BREAST ADM Trial for Alloplastic Breast Reconstruction

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.

• AlloDerm (Device): 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.
• AlloMax (Device): 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.
• DermACELL (Device): 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.
• Flex HD (Device): 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.

Primary outcomes

• Seroma incidence [Within 6 months of stage I or stage II surgery]: Incidence of seroma formation requiring intervention including aspiration in-office or ultrasound-guided drainage

Secondary outcomes

• Mean drain duration (Days) [Within 1 month of stage I or stage II surgery]: Postoperative duration of drain placements
• Mean drain output (ml) [Within 1 month of stage I or stage II surgery]: Total volume of drain output until drain removal
• Mean seroma volume (ml) [Within 6 months of stage I or stage II surgery]: Total volume of seroma fluid aspirated until resolution of seroma
• Mean aspirations per seroma [Within 6 months of stage I or stage II surgery]: Number of aspirations required for seroma resolution
• Hematoma incidence [Within 1 month of stage I or stage II surgery]: Incidence of hematoma requiring evacuation or aspiration
• Surgical site infection incidence [Within 6 months of stage I or stage II surgery]: Incidence of surgical site infection requiring antibiotics or operative management
• Number of Participants with Implant loss [Within 2 year of stage II surgery]: Loss of Implant for any reason (wound dehiscence, exposure, periprosthetic infection)
• Number of Participants with Red breast syndrome [Within 1 month of stage I surgery]: Noninfectious erythema localized to the area of ADM reconstruction
• Number of Participants with Unplanned surgical care [Within 2 year of stage I or stage II surgery]: Unexpected return to the operating room that was not planned at the initial visit for any reason
• Number of Participants with Mastectomy flap necrosis [Within 1 month of stage I surgery]: Mastectomy flap necrosis and associated management: expectant, office debridement, or return to the operating room
• Capsular contracture incidence [Within 1 year of stage II surgery]: Incidence of capsular contracture (as identified by the plastic surgeon, grouped by Baker's classification of severity)
• ADM integration assessment [Within 1 month of stage II procedure]: Clinical assessment of ADM integration into the breast pocket at the time of the second stage procedure.
• Post-operative aesthetic assessment (patient and surgeon) [Within 2 years of stage II surgery]: Subjective assessment of cosmetic outcome by the patient and blinded assessors using post-operative aesthetic breast survey assessment
• Pre and post-operative satisfaction assessed using BREAST-Q [Within 2 years of stage II surgery]: Evaluation of the satisfaction and quality of life of patients undergoing breast surgery using the BREAST-Q. Breast-Q is based on Breast Cancer Core Scale ranging from 0 to 100. Higher score means better outcome.

Sex: Female, ages: 21 Years to 65 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

• Study Protocol and Statistical Analysis Plan (PDF, 2020-04-29)
• Informed Consent Form (PDF, 2020-05-19)

• Dr. Nancy Van Laeken, Principal investigator, University of British Columbia