A Study of Subcutaneous versus Subpectoral Placement for 2-Staged Implant-Based Breast Reconstruction

Overview

  • Study type

    Interventional
  • Study phase

    0
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 16-000539
    NCT ID: NCT02775409
    Sponsor Protocol Number: 16-000539

About this study

The purpose of this study is to learn whether there are differences in the outcome between placing the tissue expander above or below the chest muscle in women having immediate breast reconstruction following a mastectomy  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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. 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.
  2. 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.

Exclusion Criteria:

  1. Subjects who are unable to read or speak English.
  2. Patients desiring autologous reconstruction.
  3. BMI >40.
  4. History of radiation therapy to the breast(s), e.g. history of breast conservation therapy.
  5. Current nicotine and/or tobacco use.
  6. Documented diagnosis of chronic pain.
  7. Women who are pregnant or breast-feeding *
  8. Women who decline the use of ADM.
  9. Surgeon decision not to proceed with tissue expander reconstruction.
  10. Women undergoing single stage (straight to implant) reconstruction.
  11. Presence of implants (submuscular or subcutaneous) from previous breast surgery.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Judy Boughey, M.D.

Open for enrollment

Contact information:

Sheri Ramaker R.N.

(507)538-6984

ramaker.sheri@mayo.edu