Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Prepectoral Breast Reconstruction with (ADM)

Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)

Prepectoral Breast Reconstruction without ADM

Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)

Evan Matros, MD

Jonas Nelson, MD

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.

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

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.

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

Minor complication for (Tissue Expanders) TEs are defined as:

o Seroma: Clinically significant noninfected fluid collection requiring either needle aspiration or drain replacement

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction	NCT05316324	Breast Cancer	Prepectoral Bre... Prepectoral Bre...	21 Years - 75 Years	Memorial Sloan Kettering Cancer Center
A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction	NCT05316324	Breast Cancer	Prepectoral Bre... Prepectoral Bre...	21 Years - 75 Years	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for prepectoral breast reconstruction with acellular dermal matrix (adm)