A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction
A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Acellular Dermal Matrix
1 other identifier
interventional
353
1 country
2
Brief Summary
The researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when ADM is not used. These complications include infections, the need for Tissue Expander (TE) or implant removal, and other conditions that lead to additional surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 breast-cancer
Started Mar 2022
2 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
First Submitted
Initial submission to the registry
March 23, 2022
CompletedStudy Start
First participant enrolled
March 23, 2022
CompletedFirst Posted
Study publicly available on registry
April 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
February 17, 2026
February 1, 2026
4.9 years
March 23, 2022
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients who experience major complications
Listed below are definitions for 90-day major complications for TEs (i.e., infection, explantation, and reoperation for any cause, including mastectomy flap necrosis): * Infection defined as: * Any event requiring the restart of antibiotics (oral or intravenous) after completion of initial perioperative antibiotics * Admission to the hospital for signs and symptoms of cellulitis (redness on breast mound) requiring antibiotics * Purulent drainage from the surgical site or incision * Explantation defined as the need for removal of a TE for any cause * Reoperation defined as skin excision performed in either the clinic or the operating room for mastectomy skin flap necrosis, surgical incision dehiscence, pending skin breakdown or another surgical complication
90 days
Secondary Outcomes (1)
Estimate rates of minor complications (specifically seroma)
90 days
Study Arms (2)
Prepectoral Breast Reconstruction with ADM
EXPERIMENTALPrepectoral Breast Reconstruction without ADM
EXPERIMENTALInterventions
Prepectoral Breast Reconstruction with (ADM)
Prepectoral Breast Reconstruction without ADM
Eligibility Criteria
You may qualify if:
- Females aged 21-60 years
- Planning to undergo unilateral or bilateral mastectomy, prophylactically or to treat breast cancer
- Planning to undergo immediate two-stage prosthetic breast reconstruction with TE placement as the first stage
- Planning to undergo nipple-sparing or skin-sparing mastectomy
- Adequate mastectomy skin perfusion or adequate perfusion but nonviable mastectomy skin that can be excised (≤4 cm) at the defect margins with otherwise adequate perfusion
- Intraoperative confirmation of prepectoral plane viability by operating physician
You may not qualify if:
- History of radiotherapy to the operative breast
- Current smoker
- Non-English speaking patients
- Planning to undergo direct-to-implant reconstruction
- Prior sternotomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, 11553, United States
Related Publications (1)
Nelson JA, Shammas RL, Boe LA, Gonen M, Poulton RT, Stern CS, Rochlin DH, McCarthy CM, Allen RJ Jr, Coriddi M, Disa JJ, Mehrara BJ, Matros E. Two-Stage Prepectoral Breast Reconstruction with and without Acellular Dermal Matrix: A Cluster-Randomized Noninferiority Trial. Plast Reconstr Surg. 2026 Mar 11. doi: 10.1097/PRS.0000000000013019. Online ahead of print.
PMID: 41811168DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evan Matros, MD
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
March 23, 2022
First Posted
April 7, 2022
Study Start
March 23, 2022
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02
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.