The Role of Amnion Membrane Allografts in Nipple Preservation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft, Control Device.
- Who it may be relevant to
- Registry conditions: Mastectomy, Gender Affirmation Surgery, Nipple Sparing Mastectomy, Prophylactic Mastectomy. Basic parameters: 15 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Role of Amnion Membrane Allografts in Nipple Preservation After Nipple Sparing Mastectomy: A Double-Blinded Randomized Controlled Trial
Overview
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.
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 derma - Device Control Device
Control device will be applied to non-experimental breast. Each patient will serve as their own control.
Primary outcome measures
- 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]
Secondary outcome measures (5)
- Rate of Nipple Healing [Time frame: through study completion, an average of 3 months post op]
- Degree of nipple loss [Time frame: through study completion, an average of 3 months post op]
- Nipple perfusion [Time frame: through study completion, an average of 3 months post op]
- Aesthetic satisfaction scale score; scale used is a likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied [Time frame: through study completion, an average of 3 months post op]
- Number of Participants with Nipple Sensation [Time frame: through study completion, an average of 3 months post op]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Division of Plastic & Reconstructive Surgery — Palo Alto
Identifiers
NCT: NCT06073808 · 71564