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| Name | Class |
|---|---|
| The Plastic Surgery Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prepectoral Breast Reconstruction with ADM | Experimental |
| |
| Prepectoral Breast Reconstruction without ADM | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) | Procedure | Prepectoral Breast Reconstruction with (ADM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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):
| 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate rates of minor complications (specifically seroma) | Minor complication for (Tissue Expanders) TEs are defined as: o Seroma: Clinically significant noninfected fluid collection requiring either needle aspiration or drain replacement | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
Breast Cancer
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| Name | Affiliation | Role |
|---|---|---|
| Evan Matros, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41811168 | Derived | 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. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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| Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM) | Procedure | Prepectoral Breast Reconstruction without ADM |
|
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) |
| Rockville Centre |
| New York |
| 11553 |
| United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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