
    MyHealthPal (MHP) is a digital platform for postoperative patients to analyze surgical wound characteristics remotely through photos and additional patient data to provide physicians with SSI risk predictions and inform clinical decision making. It allows postoperative patients to capture and upload wound photos and enter surgery-related medication intake (antibiotics, painkillers), vital signs, wound inputs, and well-being patient data. Patients and providers can access the mobile applications

Первичные конечные точки

  • Imageability [Срок оценки: From enrollment to end of app usage at 16 weeks post-surgery]
  • Positive/negative percent agreement [Срок оценки: From enrollment to end of app usage at 16 weeks post-surgery]
  • Patient Usage/Data Entry [Срок оценки: From enrollment to end of app usage at 16 weeks post-surgery]
  • Clinician Feedback [Срок оценки: From first enrollment to final subject's end of app usage at 16 weeks]
  • Safety Risk [Срок оценки: From first enrollment to final subject's end of app usage at 16 weeks]
  • Patient Satisfaction (6-Week Point) [Срок оценки: From enrollment of first subject to 6 weeks post-operation of last subject]
Вторичные конечные точки (8)
  • Specificity [Срок оценки: From first enrollment to final subject's end of app usage at 16 weeks]
  • Sensitivity [Срок оценки: From first enrollment to final subject's end of app usage at 16 weeks]
  • Surgical Site Infection (SSI) Rate [Срок оценки: From first enrollment to final subject's end of app usage at 16 weeks]
  • Surgical Site Infection (SSI) Related Complications [Срок оценки: From first enrollment to final subject's end of app usage at 16 weeks]
  • Surgical Site Infection (SSI) Mortality Rate [Срок оценки: From first enrollment to final subject's end of app usage at 16 weeks]
  • Infection-Related Emergency Department Visits [Срок оценки: From first enrollment to final subject's end of app usage at 16 weeks]
  • Infection-Related Hospital Readmissions [Срок оценки: From first enrollment to final subject's end of app usage at 16 weeks]
  • Patient Satisfaction (16-Week Point) [Срок оценки: From first enrollment to final subject's end of app usage at 16 weeks]

Критерии участия

Критерии включения

  • Adults (18 years old and older).
  • Ability to understand consent process and questionnaires. Patients with ready access to a smartphone, compatible smart device (operating system 5.0 version, also known as Lollipop, for Android and 13 or later version for iOS), smartphone aptitude, smartphone with sufficient memory space for the relevant app, and willingness to participate in the study as assessed by a questionnaire.
  • Patients undergoing one of the following surgeries within the Brigham and Women's Pain Management Practice:
  • Spinal cord stimulator implantation
  • Spinal cord stimulator explant
  • Spinal cord stimulator revision
  • Intrathecal pump implantation
  • Intrathecal pump explant
  • Intrathecal pump revision
  • Ability to attend all standard surgery follow-up appointments at Brigham and Women's Hospital.
  • Ability to understand and sign written informed consent documents.

Критерии исключения

  • Cognitive or physical impairment that would prevent patient from entering data in MHP.
  • Any acute or chronic condition that would limit the ability of the patient to participate in the study.
  • Any patient who is experiencing an ongoing infection prior to undergoing a surgical revision/explant

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
Другое

Центры проведения

США · 1 центр
  • Brigham and Women's Pain Management Center - 850 Boylston St — Chestnut Hill

Идентификаторы

NCT: NCT07391735 · 2025P003153

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗