BREAST ADM Trial for Alloplastic Breast Reconstruction

Официальное название

The BREAST Trial: A Randomized, Non-inferiority, Study Comparing the Complication Profile of Four Commercially Available Acellular Dermal Matrixes Used in Alloplastic Breast Reconstruction

Обзор

This study is a randomized single blinded prospective clinical trial comparing the surgical outcomes of four different acellular dermal matrixes (ADMs) after primary breast reconstruction. ADMs are used in conjunction with tissue expanders or breast implants to reinforce the recreated breast pocket. Currently, 4 different ADMS are commercially available: AlloDerm, DermaCell, Allomax and Flex HD. It is unclear which ADM is clinically superior. The objective of the study is to compare the complications and post-op care of 4 different ADMs within a 2 year follow up to elucidate their surgical outcomes.

Подробное описание

This study is a randomized control trial and will include all patients who are agreeable and deemed appropriate for alloplastic breast reconstruction involving the use of an ADM with two stage tissue expander (TE) reconstruction. The ADMs used will be determined by random assignment to one of four available products being utilized within the study: AlloDerm, AlloMax, DermACELL and FlexHD. Each ADM product will comprise of an individual treatment arm. Participants undergoing bilateral reconstruction will have the same ADM used in each side. The four treatment arms will be compared to assess their impact on our primary outcome: proportion of clinically significant post-operative seroma requiring intervention. Analysis will be performed per surgeon to prevent post-operative outcomes from being confounded by the principle operator. The trial will initially be conducted as an internal pilot study. The study will initially target a study population of 40 patients for recruitment as a means to assess the feasibility of the study. In doing this, the pilot study will be able to establish the necessary protocol and administrative infrastructure that is needed to complete the trial in its entirety. This create a sample population for initial outcomes.

Вмешательства

• Устройство AlloDerm
  Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.
• Устройство AlloMax
  Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.
• Устройство DermACELL
  Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.
• Устройство Flex HD
  Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.

Первичные конечные точки

• Seroma incidence [Срок оценки: Within 6 months of stage I or stage II surgery]

Вторичные конечные точки (12)

• Mean drain duration (Days) [Срок оценки: Within 1 month of stage I or stage II surgery]
• Mean drain output (ml) [Срок оценки: Within 1 month of stage I or stage II surgery]
• Mean seroma volume (ml) [Срок оценки: Within 6 months of stage I or stage II surgery]
• Mean aspirations per seroma [Срок оценки: Within 6 months of stage I or stage II surgery]
• Hematoma incidence [Срок оценки: Within 1 month of stage I or stage II surgery]
• Surgical site infection incidence [Срок оценки: Within 6 months of stage I or stage II surgery]
• Number of Participants with Implant loss [Срок оценки: Within 2 year of stage II surgery]
• Number of Participants with Red breast syndrome [Срок оценки: Within 1 month of stage I surgery]
• Number of Participants with Unplanned surgical care [Срок оценки: Within 2 year of stage I or stage II surgery]
• Number of Participants with Mastectomy flap necrosis [Срок оценки: Within 1 month of stage I surgery]
• Capsular contracture incidence [Срок оценки: Within 1 year of stage II surgery]
• ADM integration assessment [Срок оценки: Within 1 month of stage II procedure]

Критерии участия

Критерии включения

• All woman aged 21 years or older but less that 65 undergoing unilateral or bilateral mastectomy with alloplastic breast reconstruction using ADM.
• Breast reconstruction must be done by means of a two staged process using tissue expanders and ADM based reconstruction followed by implant tissue expander to implant exchange.

Критерии исключения

• Patients undergoing autologous reconstruction either at the time of mastectomy or in a delayed fashion.
• Patients with a history of previous breast reconstruction procedures.
• Patients with prior radiation treatment to the breast or with prior mantle radiation
• Any patient with a contraindication to breast reconstruction
• Patients undergoing an axillary node dissection with clearance
• Patients with an allergy to Polysporin or any of its ingredients.
• Patients with contraindications to any of the acellular dermal matrices:

• DermACELL: Allergy to Gentamicin, Vancomycin\[12\]
• The surgeon performing the breast reconstruction may also deem a patient ineligible if intraoperatively, there is evidence of significant mastectomy flap ischemia prior to the initiation of the breast reconstruction procedure.

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

Простое слепое

Основная цель

Другое

Центры проведения

Канада · 4 центра

• Mount Saint Joseph's Hospital — Vancouver
• Vancouver General Hospital — Vancouver
• UBC Hospital — Vancouver
• Saint Paul's Hospital — Vancouver

Идентификаторы

NCT: NCT04661501 · H18-02052

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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