Comparing AlloDerm and DermACELL in Breast Reconstruction

Johns Hopkins University

Status: Completed

Conditions: Acellular Dermal Matrix in Breast Reconstruction

Treatments: Other: DermACELL; Other: AlloDerm

Study type: Interventional

Funder types: Other

Identifiers

NCT04710537

IRB00248878

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups

AlloDerm

Active Comparator group

Description:

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.

Treatment:

Other: AlloDerm

DermACELL

Active Comparator group

Description:

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.

Treatment:

Other: DermACELL