Comparing AlloDerm and DermACELL in Breast Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparing AlloDerm and DermACELL in Breast Reconstruction: A Randomized Laterality

Conditions
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Acellular Dermal Matrix in Breast Reconstruction

Intervention / Treatment
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* Other: AlloDerm
* Other: DermACELL


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: At the time of surgery, the assignment of AlloDerm vs. DermACELL to the patient's left and right breasts will be randomized. The surgical assistant, scrub tech, and circulators can randomly choose which acellular dermal matrix product will be used first or second. The ADM product that will be used first will be placed in either the left or right breast, depending on what breast the surgeon decided to perform the surgery on first. Then, the second breast that is operated on will receive whichever ADM product was not used on the first breast.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AlloDerm<br>AlloDerm will be surgically implanted into each participant (either in their left or right breast) at the time of their breast reconstruction surgery. AlloDERM will be placed in the breast opposite to the breast in which DermACELL is placed, so that the patient has AlloDERM in the right breast and DermACELL in the left breast, or vice versa. | Other: AlloDerm<br>* Enrolled patients will have one of their breasts reconstructed with AlloDerm at the time of their breast reconstruction surgery.<br>|
| Active Comparator: DermACELL<br>DermACELL will be surgically implanted into each participant (either in their left or right breast) at the time of their breast reconstruction surgery. DermACELL will be placed in the breast opposite to the breast in which AlloDERM is placed, so that the patient has AlloDERM in the right breast and DermACELL in the left breast, or vice versa. | Other: DermACELL<br>* Enrolled patients will have one of their breasts reconstructed with DermACELL at the time of their breast reconstruction surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drain time | Number of days between surgical placement of drains and time until drains are removed. | Up to 90 days | 
| Drain output | Total amount of fluid collected by the drains until their removal (measured in cc). | Up to 90 days | 
| Incidence of Seroma | Each patient will be evaluated for incidence of seroma in either breast at postoperative visits. | Up to 90 days | 
| Incidence of Infection | Each patient will be evaluated for incidence of infection in either breast at postoperative visits. | Up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Skin necrosis | Each patient will be evaluated for skin necrosis of either breast at postoperative visits. | Up to 90 days | 
| Incidence of Hematoma | Each patient will be evaluated for incidence of hematoma in either breast at postoperative visits. | Up to 90 days | 
| Incidence of Device Explantation | If patients require device explantation in one breast due to complications (e.g. infection). | Up to 90 days |