The Role of Amnion Membrane Allografts in Nipple Preservation (AmnioFix)

April 24, 2026 updated by: Dung Nguyen, Stanford University

The Role of Amnion Membrane Allografts in Nipple Preservation After Nipple Sparing Mastectomy: A Double-Blinded Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This proposal will be the first clinical trial to evaluate the clinical efficacy of dHACM allografts in NSM. The topic of study not only addresses a critically unmet need in the field of plastic surgery, but also maintains exceptional scientific and clinical merit. This study would be the first to establish dHACM allografts as a novel, innovative, and biologically-based adjunctive mechanism to improve vascularity and wound healing following NSM. Such findings would not only provide the evidence-base for widespread implementation of dHACM allografts in the surgical management of breast patients, but also serve as a catalyst to study the clinical efficacy of these allografts in other plastic surgical patient cohorts. Overall, this proposal aims to serve as a successful translational model incorporating scalable, biologically-based regenerative therapies in a surgical population.

Nipple necrosis is a major complication after nipple sparing mastectomy, a procedure that is commonly performed in the human population for gender reassignment surgery and for breast cancer prevention. This study will assess the efficacy of dHACMs can improve nipple viability after NSM.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Division of Plastic & Reconstructive Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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 Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Assess dHACM viability
Implantation of dHACM in patients during Nipple Sparing Mastectomy; test arm. The device will be implanted in one breast per patient during bilateral nipple sparing mastectomy.
Device: AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft
Dehydrated human amnion/chorion membrane (dHACMs) allografts have recently been identified as an easy-to-use treatment alternative for management of chronic wounds. These commercially available allografts contain concentrated cytokines and growth factors known to promote wound healing. Preclinical studies suggest that dHACM allografts provide a complex, biologically-driven mechanism to promote soft tissue repair and regeneration, including stimulation of mesenchymal stem cell migration and dermal fibroblast proliferation, establishment of a supportive inflammatory environment, and restoration of extracellular matrix integrity with positive tissue architecture remodeling. Clinically, dHACM allografts have been shown to improve healing time and wound closure rates in chronic wound patients. However, no study to date has evaluated the impact of dHACM allografts on nipple necrosis following NSM.
Other Names:
  • AmnioFix
Active Comparator: Assess dHACM effectiveness against control device
Implantation of control device in patients during Nipple Sparing Mastectomy; control arm. The device will be implanted in one breast per patient during bilateral nipple sparing mastectomy.
Device: Control Device
Control device will be applied to non-experimental breast. Each patient will serve as their own control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Nipple Necrosis in patients who receive dHACM during nipple sparing mastectomy (NSM)
Time Frame: 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.
through study completion, an average of 3 months post op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Nipple Healing
Time Frame: through study completion, an average of 3 months post op
Number of nipples that have healed per clinician assessment.
through study completion, an average of 3 months post op
Degree of nipple loss
Time Frame: through study completion, an average of 3 months post op
Number of nipples partially or wholly lost to necrosis.
through study completion, an average of 3 months post op
Nipple perfusion
Time Frame: through study completion, an average of 3 months post op
Perfusion of blood in the nipple assessed via indocyanine green (ICG)-SPY technology.
through study completion, an average of 3 months post op
Aesthetic satisfaction scale score; scale used is a likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied
Time Frame: through study completion, an average of 3 months post op
Participant-rated satisfaction.
through study completion, an average of 3 months post op
Number of Participants with Nipple Sensation
Time Frame: through study completion, an average of 3 months post op
Participants indicated whether they have nipple sensation (innervation) (Y/N).
through study completion, an average of 3 months post op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Dung Nguyen, MD, PharmD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

September 9, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 71564

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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