Clinical trial NCT06073808: The Role of Amnion Membrane Allografts in Nipple Preservation
Official title: The Role of Amnion Membrane Allografts in Nipple Preservation After Nipple Sparing Mastectomy: A Double-Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mastectomy
Gender Affirmation Surgery
Nipple Sparing Mastectomy
Prophylactic Mastectomy
Benign Breast Condition
Keywords: nipple sparing mastectomy
gender affirming surgery
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Each patient will serve as their own control: one breast will receive the control device, and the other will receive the study device.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Nipple Necrosis in patients who receive dHACM during nipple sparing mastectomy (NSM)
timeFrame: through study completion, an average of 3 months post op
Secondary outcomes:
measure: Rate of Nipple Healing
timeFrame: through study completion, an average of 3 months post op
measure: Degree of nipple loss
timeFrame: through study completion, an average of 3 months post op
measure: Nipple perfusion
timeFrame: through study completion, an average of 3 months post op
measure: Aesthetic satisfaction scale score; scale used is a likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied
timeFrame: through study completion, an average of 3 months post op
measure: Number of Participants with Nipple Sensation
timeFrame: through study completion, an average of 3 months post op
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Division of Plastic & Reconstructive Surgery
state: California
Study officials:
affiliation: Stanford University
name: Dung Nguyen, MD, PharmD
role: PRINCIPAL_INVESTIGATOR
References: