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Идёт набор NCT07147166

Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy

Без фазы С лечением Gender Dysphoria Mastectomy Hypertrophic Scar

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: Brijjit® BP100-6 and BP-75, Control: Standard of care and normal wound dressing.
Кому может быть актуально
Состояния в реестре: Gender Dysphoria, Mastectomy, Hypertrophic Scar. Базовые параметры: от 19 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

Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy: A Randomized Self-Controlled Trial

Обзор

The goal of this randomized, prospective, interventional clinical trial is to evaluate the use of Brijjit® in reducing the incidence of hypertrophic scarring in individuals undergoing gender-affirming bilateral double incision mastectomies at a single-institution, single-surgeon site (Esther A. Kim, MD). Patients will serve as a self-control (one side of the chest receives intervention, the other serves as a control). Primary endpoints include scar appearance and quality. Secondary endpoints include patient perception of the scar using the Patient and Observer Scar Assessment Scale (POSAS). Participants will be taught how to apply Brijjit® at home if any units fall off before 6 weeks postop.

Подробное описание

The hypothesis of this study is that the use of Brijjit® Force-Modulating Tissue Bridge devices will reduce the incidence of hypertrophic scarring as measured by objective and subjective factors compared to no intervention following gender-affirming double incision mastectomy. Patients will serve as self-controls (one side of the chest will receive the intervention, the other will not). Consistent use of silicone-based tape, the current gold standard for wound care, will be encouraged on the control side of the chest.

We hypothesize that applying FMTBs to surgical incisions will improve scar outcomes by limiting pro-fibrotic signaling and promoting optimal wound healing. Should our hypotheses be proven, this study will provide a compelling reason to implement Brijjit therapy into standard clinical practice as a non-invasive preventative measure to improve scar outcomes.

Вмешательства

  • Устройство Brijjit® BP100-6 and BP-75
    Brijjit® BP-100 and BP-75 are a non-invasive, flexible devices that acts as a force modulating tissue bridge (FMTB) to aid in wound healing. BP-100 and BP-75 simply refer to different sizes of the Brijjit device.
  • Другое Control: Standard of care and normal wound dressing
    The control chest side will receive only standard of care and normal wound dressing.

Первичные конечные точки

  • Presence of Hypertrophic Scarring [Срок оценки: 6 weeks postop]
  • Presence of Hypertrophic Scarring [Срок оценки: 3 months postop]
  • Presence of Hypertrophic Scarring [Срок оценки: 6 months postop]
  • Presence of Hypertrophic Scarring [Срок оценки: 1 year postop]
  • Scar Characteristics [Срок оценки: 6 weeks postop]
  • Scar characteristics [Срок оценки: 3 months postop]
  • Scar Characteristics [Срок оценки: 6 months postop]
  • Scar Characteristics [Срок оценки: 1 year postop]
  • Scar Dimensions [Срок оценки: 6 weeks postop]
  • Scar Dimensions [Срок оценки: 3 months postop]
Вторичные конечные точки (4)
  • Patient Perception of Scar [Срок оценки: 6 weeks postop]
  • Patient Perception of Scar [Срок оценки: 3 months postop]
  • Patient Perception of Scar [Срок оценки: 6 months postop]
  • Patient Perception of Scar [Срок оценки: 1 year postop]

Критерии участия

Критерии включения

  • Age ≥ 19
  • Undergoing double incision gender affirming mastectomy
  • Ability to adhere to Brijjit therapy after surgery
  • Willing to return for follow-up visits and undergo study evaluations

Критерии исключения

  • History of keloid formation
  • Radiation therapy history
  • Prior surgeries of the chest or breast
  • History or use following prescription medications: 1) accutane within the past year. 2) chronic systemic steroids
  • Active smoker
  • Disorder known to negatively affect wound healing (autoimmune, connective tissue, uncontrolled diabetes)
  • Any other condition determined by PI to preclude subject from joining study

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • UCSF Department of Plastic & Reconstructive Surgery — San Francisco

Публикации

  • Panton J, Vingan N, Barillas J, Akgul Y, Lazzarini A, Coroneos CJ, Amirlak B, Kenkel J, Culver A. Postoperative Mechanomodulation Decreases T-Junction Dehiscence After Reduction Mammaplasty: Early Scar Analysis From a Randomized Controlled Trial. Aesthet Surg J. 2023 Nov 16;43(12):NP1033-NP1048. doi: 10.1093/asj/sjad269. PMID 37606245
  • Cao G, Ye M, Wang H, Liu Y, Li M. The Role of Biomechanical Forces in the Formation and Treatment of Pathological Scars. Clin Cosmet Investig Dermatol. 2024 Nov 13;17:2565-2571. doi: 10.2147/CCID.S496253. eCollection 2024. PMID 39559183

Идентификаторы

NCT: NCT07147166 · 24-43094

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗