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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Acellular Dermal Matrix in Breast Reconstruction

NCT number NCT04710537
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase N/A
Start date October 21, 2021
Completion date July 26, 2022