Prospective Trial of Subcutaneous Versus Subpectoral 2-Staged Implant-Based Breast Reconstruction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in patient satisfaction
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Subjects who are unable to read or speak English.
- •Patients desiring autologous reconstruction.
- •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.
- •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.
Arms & Interventions
Subcutaneous
Subcutaneous placement of tissue expander
Intervention: Subcutaneous placement (Procedure)
Submuscular
Submuscular placement of tissue expander
Intervention: Submuscular placement (Procedure)
Outcomes
Primary Outcomes
Change in patient satisfaction
Time Frame: Baseline, Year 3
Difference in patient satisfaction between the two groups using the physical well being scale.
Secondary Outcomes
No secondary outcomes reported
Investigators
Minh-Doan Nguyen
Assistant Professor of Plastic Surgery
Mayo Clinic