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Comparing Two Different Surgical Techniques for Breast Reconstruction

NCT04716959 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-01-03

No results posted yet for this study

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

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).

Sponsors & Collaborators

Principal Investigators

  • Evan Matros, MD, MMSc, MPH · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-14
Primary Completion
2021-12-13
Completion
2021-12-13

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04716959 on ClinicalTrials.gov