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Идёт набор NCT05243966

Myriad™ Augmented Soft Tissue Reconstruction Registry

Наблюдательное Abdominal Wound Dehiscence Necrotizing Soft Tissue Infection Lower Extremity Wound Pilonidal Sinus

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: Myriad Matrix™ and Myriad Morcells™.
Кому может быть актуально
Состояния в реестре: Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection, Lower Extremity Wound, Pilonidal Sinus. 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 →
Официальное название

Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures

Обзор

This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriad™ as part of the surgical intervention.

Подробное описание

This is an observational, multi-center, single arm, Phase IV study, designed to evaluate the safety and clinical outcomes of Matrix and Morcells in soft tissue reconstruction procedures.

The study is a registry study and will enroll participants who are undergoing a surgical procedure, and where the attending physician will use Myriad Matrix™ and/or Morcells™ as part of the surgical intervention.

Participants enrolled in the study will be undergoing a range of surgical procedures involving the reconstruction of soft tissues, including but not limited to:

* Abdominal dehiscence * Necrotizing soft tissue infection (NSTI) * Lower extremity complex non-healing wounds (limb salvage) * Pilonidal sinus disease * Anal fistula * Hidradenitis suppurativa reconstruction * Pressure injury reconstruction

Other procedure types may be included at the discretion of the Investigator/Research Team.

Participants that are being enrolled in the study would otherwise be undergoing their surgical procedure with either of the Myriad™ devices as part of Standard of Care (SoC).

The pre-operative care and preparation of the surgical site (prior to the application of Myriad™ devices) shall be undertaken at the discretion of the attending physician and per their institutional protocols and procedures. Surgical technique for the participants reconstruction is at the discretion of the attending physician. Use of Myriad Matrix™ or Morcells as part of the surgery shall be per the products Instructions for Use. Myriad Matrix™ devices may be implanted or used for dermal regeneration as part of the participants surgical procedure. Myriad Morcells™ may be used for dermal regeneration and in combination with the Myriad Matrix™ devices. The participants post-operative care is at the discretion of the attending physician.

Early and late-stage healing outcomes will be assessed as part of the study and as part of standard of care.

Through the course of treatment and following up care de-identified patient data (quantitative qualitative assessment measures and digital images) will be captured and from the basis of the registry dataset.

Вмешательства

  • Устройство Myriad Matrix™ and Myriad Morcells™
    Ovine forestomach matrix sheet graft and morselized extracellular matrix

Первичные конечные точки

  • Proportion of participants with treatment emergent adverse events during the study [Срок оценки: 3 years]
Вторичные конечные точки (4)
  • Time (weeks) to complete healing [Срок оценки: Up to 52 weeks]
  • Percentage of surgical complications [Срок оценки: Up to 3 months]
  • Time (weeks) to 100% granulation [Срок оценки: Up to 3 months]
  • Percentage of split thickness skin graft take at 1 week post Matrix™ application [Срок оценки: 1 week post application]

Критерии участия

Критерии включения

  • Willing and able to provide written informed consent and to comply with the requirements of Clinical Investigational Plan
  • Male or female patients aged 18 years or above
  • Patients where Matrix and/or Morcells were used as part of their soft tissue reconstruction procedure
  • Subject that are willing and able to comply with all aspects of the treatment and evaluation schedule

Критерии исключения

  • Patients with known sensitivity to ovine (sheep) derived material
  • Patients with full thickness ('third degree') burns
  • Patients with wounds with uncontrolled clinical infection (CDC Contamination Grade=4)
  • Any medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the patient to participate in the study
  • Patient is currently participating or has participated in another clinical study within past 30 days prior to enrollment
  • Pregnant or lactating women
  • Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

США · 15 центров
  • The Diane & Bruce Halle Arizona Burn Center at Valleywise Health — Phoenix
  • Surgery Group LA — Los Angeles
  • Associates in Medicine & Surgery — Fort Myers
  • Asencion Sacred Heart — Pensacola
  • Northeast Georgia Medical Center, Inc. — Gainesville
  • University of IOWA Health Care — Iowa City
  • University Medical Center — New Orleans
  • Ochsner Baptist Medical Center — New Orleans
  • … и ещё 7 центров

Публикации

  • Trinh SM, Andre K, Ozcan AI, Vitharana DS, Deville PE, Mason JW, Hunt JP, Marr AB, Greiffenstein PP, Stuke LE, Smith AA. Surgical management of stage 3 and 4 pressure injuries in trauma patients using ovine forestomach matrix grafts: a prospective case series. Front Surg. 2026 Apr 20;13:1704665. doi: 10.3389/fsurg.2026.1704665. eCollection 2026. PMID 42087918

Идентификаторы

NCT: NCT05243966 · CIP.SUR.001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗