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Amnion Membrane Allografts for Nipple Preservation After Mastectomy

This study is looking at whether a special tissue called AmnioFix (dehydrated Human Amnion/Chorion Membrane Allograft) can help improve nipple health after nipple-sparing mastectomy (a surgery where the nipple is kept). AmnioFix contains natural substances that help wounds heal. Researchers want to see if applying AmnioFix during surgery can reduce the chance of nipple necrosis (when nipple tissue dies). You might be able to join if you are a biological female aged 15-75 and are having a nipple-sparing mastectomy for gender affirmation surgery or to reduce your risk of breast cancer. The study aims to see how well the nipple survives, with results expected about three months after surgery. The current recruitment status is unclear.

Study design
This is a randomized-controlled study planning to enroll 30 participants. Each patient will receive AmnioFix on one breast and a control device on the other, serving as their own comparison.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, nipple necrosis rate, will be measured through study completion, which is an average of 3 months post-operation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06073808

The Role of Amnion Membrane Allografts in Nipple Preservation

Not Yet Recruiting
NAAges 15–75InterventionalTreatment
Stanford University
~30 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:AmnioFix dehydrated Human Amnion/Chorion Membrane AllograftControl Device

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Nipple Necrosis in patients who receive dHACM during nipple sparing mastectomy (NSM)
Measured over through study completion, an average of 3 months post op

Conditions

Mastectomy
Gender Affirmation Surgery
Nipple Sparing Mastectomy
Prophylactic Mastectomy
Benign Breast Condition

Explore related trials

Benign breast conditionGender Dysphoria

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Dung Nguyen, MD, PharmD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Kassandra Carrion
[email protected]
650-498-6004
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Rate of Nipple Necrosis in patients who receive dHACM during nipple sparing mastectomy (NSM)through study completion, an average of 3 months post op

    The primary endpoint of this study is number of nipples with necrosis as defined by dark blue or black nipple discoloration, ultimately resulting in scabs or open wounds up to 3 months post-operatively.