Study Stopped
Study recommended for closure
Comparing Two Different Surgical Techniques for Breast Reconstruction
A Randomized Controlled Trial of Prepectoral Versus Subpectoral Prosthetic Breast Reconstruction
1 other identifier
interventional
N/A
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2021
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2021
CompletedFirst Submitted
Initial submission to the registry
January 19, 2021
CompletedFirst Posted
Study publicly available on registry
January 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2021
CompletedJanuary 3, 2022
December 1, 2021
11 months
January 19, 2021
December 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
major perioperative complications
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.
90 days
Secondary Outcomes (1)
minor complications
90 days
Study Arms (2)
Prepectoral Prosthetic Breast Reconstruction
EXPERIMENTALSubpectoral Prosthetic Breast Reconstruction
ACTIVE COMPARATORInterventions
The prepectoral approach involves placing the tissue expander on top of the pectoralis muscle.
The subpectoral approach involves placing the tissue expander under the pectoralis muscle with or without acellular dermal matrix (ADM).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering BaskingRidge (Consent and Followup)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent and Followup)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent and Followup )
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack (Consent and Followup)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent and Followup)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent and Followup)
Rockville Centre, New York, 11553, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Evan Matros, MD, MMSc, MPH
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2021
First Posted
January 20, 2021
Study Start
January 14, 2021
Primary Completion
December 13, 2021
Study Completion
December 13, 2021
Last Updated
January 3, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.