Breast ReconstructionBreast_ADMNCT04661501
BREAST ADM Trial for Alloplastic Breast Reconstruction
A study testing AlloDerm, AlloMax and DermACELL in people with Breast Reconstruction, run by University of British Columbia at 4 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- AlloDerm, AlloMax and DermACELL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 4 sitesCanada
- Study dates
- 25 Nov 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Raveena Gowda contact
Canada4 sites, 4 recruiting
- Recruiting
Mount Saint Joseph's Hospital
Vancouver, British Columbia, V5T 3N4
Dr. Nancy Van Laeken, MD, FRCSC, 604-669-1633 ext. 5, Nancy@vanlaeken.com
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Dr. Peter Lennox, MD, FRCSC, 604-876-6552, peter.lennox@ubc.ca
- Recruiting
UBC Hospital
Vancouver, British Columbia, V6T 1Z7
Dr. Sheina Macadam, MD, FRCSC, 604-876-1688, drsmacadam@drsheinamacadam.com
- Recruiting
Saint Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Dr. Kathryn Isaac, MD, FRCSC, 604-336-8488, kathryn.isaac@ubc.ca
About this study
Official title: The BREAST Trial: A Randomized, Non-inferiority, Study Comparing the Complication Profile of Four Commercially Available Acellular Dermal Matrixes Used in Alloplastic Breast Reconstruction
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.
Read the detailed description
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.
- Conditions
- Breast Reconstruction
- Being tested
- AlloDerm, AlloMax, DermACELL, Flex HD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| AlloDerm group | Active comparator | Device for immediate implant based breast reconstruction. Receives: Device: AlloDerm |
| AlloMax group | Active comparator | Device for immediate implant based breast reconstruction. Receives: Device: AlloMax |
| DermACELL group | Active comparator | Device for immediate implant based breast reconstruction. Receives: Device: DermACELL |
| Flex HD group | Active comparator | Device for immediate implant based breast reconstruction. Receives: Device: Flex HD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroma incidence
Incidence of seroma formation requiring intervention including aspiration in-office or ultrasound-guided drainage
Measured: Within 6 months of stage I or stage II surgery
Secondary outcomes (14)
Mean drain duration (Days)
Postoperative duration of drain placements
Measured: Within 1 month of stage I or stage II surgery
Mean drain output (ml)
Total volume of drain output until drain removal
Measured: Within 1 month of stage I or stage II surgery
Mean seroma volume (ml)
Total volume of seroma fluid aspirated until resolution of seroma
Measured: Within 6 months of stage I or stage II surgery
Mean aspirations per seroma
Number of aspirations required for seroma resolution
Measured: Within 6 months of stage I or stage II surgery
Hematoma incidence
Incidence of hematoma requiring evacuation or aspiration
Measured: Within 1 month of stage I or stage II surgery
Surgical site infection incidence
Incidence of surgical site infection requiring antibiotics or operative management
Measured: 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)
Measured: Within 2 year of stage II surgery
Number of Participants with Red breast syndrome
Noninfectious erythema localized to the area of ADM reconstruction
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: Within 2 years of stage II surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start25 Nov 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Van Laeken, University of British Columbia
- Investigators
- Dr. Nancy Van Laeken, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661501
- Sponsor's protocol ID
- H18-02052
- Acronym
- Breast_ADM
- Status last verified
- Dec 2024
- First submitted
- 23 Oct 2020
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BREAST Trial: A Randomized, Non-inferiority, Study Comparing the Complication Profile of Four Commercially Available Acellular Dermal Matrixes Used in Alloplastic Breast Reconstruction
- ClinicalTrials.gov ID
- NCT04661501
- Acronym / sponsor ID
- Breast_ADM / H18-02052
- Conditions
- Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AlloDerm group | Active comparator | Device: AlloDermDevice for immediate implant based breast reconstruction. |
| AlloMax group | Active comparator | Device: AlloMaxDevice for immediate implant based breast reconstruction. |
| DermACELL group | Active comparator | Device: DermACELLDevice for immediate implant based breast reconstruction. |
| Flex HD group | Active comparator | Device: Flex HDDevice for immediate implant based breast reconstruction. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlloDermAcellular 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. | Device | AlloDerm group |
| AlloMaxAcellular 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. | Device | AlloMax group |
| DermACELLAcellular 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. | Device | DermACELL group |
| Flex HDAcellular 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. | Device | Flex HD group |
Primary outcome
Seroma incidence
Time frame: Within 6 months of stage I or stage II surgery
Incidence of seroma formation requiring intervention including aspiration in-office or ultrasound-guided drainage
14 secondary outcomes
Mean drain duration (Days)
Time frame: Within 1 month of stage I or stage II surgery
Mean drain output (ml)
Time frame: Within 1 month of stage I or stage II surgery
Mean seroma volume (ml)
Time frame: Within 6 months of stage I or stage II surgery
Mean aspirations per seroma
Time frame: Within 6 months of stage I or stage II surgery
Hematoma incidence
Time frame: Within 1 month of stage I or stage II surgery
Surgical site infection incidence
Time frame: Within 6 months of stage I or stage II surgery
Number of Participants with Implant loss
Time frame: Within 2 year of stage II surgery
Number of Participants with Red breast syndrome
Time frame: Within 1 month of stage I surgery
Number of Participants with Unplanned surgical care
Time frame: Within 2 year of stage I or stage II surgery
Number of Participants with Mastectomy flap necrosis
Time frame: Within 1 month of stage I surgery
Capsular contracture incidence
Time frame: Within 1 year of stage II surgery
ADM integration assessment
Time frame: Within 1 month of stage II procedure
Post-operative aesthetic assessment (patient and surgeon)
Time frame: Within 2 years of stage II surgery
Pre and post-operative satisfaction assessed using BREAST-Q
Time frame: Within 2 years of stage II surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raveena Gowda contact
Dr. Nancy Van Laeken principal investigator
University of British Columbia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AlloDerm, AlloMax and DermACELL in people with Breast Reconstruction, run by University of British Columbia at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Nancy Van Laeken (604-669-1633, nancy@vanlaeken.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroma incidence (time frame: Within 6 months of stage I or stage II surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.