MastectomyAmnioFixNCT06073808
The Role of Amnion Membrane Allografts in Nipple Preservation
A study testing AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft in people with Mastectomy and Gender Affirmation Surgery, run by Stanford University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 15 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mastectomy, Gender Affirmation Surgery, Nipple Sparing Mastectomy
- What is being tested?
- AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Current steroid use
- Known connective tissue disorder
- Known neuropathy
- Known history of breast cancer
- History of breast radiotherapy
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dung Nguyen, MD, PharmD contact
United States1 site
Division of Plastic & Reconstructive Surgery
Palo Alto, California, 94304
About this study
Official title: The Role of Amnion Membrane Allografts in Nipple Preservation After Nipple Sparing Mastectomy: A Double-Blinded Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Mastectomy, Gender Affirmation Surgery, Nipple Sparing Mastectomy, Prophylactic Mastectomy, Benign Breast Condition
- Being tested
- AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft, Control Device
- Keywords
- nipple sparing mastectomy, gender affirming surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmnioFix dehydrated Human Amnion/Chorion Membrane AllograftDevice
Also called AmnioFix
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 DeviceDevice
Control device will be applied to non-experimental breast. Each patient will serve as their own control.
| Study group | Role | What they receive |
|---|---|---|
| Assess dHACM viability | Experimental | 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. Receives: Device: AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft |
| Assess dHACM effectiveness against control device | Active comparator | 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. Receives: Device: Control Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 3 months post op
Secondary outcomes (5)
Rate of Nipple Healing
Number of nipples that have healed per clinician assessment.
Measured: through study completion, an average of 3 months post op
Degree of nipple loss
Number of nipples partially or wholly lost to necrosis.
Measured: through study completion, an average of 3 months post op
Nipple perfusion
Perfusion of blood in the nipple assessed via indocyanine green (ICG)-SPY technology.
Measured: 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
Participant-rated satisfaction.
Measured: through study completion, an average of 3 months post op
Number of Participants with Nipple Sensation
Participants indicated whether they have nipple sensation (innervation) (Y/N).
Measured: through study completion, an average of 3 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Jun 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dung Nguyen, Stanford University
- Investigators
- Dung Nguyen, MD, PharmD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073808
- Sponsor's protocol ID
- 71564
- Acronym
- AmnioFix
- Status last verified
- Apr 2026
- First submitted
- 9 Sep 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Amnion Membrane Allografts in Nipple Preservation After Nipple Sparing Mastectomy: A Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06073808
- Acronym / sponsor ID
- AmnioFix / 71564
- Conditions
- Mastectomy, Gender Affirmation Surgery, Nipple Sparing Mastectomy, Prophylactic Mastectomy, Benign Breast Condition
- Keywords
- nipple sparing mastectomy, gender affirming surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Assess dHACM viability | Experimental | Device: AmnioFix dehydrated Human Amnion/Chorion Membrane AllograftImplantation 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. |
| Assess dHACM effectiveness against control device | Active comparator | Device: Control DeviceImplantation 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. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- Current steroid use
- Known connective tissue disorder
- Known neuropathy
- Known history of breast cancer
- History of breast radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmnioFix dehydrated Human Amnion/Chorion Membrane AllograftAlso: AmnioFixDehydrated 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. | Device | Assess dHACM viability |
| Control DeviceControl device will be applied to non-experimental breast. Each patient will serve as their own control. | Device | Assess dHACM effectiveness against control device |
Primary outcome
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
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dung Nguyen, MD, PharmD contact
Dung Nguyen, MD, PharmD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft in people with Mastectomy and Gender Affirmation Surgery, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kassandra Carrion (650-498-6004, kcarrion@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.