Trials / Completed
CompletedNCT02775409
Prospective Trial of Subcutaneous Versus Subpectoral 2-Staged Implant-Based Breast Reconstruction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Subcutaneous placement | The tissue expander will be placed above the muscle. |
| PROCEDURE | Submuscular placement | The tissue expander will be placed below the muscle |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2020-02-06
- Completion
- 2020-02-06
- First posted
- 2016-05-17
- Last updated
- 2021-12-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02775409. Inclusion in this directory is not an endorsement.