Comparing AlloDerm and DermACELL in Breast Reconstruction

Johns Hopkins University50 enrolled

Overview

This study will compare 90-day complication rates between breasts reconstructed with tissue expanders and AlloDerm vs. DermACELL, with each patient serving as her own comparator.

The investigators' study aims to determine if there is a significant difference in postoperative outcomes when using DermACELL or AlloDerm, two acellular dermal matrix products, in breast reconstruction. Patients who are undergoing bilateral mastectomies with tissue expanders and acellular dermal matrix (ADM) with one of the investigators' two surgeons, Dr. Steven Davison or Dr. Ximena Pinell, are eligible to be enrolled. Patients' breasts will be randomized to receive either AlloDerm or DermACELL so that each patient had AlloDerm placed in one breast and DermACELL placed in the other on the day of surgery. Then, the following data for each breast will be recorded: time until drain removal, total drain output, time until first expander fill, and occurrences of infection and seroma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Acellular Dermal Matrix in Breast Reconstruction

Interventions

AlloDermOTHER

Enrolled patients will have one of their breasts reconstructed with AlloDerm at the time of their breast reconstruction surgery.

DermACELLOTHER

Enrolled patients will have one of their breasts reconstructed with DermACELL at the time of their breast reconstruction surgery.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female patients over the age of 18 * May be undergoing either therapeutic or prophylactic mastectomy * Must be undergoing bilateral mastectomy and breast reconstruction with tissue expanders Exclusion Criteria: * Patients who wish to avoid the use of ADM in their reconstruction * History of radiation of the breast * Unilateral mastectomies * Direct to implant breast reconstruction (not utilizing a tissue expander)

Locations (2)

DAVinci Plastic Surgery

Washington D.C., District of Columbia, United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

Drain time

Number of days between surgical placement of drains and time until drains are removed.

Time frame: Up to 90 days

Drain output

Total amount of fluid collected by the drains until their removal (measured in cc).

Time frame: Up to 90 days

Incidence of Seroma

Each patient will be evaluated for incidence of seroma in either breast at postoperative visits.

Time frame: Up to 90 days

Incidence of Infection

Each patient will be evaluated for incidence of infection in either breast at postoperative visits.

Time frame: Up to 90 days

Secondary Outcomes

Incidence of Skin necrosis

Each patient will be evaluated for skin necrosis of either breast at postoperative visits.

Time frame: Up to 90 days

Incidence of Hematoma

Each patient will be evaluated for incidence of hematoma in either breast at postoperative visits.

Time frame: Up to 90 days

Incidence of Device Explantation

If patients require device explantation in one breast due to complications (e.g. infection).

Time frame: Up to 90 days

Data from ClinicalTrials.gov

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