The Role of Amnion Membrane Allografts in Nipple Preservation

NCT06073808 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 71564
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

nipple sparing mastectomy; gender affirming surgery

Outcome Measures

Primary Outcomes (1)

• Rate of Nipple Necrosis in patients who receive dHACM during nipple sparing mastectomy (NSM)

  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 Outcomes (5)

• Rate of Nipple Healing

  through study completion, an average of 3 months post op

• Degree of nipple loss

  through study completion, an average of 3 months post op

• Nipple perfusion

  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

  through study completion, an average of 3 months post op

• Number of Participants with Nipple Sensation

  through study completion, an average of 3 months post op

Study Arms (2)

Assess dHACM viability

EXPERIMENTAL

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

Assess dHACM effectiveness against control device

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: AmnioFix

Assess dHACM viability

Control Device DEVICE

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

Assess dHACM effectiveness against control device

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Division of Plastic & Reconstructive Surgery

Palo Alto, California, 94304, United States

Location

Study Officials

• Dung Nguyen, MD, PharmD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kassandra Carrion

CONTACT

650-498-6004; kcarrion@stanford.edu

Dung Nguyen, MD, PharmD

CONTACT

nguyendh@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Director of Breast Reconstruction, Director of Adult Plastics and Reconstructive Clinic, Associate Director of Microsurgery

Model Details: Each patient will serve as their own control: one breast will receive the control device, and the other will receive the study device.

Study Record Dates

• First Submitted: September 9, 2023
• First Posted: October 10, 2023
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)