Comparing Two Different Surgical Techniques for Breast Reconstruction

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Withdrawn

Phase 3

Conditions

Breast Reconstruction

Treatments

Procedure: Subpectoral Prosthetic Breast Reconstruction

Procedure: Prepectoral Prosthetic Breast Reconstruction

Study type

Interventional

Funder types

Other

Identifiers

NCT04716959

20-565

Details and patient eligibility

About

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.

Sex

Female

Ages

21 to 60 years old

Volunteers

No Healthy Volunteers

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