Comparing Two Different Surgical Techniques for Breast Reconstruction
Purpose
The purpose of this study is to compare two standard techniques for breast reconstruction-the prepectoral technique and the subpectoral technique. Again, the prepectoral technique involves putting a tissue expander on top of the pectoralis muscle, while the subpectoral technique involves putting a tissue expander under the pectoralis muscle. The standard approach used at MSK is the subpectoral technique. This study will help researchers find out whether the subpectoral approach is better, the same as, or worse than the prepectoral approach. To decide which approach is better, the researchers will look at which technique causes fewer complications after surgery (for example, infection or the need for a second surgery). Researchers are also interested in seeing which approach causes less pain and use of pain medication after surgery.
Condition
- Breast Reconstruction
Eligibility
- Eligible Ages
- Between 21 Years and 60 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Women aged 21-60 years - Planning to undergo immediate two stage prosthetic breast reconstruction with TE placement as the first stage. - Planning to undergo unilateral or bilateral mastectomy. - Planning to undergo nipple- or skin-sparing mastectomy. - Mastectomy weight less than 800 grams. - Adequate mastectomy skin perfusion or patients with adequate perfusion but nonviable mastectomy skin that can be excised (≤ 4 cm) at the defect margins with otherwise adequate perfusion.
Exclusion Criteria
- Receipt of neoadjuvant chemotherapy for locally advanced breast cancer. - Presence of preoperative axillary lymph node metastasis. - Presence of intraoperative sentinel node positivity. - History of radiotherapy. - Current smoker. - Planning to undergo direct-to-implant reconstruction. - BMI >35. - Prior sternotomy.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Prepectoral Prosthetic Breast Reconstruction |
|
|
|
Active Comparator Subpectoral Prosthetic Breast Reconstruction |
|
Recruiting Locations
More Details
- NCT ID
- NCT04716959
- Status
- Withdrawn
- Sponsor
- Memorial Sloan Kettering Cancer Center