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NCT Number: NCT06073808

The Role of Amnion Membrane Allografts in Nipple Preservation

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.

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Key information

Conditions

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

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Plastic & Reconstructive Surgery

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft

Device

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

Control Device

Device

Control device will be applied to non-experimental breast. Each patient will serve as their own control.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Dung Nguyen, MD, PharmD

CONTACT

[email protected]

Kassandra Carrion

CONTACT

[email protected]

650-498-6004

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: AmnioFix

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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