Comparing 4 approaches for breast reconstruction
Official title: BREAST ADM Trial for Alloplastic Breast Reconstruction
The BREAST Trial: A Randomized, Non-inferiority, Study Comparing the Complication Profile of Four Commercially Available Acellular Dermal Matrixes Used in Alloplastic Breast Reconstruction
Interventions
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.
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.
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.
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.
Canadian Sites (4)
Mount Saint Joseph's Hospital
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
UBC Hospital
Vancouver, British Columbia, Canada
Saint Paul's Hospital
Vancouver, British Columbia, Canada
Eligibility Criteria
See who this study is looking for11 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
- −Patients with an allergy to Polysporin or any of its ingredients.
- −DermACELL: Allergy to Gentamicin, Vancomycin\[12\]
- −Patients undergoing autologous reconstruction either at the time of mastectomy or in a delayed fashion.
- −Patients with a history of previous breast reconstruction procedures.
- −Any patient with a contraindication to breast reconstruction
- −Patients undergoing an axillary node dissection with clearance
- −Patients with contraindications to any of the acellular dermal matrices:
- −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.
- −Patients with prior radiation treatment to the breast or with prior mantle radiation
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: AlloDerm, AlloMax, DermACELL, Flex HD.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 4 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 21 years to 65 years.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 328 people.
The study is currently expected to finish around December 2025.
The main measurement is taken over: Within 6 months of stage I or stage II surgery.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Seroma incidence — measured over Within 6 months of stage I or stage II surgery.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04661501 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About AlloDermDevice
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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About AlloMaxDevice
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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About DermACELLDevice
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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About Flex HDDevice
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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 21 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 21 years to 65 years.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Within 6 months of stage I or stage II surgery.
The study as a whole is currently expected to finish around 2025-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 328 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Vancouver, British Columbia, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.