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

NCT06073808 NA NOT_YET_RECRUITING

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.

Details

Lead sponsor	Stanford University
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	30
Start date	2026-06-01
Completion	2026-09

Conditions

• Mastectomy
• Gender Affirmation Surgery
• Nipple Sparing Mastectomy
• Prophylactic Mastectomy
• Benign Breast Condition

Interventions

• AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft
• Control Device

Primary outcomes

• 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.

Countries

United States