Comparing Two Different Surgical Techniques for Breast Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-14

Study Completion Date

2021-12-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prepectoral Prosthetic Breast Reconstruction

Group Type EXPERIMENTAL

Prepectoral Prosthetic Breast Reconstruction

Intervention Type PROCEDURE

The prepectoral approach involves placing the tissue expander on top of the pectoralis muscle.

Subpectoral Prosthetic Breast Reconstruction

Group Type ACTIVE_COMPARATOR

Subpectoral Prosthetic Breast Reconstruction

Intervention Type PROCEDURE

The subpectoral approach involves placing the tissue expander under the pectoralis muscle with or without acellular dermal matrix (ADM).

Interventions

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Prepectoral Prosthetic Breast Reconstruction

The prepectoral approach involves placing the tissue expander on top of the pectoralis muscle.

Intervention Type PROCEDURE

Subpectoral Prosthetic Breast Reconstruction

The subpectoral approach involves placing the tissue expander under the pectoralis muscle with or without acellular dermal matrix (ADM).

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No