BREAST ADM Trial for Alloplastic Breast Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Reconstruction

Intervention / Treatment
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* Device: AlloDerm
* Device: AlloMax
* Device: DermACELL
* Device: Flex HD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AlloDerm group<br>Device for immediate implant based breast reconstruction. | Device: AlloDerm<br>* 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.<br>|
| Active Comparator: AlloMax group<br>Device for immediate implant based breast reconstruction. | Device: AlloMax<br>* 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.<br>|
| Active Comparator: DermACELL group<br>Device for immediate implant based breast reconstruction. | Device: DermACELL<br>* 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.<br>|
| Active Comparator: Flex HD group<br>Device for immediate implant based breast reconstruction. | Device: Flex HD<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroma incidence | Incidence of seroma formation requiring intervention including aspiration in-office or ultrasound-guided drainage | Within 6 months of stage I or stage II surgery | 

Secondary Outcome Measures

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