The Role of Amnion Membrane Allografts in Nipple Preservation

Mastectomy Clinical Trial

— AmnioFix  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06073808
• Other study ID #: 71564
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: August 23, 2025

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Kassandra Carrion
• Phone: 650-498-6004
• Email: kcarrion[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 23, 2025
• Est. primary completion date: August 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

Inclusion Criteria:

• Biologically female with documented diagnosis of gender dysphoria, desire to undergo gender affirming surgery (female-to-male) NSM, and age 15 years of age or older.

• Biological female, age 18 to 75 years old, who desire to undergo bilateral prophylactic NSM for nonmalignant breast conditions or to reduce the risk of breast cancer.

Exclusion Criteria:

• Current steroid use

• Known connective tissue disorder

• Known neuropathy

• Known history of breast cancer

• History of breast radiotherapy

• Pregnant or nursing

Related Conditions & MeSH terms

• Mastectomy
• Nipple Sparing Mastectomy
• Prophylactic Mastectomy

Intervention

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.
• Control Device
Control device will be applied to non-experimental breast. Each patient will serve as their own control.

Locations

Country	Name	City	State
United States	Division of Plastic & Reconstructive Surgery	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Nipple Necrosis in patients who receive dHACM during nipple sparing mastectomy (NSM)	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.	through study completion, an average of 3 months post op
Secondary	Rate of Nipple Healing	Number of nipples that have healed per clinician assessment.	through study completion, an average of 3 months post op
Secondary	Degree of nipple loss	Number of nipples partially or wholly lost to necrosis.	through study completion, an average of 3 months post op
Secondary	Nipple perfusion	Perfusion of blood in the nipple assessed via indocyanine green (ICG)-SPY technology.	through study completion, an average of 3 months post op
Secondary	Aesthetic satisfaction scale score; scale used is a likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied	Participant-rated satisfaction.	through study completion, an average of 3 months post op
Secondary	Number of Participants with Nipple Sensation	Participants indicated whether they have nipple sensation (innervation) (Y/N).	through study completion, an average of 3 months post op