The Role of Amnion Membrane Allografts in Nipple Preservation

Starting soon · Not applicable

Conditions studied: Mastectomy, Gender Affirmation Surgery, Nipple Sparing Mastectomy, Prophylactic Mastectomy, Benign Breast Condition

In brief

The overall objective of this proposal is to conduct a randomized-controlled study to determine whether treatment with dehydrated human amnion/chorion membrane (dHACMs) allografts can improve NAC viability in patients undergoing nipple sparing mastectomy (NSM). dHACM allografts are commercially available tissue membranes with biocompatible extracellular matrix and growth factors that have been shown to improve wound healing in patients with chronic and lower extremity wounds. To date, no study has evaluated the impact of dHACMs on NAC preservation following NSM. Investigators hypothesize that subareolar surgical implantation of dHACM allografts at time of NSM will reduce NAC necrosis and improve viability.

Key facts

Study ID: NCT06073808
Run by: Stanford University
People needed: 30
Starts: 2026-06-01
Expected to finish: 2026-09-01
Last updated by the study team: 2026-04-30

Who can join

Age: 15 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Biologically female with documented diagnosis of gender dysphoria, desire to undergo gender affirming surgery (female-to-male) NSM, and age 15 years of age or older.
Biological female, age 18 to 75 years old, who desire to undergo bilateral prophylactic NSM for nonmalignant breast conditions or to reduce the risk of breast cancer.

You may not qualify if…

Current steroid use
Known connective tissue disorder
Known neuropathy
Known history of breast cancer
History of breast radiotherapy
Pregnant or nursing

Where it is running

Division of Plastic & Reconstructive Surgery — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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