Breast ReconstructionNCT03145337
Reconstruction Outcomes in Immediate Post-mastectomy Breast Reconstruction With ADM
A study testing FlexHD ADM (Cohort A) and AlloDerm RTU ADM (Cohort B) in people with Breast Reconstruction, run by Musculoskeletal Transplant Foundation at 7 sites in United States.
Trial summary
Evaluation and comparison of clinical and aesthetic outcomes associated with the use of two allograft dermal matrices (ADMs) currently in use for tissue assisted immediate post-mastectomy breast reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- FlexHD ADM (Cohort A) and AlloDerm RTU ADM (Cohort B)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Jul 2017to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo immediate, post-mastectomy, tissue assisted breast reconstruction, Reconstruction shall be either one-stage (direct-to-implant) or two-stage, unilateral or bilateral, prophylactic or therapeutic
- Females at least 18 years of age
- Non-smokers, former smokers and/or smokers who have not smoked within 1 month before surgery, and who agree to not smoke or utilize e-cigarettes during the post-operative period
- Have signed a written informed consent
- Have the ability to understand and comply with the requirements and follow-up time points of the study
Who cannot join
- Previous breast surgery with the exception of biopsy
- Previous radiation treatment in either breast at any time
- Undergoing autologous breast reconstruction
- Pre-pectoral implant placement
- Undergoing delayed reconstruction
- Requiring Wise pattern reduction of mastectomy skin flap
Show all 11Show fewer
- History of chronic steroid use within the past 6 months
- History of HIV positive
- Previous organ transplant
- Pregnant or lactating females
- Clinically significant systemic disease, as determined by the investigator, which could affect study participation or study results
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University Medical Center
Chicago, Illinois, 60611
NorthShore Health Systems
Evanston, Illinois, 60062
Harris Methodist Southlake Hospital
Fort Worth, Texas, 76104
Faulkner Brigham & Women's Hospital
Jamaica Plain, Massachusetts, 02130
Louisiana State Health Science Center
New Orleans, Louisiana, 70115
New York University Langone Medical Center
New York, New York, 10017
About this study
Official title: A Prospective, Randomized, Multi-Center Clinical Study Comparing Outcomes in Patients Undergoing Prosthetic, Acellular Dermal Matrix (ADM) Assisted, Immediate Post-Mastectomy Breast Reconstruction
Evaluation and comparison of clinical and aesthetic outcomes associated with the use of two allograft dermal matrices (ADMs) currently in use for tissue assisted immediate post-mastectomy breast reconstruction.
Read the detailed description
This is a level one, prospective, randomized, controlled multi-center clinical study comparing two types of acellular dermal matrices (ADMs) currently used in immediate post-mastectomy prosthetic breast reconstruction. Comparison of these two ADMs will be made in the areas of reconstructive clinical outcomes and aesthetic outcomes. Patients will be randomized into one of two ADM groups as part of their immediate post-mastectomy breast reconstruction. Patients in both groups will be followed for twelve months after their reconstructive surgery. Clinical outcomes will be documented at 1 month, 3 months, 6 months and 12 months following breast reconstructive surgery. For one-stage breast reconstruction, aesthetic outcomes will be assessed and documented at 6 and 12 months following implant placement. For two-stage reconstruction, patients will be evaluated for aesthetic outcomes at a time point 6-12 months following expander-to-implant exchange if it does not coincide with the 12 month post-mastectomy visit.
- Conditions
- Breast Reconstruction
- Being tested
- FlexHD ADM (Cohort A), AlloDerm RTU ADM (Cohort B)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlexHD ADM (Cohort A)Biological
Also called FlexHD ADM
Tissue assisted breast reconstruction with FlexHD pliable perforated ADM
AlloDerm RTU ADM (Cohort B)Biological
Also called AlloDerm RTU ADM
Tissue assisted breast reconstruction with AlloDerm RTU perforated ADM
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Active comparator | FlexHD ADM Receives: Biological: FlexHD ADM (Cohort A) |
| Cohort B | Active comparator | AlloDerm RTU ADM Receives: Biological: AlloDerm RTU ADM (Cohort B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Reconstruction Complication Rates
To compare the overall complication rate between the cohorts defined as either 1) post-operative infection specific to the reconstructed breast(s) requiring either intravenous antibiotic treatment or operative intervention, 2) seroma, and/or 3) reconstructive failure
Measured: 12 months
Secondary outcomes (2)
Comparison of Each Complication Rate
To compare each complication rate between the cohorts defined as 1) post-operative infection specific to the reconstructed breast(s) requiring either intravenous antibiotic treatment or operative intervention 20 seroma 3) reconstructive failure and 4) reoperation for reasons other than infection
Measured: 12 months
Comparison of Aesthetic Outcomes (Photographs)
A blinded comparison of aesthetic outcomes (photographs) using pre-defined criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 Jul 2017
- Primary completionFeb 2019 (estimated)
- Study completionMay 2019 (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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Musculoskeletal Transplant Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145337
- Sponsor's protocol ID
- MTF 16-04-01
- Status last verified
- May 2018
- First submitted
- 3 May 2017
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-Center Clinical Study Comparing Outcomes in Patients Undergoing Prosthetic, Acellular Dermal Matrix (ADM) Assisted, Immediate Post-Mastectomy Breast Reconstruction
- ClinicalTrials.gov ID
- NCT03145337
- Acronym / sponsor ID
- MTF 16-04-01
- Conditions
- Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Musculoskeletal Transplant FoundationUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 9 May 2017 (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.
Evaluation and comparison of clinical and aesthetic outcomes associated with the use of two allograft dermal matrices (ADMs) currently in use for tissue assisted immediate post-mastectomy breast reconstruction.
Detailed description
This is a level one, prospective, randomized, controlled multi-center clinical study comparing two types of acellular dermal matrices (ADMs) currently used in immediate post-mastectomy prosthetic breast reconstruction. Comparison of these two ADMs will be made in the areas of reconstructive clinical outcomes and aesthetic outcomes. Patients will be randomized into one of two ADM groups as part of their immediate post-mastectomy breast reconstruction. Patients in both groups will be followed for twelve months after their reconstructive surgery. Clinical outcomes will be documented at 1 month, 3 months, 6 months and 12 months following breast reconstructive surgery. For one-stage breast reconstruction, aesthetic outcomes will be assessed and documented at 6 and 12 months following implant placement. For two-stage reconstruction, patients will be evaluated for aesthetic outcomes at a time point 6-12 months following expander-to-implant exchange if it does not coincide with the 12 month post-mastectomy visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Active comparator | Biological: FlexHD ADM (Cohort A)FlexHD ADM |
| Cohort B | Active comparator | Biological: AlloDerm RTU ADM (Cohort B)AlloDerm RTU ADM |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Scheduled to undergo immediate, post-mastectomy, tissue assisted breast reconstruction, Reconstruction shall be either one-stage (direct-to-implant) or two-stage, unilateral or bilateral, prophylactic or therapeutic
- Females at least 18 years of age
- Non-smokers, former smokers and/or smokers who have not smoked within 1 month before surgery, and who agree to not smoke or utilize e-cigarettes during the post-operative period
- Have signed a written informed consent
- Have the ability to understand and comply with the requirements and follow-up time points of the study
Key exclusion criteria (11 listed)
- Previous breast surgery with the exception of biopsy
- Previous radiation treatment in either breast at any time
- Undergoing autologous breast reconstruction
- Pre-pectoral implant placement
- Undergoing delayed reconstruction
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 |
|---|---|---|
| FlexHD ADM (Cohort A)Also: FlexHD ADMTissue assisted breast reconstruction with FlexHD pliable perforated ADM | Biological | Cohort A |
| AlloDerm RTU ADM (Cohort B)Also: AlloDerm RTU ADMTissue assisted breast reconstruction with AlloDerm RTU perforated ADM | Biological | Cohort B |
Primary outcome
Post Reconstruction Complication Rates
Time frame: 12 months
To compare the overall complication rate between the cohorts defined as either 1) post-operative infection specific to the reconstructed breast(s) requiring either intravenous antibiotic treatment or operative intervention, 2) seroma, and/or 3) reconstructive failure
2 secondary outcomes
Comparison of Each Complication Rate
Time frame: 12 months
Comparison of Aesthetic Outcomes (Photographs)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlexHD ADM (Cohort A) and AlloDerm RTU ADM (Cohort B) in people with Breast Reconstruction, run by Musculoskeletal Transplant Foundation at 7 sites in United States.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Reconstruction Complication Rates (time frame: 12 months). 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 19 Sep 2018.