The Role of Amnion Membrane Allografts in Nipple Preservation

NCT ID: NCT06073808

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-09-30

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Control Device

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Control Device

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

Intervention Type: DEVICE

Other Intervention Names

AmnioFix

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Dung Nguyen

Clinical Professor, Director of Breast Reconstruction, Director of Adult Plastics and Reconstructive Clinic, Associate Director of Microsurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dung Nguyen, MD, PharmD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Division of Plastic & Reconstructive Surgery

Palo Alto, California, United States

Countries

United States

Central Contacts

Kassandra Carrion

Role: CONTACT

kcarrion@stanford.edu

650-498-6004

Dung Nguyen, MD, PharmD

Role: CONTACT

nguyendh@stanford.edu

Other Identifiers

71564

Identifier Type: -

Identifier Source: org_study_id