MastectomyNCT02263261
Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction
A study testing Flex HD Pliable Perforated HADM in people with Mastectomy and Breast Reconstruction, run by Musculoskeletal Transplant Foundation at 2 sites in United States.
Trial summary
Use of a HADM and implant in 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
- Mastectomy, Breast Reconstruction
- What is being tested?
- Flex HD Pliable Perforated HADM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2015to Nov 2016
- 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 a single or two-stage, tissue-assisted, implant breast reconstruction
- Mastectomy may be unilateral or bilateral, prophylactic or therapeutic
- Skin incision may be skin sparing, or nipple-areolar sparing
- Have signed written, informed consent
- Be at least 18 years of age
Who cannot join
- Patients undergoing autologous breast reconstruction
- Patients undergoing breast reconstruction following complications of breast augmentation, mastopexy, breast reduction, or breast conservation surgery (lumpectomy)
- Patients undergoing reconstruction after previously failed attempts at reconstruction
- Patients undergoing autologous breast reconstruction in conjunction with a tissue expander (such as a latissimus dorsi flap, DIEP flap)
- There will be no exclusions based on race or ethnicity
- BMI > 40
- Previous Radiation Treatment. Note: Post-operative radiation treatment does not exclude subjects from study continuation once enrolled.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Liu Plastic surgery
Mountain View, California, 94040
Liu Plastic Surgery
San Jose, California, 95124
About this study
Official title: Reconstructive, Aesthetic and Patient Reported Outcomes Associated With the Use of Flex HD Pliable, Perforated Human Acellular Dermal Matrix in Implant-Based Breast Reconstruction: A Pilot Study
Use of a HADM and implant in post-mastectomy breast reconstruction.
Read the detailed description
This is a prospective, single-site pilot study in which outcomes associated with the use of Flex HD® Pliable™ Perforated, Human Acellular Dermal Matrix and an implant which are used in post-mastectomy breast reconstruction will be obtained. The data collected will include reconstructive outcomes, aesthetic outcomes and patient-reported outcomes in order to ascertain advantages and disadvantages of using this particular HADM in post-mastectomy breast reconstruction.
- Conditions
- Mastectomy, Breast Reconstruction
- Being tested
- Flex HD Pliable Perforated HADM
- Keywords
- dermal matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flex HD Pliable Perforated HADMOther
Human Acellular Dermal Matrix
| Study group | Role | What they receive |
|---|---|---|
| Flex HD Pliable Perforated HADM | Other | Single Arm Receives: Other: Flex HD Pliable Perforated HADM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Types and incidence of complications
Documentaiton of any medical and/or surgical problem requiring treatment that arises as a result of the reconstruction procedure
Measured: 6 months post reconstruction
Secondary outcomes (2)
Aesthetic Outcomes
Aesthetic outcomes evaluated by the operating surgeon and two independent board certified plastic surgeons with breast reconstruction expertise
Measured: 6 months post reconstruction
Patient-Reported Outcomes
Use of the Breast Q survey instrument
Measured: 6 months post reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Musculoskeletal Transplant Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263261
- Sponsor's protocol ID
- MTF 13-03
- Status last verified
- Mar 2015
- First submitted
- 6 Oct 2014
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstructive, Aesthetic and Patient Reported Outcomes Associated With the Use of Flex HD Pliable, Perforated Human Acellular Dermal Matrix in Implant-Based Breast Reconstruction: A Pilot Study
- ClinicalTrials.gov ID
- NCT02263261
- Acronym / sponsor ID
- MTF 13-03
- Conditions
- Mastectomy, Breast Reconstruction
- Keywords
- dermal matrix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Musculoskeletal Transplant FoundationUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 13 Oct 2014 (estimated)
- 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.
Use of a HADM and implant in post-mastectomy breast reconstruction.
Detailed description
This is a prospective, single-site pilot study in which outcomes associated with the use of Flex HD® Pliable™ Perforated, Human Acellular Dermal Matrix and an implant which are used in post-mastectomy breast reconstruction will be obtained. The data collected will include reconstructive outcomes, aesthetic outcomes and patient-reported outcomes in order to ascertain advantages and disadvantages of using this particular HADM in post-mastectomy breast reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flex HD Pliable Perforated HADM | Other | Other: Flex HD Pliable Perforated HADMSingle Arm |
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 a single or two-stage, tissue-assisted, implant breast reconstruction
- Mastectomy may be unilateral or bilateral, prophylactic or therapeutic
- Skin incision may be skin sparing, or nipple-areolar sparing
- Have signed written, informed consent
- Be at least 18 years of age
Key exclusion criteria (7 listed)
- Patients undergoing autologous breast reconstruction
- Patients undergoing breast reconstruction following complications of breast augmentation, mastopexy, breast reduction, or breast conservation surgery (lumpectomy)
- Patients undergoing reconstruction after previously failed attempts at reconstruction
- Patients undergoing autologous breast reconstruction in conjunction with a tissue expander (such as a latissimus dorsi flap, DIEP flap)
- There will be no exclusions based on race or ethnicity
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 |
|---|---|---|
| Flex HD Pliable Perforated HADMHuman Acellular Dermal Matrix | Other | Flex HD Pliable Perforated HADM |
Primary outcome
Types and incidence of complications
Time frame: 6 months post reconstruction
Documentaiton of any medical and/or surgical problem requiring treatment that arises as a result of the reconstruction procedure
2 secondary outcomes
Aesthetic Outcomes
Time frame: 6 months post reconstruction
Patient-Reported Outcomes
Time frame: 6 months post reconstruction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flex HD Pliable Perforated HADM in people with Mastectomy and Breast Reconstruction, run by Musculoskeletal Transplant Foundation at 2 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 7 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: finished, as of the sponsor's last update on 20 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 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Types and incidence of complications (time frame: 6 months post reconstruction). 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 20 Sep 2018.