Breast Reconstruction Following MastectomyNCT02775409
Prospective Trial of Subcutaneous Versus Subpectoral 2-Staged Implant-Based Breast Reconstruction
A study testing Subcutaneous placement and Submuscular placement in people with Breast Reconstruction Following Mastectomy, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is for women scheduled to have immediate breast reconstruction following mastectomy using a tissue expander. The primary purpose of this study is to learn whether there are differences in the outcome between placing the tissue expander above the muscle or below the muscle. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction Following Mastectomy
- What is being tested?
- Subcutaneous placement and Submuscular placement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2016to 6 Feb 2020
- 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
- Women at least 18 years of age, who will undergo immediate unilateral or bilateral implant-based breast reconstruction following therapeutic skin-sparing or nipple-sparing mastectomy.
- Women at least 18 years of age, who will undergo immediate bilateral implant-based breast reconstruction following risk-reduction (prophylactic) skin-sparing or nipple-sparing mastectomy.
Who cannot join
- Subjects who are unable to read or speak English.
- Patients desiring autologous reconstruction.
- BMI >40.
- History of radiation therapy to the breast(s), e.g. history of breast conservation therapy.
- Current nicotine and/or tobacco use.
- Documented diagnosis of chronic pain.
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- Women who are pregnant or breast-feeding *
- Women who decline the use of acellular dermal matrix (ADM).
- Surgeon decision not to proceed with tissue expander reconstruction.
- Women undergoing single stage (straight to implant) reconstruction.
Trial locations and contacts
1 site in 1 country.
About this study
This study is for women scheduled to have immediate breast reconstruction following mastectomy using a tissue expander. The primary purpose of this study is to learn whether there are differences in the outcome between placing the tissue expander above the muscle or below the muscle. The study will evaluate pain, wellbeing, and overall satisfaction with reconstruction. A secondary purpose is to learn whether there are differences in complications and costs between the two locations.
- Being tested
- Subcutaneous placement, Submuscular placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous placementProcedure or surgery
The tissue expander will be placed above the muscle.
Submuscular placementProcedure or surgery
The tissue expander will be placed below the muscle
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous | Active comparator | Subcutaneous placement of tissue expander Receives: Procedure: Subcutaneous placement |
| Submuscular | Active comparator | Submuscular placement of tissue expander Receives: Procedure: Submuscular placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient satisfaction
Difference in patient satisfaction between the two groups using the physical well being scale.
Measured: Baseline, Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start1 May 2016
- Primary completion6 Feb 2020
- Study completion6 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Reconstruction Following MastectomyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minh-Doan Nguyen, Mayo Clinic
- Investigators
- Minh-Doan Nguyen, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775409
- Sponsor's protocol ID
- 16-000539
- Status last verified
- Dec 2021
- First submitted
- 13 May 2016
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Present/publish results at professional meetings/journals
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial of Subcutaneous Versus Subpectoral 2-Staged Implant-Based Breast Reconstruction
- ClinicalTrials.gov ID
- NCT02775409
- Acronym / sponsor ID
- 16-000539
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 6 Feb 2020 (actual)
- Study completion
- 6 Feb 2020 (actual)
- First posted
- 17 May 2016 (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.
This study is for women scheduled to have immediate breast reconstruction following mastectomy using a tissue expander. The primary purpose of this study is to learn whether there are differences in the outcome between placing the tissue expander above the muscle or below the muscle. The study will evaluate pain, wellbeing, and overall satisfaction with reconstruction. A secondary purpose is to learn whether there are differences in complications and costs between the two locations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous | Active comparator | Procedure: Subcutaneous placementSubcutaneous placement of tissue expander |
| Submuscular | Active comparator | Procedure: Submuscular placementSubmuscular placement of tissue expander |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women at least 18 years of age, who will undergo immediate unilateral or bilateral implant-based breast reconstruction following therapeutic skin-sparing or nipple-sparing mastectomy.
- Women at least 18 years of age, who will undergo immediate bilateral implant-based breast reconstruction following risk-reduction (prophylactic) skin-sparing or nipple-sparing mastectomy.
Key exclusion criteria (10 listed)
- Subjects who are unable to read or speak English.
- Patients desiring autologous reconstruction.
- BMI >40.
- History of radiation therapy to the breast(s), e.g. history of breast conservation therapy.
- Current nicotine and/or tobacco use.
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 |
|---|---|---|
| Subcutaneous placementThe tissue expander will be placed above the muscle. | Procedure or surgery | Subcutaneous |
| Submuscular placementThe tissue expander will be placed below the muscle | Procedure or surgery | Submuscular |
Primary outcome
Change in patient satisfaction
Time frame: Baseline, Year 3
Difference in patient satisfaction between the two groups using the physical well being scale.
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 30 Dec 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Present/publish results at professional meetings/journals
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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.
Minh-Doan Nguyen, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous placement and Submuscular placement in people with Breast Reconstruction Following Mastectomy, run by Mayo Clinic at 1 site 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 2 inclusion and 10 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 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in patient satisfaction (time frame: Baseline, Year 3). 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 30 Dec 2021.