Prospective Trial of Subcutaneous Versus Subpectoral 2-Staged Implant-Based Breast Reconstruction

Mayo Clinic200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Breast Reconstruction Following Mastectomy

Interventions

Subcutaneous placementPROCEDURE

The tissue expander will be placed above the muscle.

Submuscular placementPROCEDURE

The tissue expander will be placed below the muscle

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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 acellular dermal matrix (ADM). 9. Surgeon decision not to proceed with tissue expander reconstruction. 10. Women undergoing single stage (straight to implant) reconstruction.

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change in patient satisfaction

Difference in patient satisfaction between the two groups using the physical well being scale.

Time frame: Baseline, Year 3

Data from ClinicalTrials.gov

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