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

Overview

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Judy Boughey, M.D.

Closed for enrollment

Contact information:

Sheri Ramaker R.N.

(507)538-6984

ramaker.sheri@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20207762

Mayo Clinic Footer