A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction

Phase 3Active Not RecruitingNCT05316324

Memorial Sloan Kettering Cancer Center353 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

353

Conditions

Breast Cancer

Interventions

Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)PROCEDURE

Prepectoral Breast Reconstruction with (ADM)

Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)PROCEDURE

Prepectoral Breast Reconstruction without ADM

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * History of radiotherapy to the operative breast * Current smoker * Non-English speaking patients * Planning to undergo direct-to-implant reconstruction * Prior sternotomy

Locations (2)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Rockville Centre, New York, United States

Outcomes

Primary Outcomes

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

Time frame: 90 days

Secondary Outcomes

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

Time frame: 90 days

Data from ClinicalTrials.gov

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