Breast Reconstruction
Conditions
Keywords
Prosthetic, Breast tissue expander, 20-565
Brief summary
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.
Interventions
PROCEDUREPrepectoral Prosthetic Breast Reconstruction
The prepectoral approach involves placing the tissue expander on top of the pectoralis muscle.
PROCEDURESubpectoral Prosthetic Breast Reconstruction
The subpectoral approach involves placing the tissue expander under the pectoralis muscle with or without acellular dermal matrix (ADM).
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| major perioperative complications | 90 days | 90-day major complications for tissue expanders (i.e., infection, explantation, and reoperation for mastectomy flap necrosis): * Infection: any event requiring restart of antibiotics (oral or intravenous) following completion of initial perioperative antibiotics or an admission to the hospital for cellulitis. * Explantation: need for tissue expander removal for any cause. * Reoperation: skin excision performed in either the clinic or the main operating room for mastectomy skin flap necrosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| minor complications | 90 days | Minor complication for tissue expanders is defined as: Seroma: clinically significant non-infected fluid collection requiring either needle aspiration or drain replacement |
Countries
United States
Outcome results
None listed