Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial

Memorial Sloan Kettering Cancer Center70 enrolled

Overview

Following mastectomy (removal of your breast), reconstruction of your breast(s) can be performed using tissue expanders and implants. At the same operation as your mastectomy, a tissue expander is put under the skin and muscles of your chest. Following your surgery, the tissue expander is gradually filled with salt water over a period of months. Once the expander is filled to the size of your new breast, a second operation is performed. At this time, the tissue expander is removed and a permanent breast implant is placed. This is a standard procedure. We are interested in learning about the use of AlloDerm in breast reconstruction. AlloDerm can be used instead of some of your own chest muscles, in order to cover and protect a tissue expander. We want to know if the use of AlloDerm can decrease your pain or discomfort after surgery and after the filling of your tissue expander. AlloDerm is made from human tissue. When AlloDerm is made all the cells that could cause your body to reject it are removed. When it is placed in your chest, your own cells will then grow into the AlloDerm, causing it to act like the muscle it is replacing. In this study, you will either have reconstruction with AlloDerm or without AlloDerm.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Breast Cancer

Interventions

Alloderm, QuestionnairesPROCEDURE

All patients will undergo placement of a temporary tissue expander immediately following mastectomy.Patients will undergo the surgical creation of an expander pocket using implantable Alloderm.

Without ALLODERM, QuestionnairesPROCEDURE

A standard, sub-muscular pocket dissection will be performed in the patients assigned to the control group. No Alloderm will be used.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who undergo immediate, postmastectomy, tissue expander/implant reconstruction * Patients ≥ 21 and ≤ 75 years of age Exclusion Criteria: * Patient refusal * Patients who will undergo any of the following: * Single-stage implant reconstruction * Combined autogenous tissue expander/implant reconstruction * Patients with a history of prior irradiation * Patients with a history of prior surgery with breast implants * Patients with a history of prior axillary lymph node dissection * Patients who are pregnant The following eligibility will be confirmed at the time of surgery. * Patients who are deemed intraoperatively by the attending surgeon to have significant mastectomy flap ischemia. * Patients who have an axillary lymph node dissection at the time of mastectomy (Patients undergoing sentinel lymph biopsy are eligible)

Locations (3)

University of Michigan Health System

Ann Arbor, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of North Carolina School of Medicine

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

whether using Alloderm to create the inferior-medial portion of the expander pocket will decrease patient-reported pain in both the immediate, post-operative period and during the expansion phase.