The Role of Amnion Membrane Allografts in Nipple Preservation

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06073808
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
15 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft — DEVICE
    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 — DEVICE
    Control device will be applied to non-experimental breast. Each patient will serve as their own control.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Assess dHACM viability
    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.
  • Active Comparator: Assess dHACM effectiveness against 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 Measure

Rate of Nipple Necrosis in patients who receive dHACM during nipple sparing mastectomy (NSM) [ Time Frame: through study completion, an average of 3 months post op ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Division of Plastic & Reconstructive SurgeryPalo AltoCalifornia94304-

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Division of Plastic & Reconstructive Surgery· Palo Alto, CA

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