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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

353 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-23

Study Completion Date

2026-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prepectoral Breast Reconstruction with ADM

Group Type EXPERIMENTAL

Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)

Intervention Type PROCEDURE

Prepectoral Breast Reconstruction with (ADM)

Prepectoral Breast Reconstruction without ADM

Group Type EXPERIMENTAL

Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)

Intervention Type PROCEDURE

Prepectoral Breast Reconstruction without ADM

Interventions

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Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)

Prepectoral Breast Reconstruction with (ADM)

Intervention Type PROCEDURE

Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)

Prepectoral Breast Reconstruction without ADM

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No