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

Stanford University

Status: Not yet enrolling

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

Treatments: Device: AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft; Device: Control Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06073808

71564

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 15 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Assess dHACM viability

Experimental group

Description:

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.

Treatment:

Device: AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft

Assess dHACM effectiveness against control device

Active Comparator group

Description:

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.

Treatment:

Device: Control Device