NCT06073808

The Role of Amnion Membrane Allografts in Nipple Preservation

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 15 Years – 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	Control Device	Control device will be applied to non-experimental breast. Each patient will serve as their own control.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2023-10-10
• Last updated: 2025-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study