NCT04710537

Comparing AlloDerm and DermACELL in Breast Reconstruction

Comparing AlloDerm and DermACELL in Breast Reconstruction: A Randomized Laterality

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acellular Dermal Matrix in Breast Reconstruction

Interventions

Type	Name	Description
OTHER	AlloDerm	Enrolled patients will have one of their breasts reconstructed with AlloDerm at the time of their breast reconstruction surgery.
OTHER	DermACELL	Enrolled patients will have one of their breasts reconstructed with DermACELL at the time of their breast reconstruction surgery.

Timeline

• Start date: 2021-10-21
• Primary completion: 2022-07-26
• Completion: 2022-07-26
• First posted: 2021-01-14
• Last updated: 2022-08-04

Locations

2 sites across 1 country: United States