A Retrospective Breast Reconstruction Study

Completed

Conditions studied: Breast Cancer

In brief

To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.

Key facts

Study ID

NCT04060134

Run by

Elutia Inc.

People needed

223

Starts

2019-11-20

Expected to finish

2022-06-01

Last updated by the study team

2024-02-14

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patient who underwent immediate breast reconstruction post-mastectomy; either direct to implant or with a tissue expander followed by exchange for a saline or gel implant.
• HADMs such as: InteguPly, SimpliDerm, AlloDerm, FlexHD, DermACELL, Cortiva, or AlloMax used in the breast reconstruction.

You may not qualify if…

• Female patient who underwent cosmetic/aesthetic breast augmentation procedure or revision.
• Female patient who underwent delayed breast reconstruction procedure.
• Female patient who underwent revision of previous breast reconstruction procedure.

Where it is running

• Baptist Medical Center South — Montgomery, Alabama, United States
• Shoals Plastic Surgery — Muscle Shoals, Alabama, United States
• Tierney Plastic Surgery — Nashville, Tennessee, United States
• Ascension/Seton Institute of Reconstructive Plastic Surgery — Austin, Texas, United States
• DHR Health — McAllen, Texas, United States

Full record on ClinicalTrials.gov

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