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The Role of Amnion Membrane Allografts in Nipple Preservation
Sponsor: Stanford University
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.
Official title: The Role of Amnion Membrane Allografts in Nipple Preservation After Nipple Sparing Mastectomy: A Double-Blinded Randomized Controlled Trial
Key Details
Gender
All
Age Range
15 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-01-01
Completion Date
2026-09
Last Updated
2025-11-17
Healthy Volunteers
Yes
Conditions
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.
Control Device
Control device will be applied to non-experimental breast. Each patient will serve as their own control.
Locations (1)
Division of Plastic & Reconstructive Surgery
Palo Alto, California, United States