NCT04716959

Comparing Two Different Surgical Techniques for Breast Reconstruction

A Randomized Controlled Trial of Prepectoral Versus Subpectoral Prosthetic Breast Reconstruction

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Reconstruction

Interventions

Type	Name	Description
PROCEDURE	Prepectoral Prosthetic Breast Reconstruction	The prepectoral approach involves placing the tissue expander on top of the pectoralis muscle.
PROCEDURE	Subpectoral Prosthetic Breast Reconstruction	The subpectoral approach involves placing the tissue expander under the pectoralis muscle with or without acellular dermal matrix (ADM).

Timeline

• Start date: 2021-01-14
• Primary completion: 2021-12-13
• Completion: 2021-12-13
• First posted: 2021-01-20
• Last updated: 2022-01-03

Locations

7 sites across 1 country: United States