The Role of Amnion Membrane Allografts in Nipple Preservation

Not Applicable

Not yet recruiting

• Conditions: Gender Affirmation Surgery; Prophylactic Mastectomy; Benign Breast Condition; Nipple Sparing Mastectomy; Mastectomy
• Interventions: Device: AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft; Device: Control Device

• Registration Number: NCT06073808
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2023-09-09
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Study Start: 2024-06-01
• Primary Completion: 2024-08-23
• Study Completion: 2025-08-23

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Assess dHACM viability	AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft	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.
Assess dHACM effectiveness against control device	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.

Primary Outcome Measures

Name	Time	Method
Rate of Nipple Necrosis in patients who receive dHACM during nipple sparing mastectomy (NSM)	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 Outcome Measures

Name	Time	Method
Rate of Nipple Healing	through study completion, an average of 3 months post op	Number of nipples that have healed per clinician assessment.
Degree of nipple loss	through study completion, an average of 3 months post op	Number of nipples partially or wholly lost to necrosis.
Nipple perfusion	through study completion, an average of 3 months post op	Perfusion of blood in the nipple assessed via indocyanine green (ICG)-SPY technology.
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	Participant-rated satisfaction.
Number of Participants with Nipple Sensation	through study completion, an average of 3 months post op	Participants indicated whether they have nipple sensation (innervation) (Y/N).

Trial Locations

Locations (1)

Division of Plastic & Reconstructive Surgery; 🇺🇸 Palo Alto, California, United States