The Role of Amnion Membrane Allografts in Nipple Preservation

NANot yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

August 23, 2024

Study Completion Date

August 23, 2025

Conditions
MastectomyGender Affirmation SurgeryNipple Sparing MastectomyProphylactic MastectomyBenign Breast Condition
Interventions
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.

Trial Locations (1)

94304

Division of Plastic & Reconstructive Surgery, Palo Alto

All Listed Sponsors
lead

Stanford University

OTHER

NCT06073808 - The Role of Amnion Membrane Allografts in Nipple Preservation | Biotech Hunter | Biotech Hunter