Amnion Membrane Allograft for Nipple Preservation in Mastectomy

(AmnioFix Trial)

Overseen By Dung Nguyen, MD, PharmD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Steroids

Disqualifiers: Breast cancer, Radiotherapy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special tissue membrane, called dehydrated human amnion/chorion membrane (dHACM), can protect the nipple area during a type of breast surgery. The focus is on individuals undergoing nipple-sparing mastectomy (NSM), a surgery often performed to prevent breast cancer. Participants will receive either the dHACM (known as AmnioFix) or a control device to determine which better maintains nipple area health. This trial may suit biological females planning this surgery for breast cancer prevention or as part of gender-affirming surgery. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve surgical outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using steroids.

What prior data suggests that the AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft is safe for nipple preservation in mastectomy?

Research has shown that dehydrated human amnion/chorion membrane (dHACM) allografts, such as AmnioFix, are generally safe for people. These membranes aid in healing wounds, particularly in patients with chronic wounds and lower body injuries. While specific data on using dHACM for preserving nipples during mastectomies is not yet available, its use in other treatments suggests it is likely safe. However, more research is needed to confirm this for mastectomy patients. Some studies have reported mixed results regarding its safety and effectiveness in surgical wounds, so this should be considered. Overall, dHACM has been used in various medical situations, indicating a level of safety for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft because it offers a novel approach to preserving the nipple during mastectomy procedures. Unlike traditional methods that rely on surgical techniques alone, this treatment uses a bioactive tissue graft derived from the amniotic membrane, which is known for its healing properties and ability to reduce inflammation. The unique biological composition of the membrane may promote better healing and tissue integration, potentially improving outcomes for patients undergoing nipple-sparing mastectomies. This could lead to enhanced cosmetic results and faster recovery times compared to current surgical options.

What evidence suggests that this trial's treatments could be effective for NAC preservation in nipple sparing mastectomy?

Studies have shown that amnion/chorion membranes, such as AmnioFix, aid in tissue repair and reduce scar tissue formation. This is particularly beneficial in surgeries and other medical procedures requiring healing. Research indicates that these membranes enhance healing and decrease complication rates. Although no study has specifically examined preserving the nipple after a mastectomy with this treatment, success in other wound healing types is promising. In this trial, participants will receive either the AmnioFix allograft or a control device during nipple-sparing mastectomy. The treatment creates a supportive environment with growth factors that enhance tissue healing. This makes AmnioFix a promising option for potentially improving nipple survival after surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Dung H Nguyen, MD, PharmD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for biological females aged 15-75 who are undergoing nipple sparing mastectomy (NSM) due to gender dysphoria or nonmalignant breast conditions. It's not open to those with a history of breast cancer, past breast radiotherapy, current pregnancy or nursing, steroid use, connective tissue disorders, or neuropathy.

Inclusion Criteria

I am a transgender male, diagnosed with gender dysphoria, wanting surgery, and am 15 or older.

I am a woman aged 18-75 wanting preventive breast surgery.

Exclusion Criteria

I have a history of breast cancer.

I have had radiation therapy for breast cancer.

Pregnant or nursing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implantation of dHACM or control device during Nipple Sparing Mastectomy

Surgical procedure

1 visit (in-person)

Follow-up

Participants are monitored for nipple viability, perfusion, sensation, and aesthetic satisfaction

3 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft
• Control Device

Trial Overview The study tests if dehydrated human amnion/chorion membrane allografts (dHACMs), which aid wound healing in other contexts, can improve the viability of the nipple-areola complex after NSM. Participants will be randomly assigned to receive dHACMs or a control device during surgery.

How Is the Trial Designed?

Group I: Assess dHACM viability Experimental Treatment 1 Intervention

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.

Group II: Assess dHACM effectiveness against control device Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

In a case series of five patients with chronic non-healing wounds, the use of dehydrated human amnion/chorion membrane allograft resulted in a significant mean area reduction of 43% at 3 weeks, with complete healing achieved in a median time of 64 days.

The treatment was safe, with no adverse events reported, and was easy to administer, indicating that dehydrated amnion/chorion membrane allograft could be an effective option for patients whose wounds have not responded to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amniotic membrane is a potential regenerative option for chronic non-healing wounds: a report of five cases receiving dehydrated human amnion/chorion membrane allograft. Mrugala, A., Sui, A., Plummer, M., et al.[2021]

A fresh human placental membrane allograft was successfully used to heal a chronic venous ulcer in an 89-year-old woman, demonstrating its potential effectiveness in treating long-standing wounds.

After 60 days of treatment, the ulcer was completely healed, indicating that the amniochorionic membrane can be a viable therapeutic option for chronic vascular ulcers that do not respond to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healing of a chronic ulcer of the lower limb of venous origin with fresh human amniochorionic membrane allograft Piamo, A., García, M., Romero, D., et al.[2023]

In a study involving 43 patients, the use of human amnion-chorion membranes for alveolar ridge preservation showed no significant difference in bone vitality or dimensions compared to collagen membranes, indicating both are effective options.

After an average healing period of 19.5 weeks, neither membrane type compromised ridge dimensions or bone vitality, suggesting that intentional exposure of the membranes does not negatively impact the healing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes in Alveolar Ridge Preservation: A Clinical and Histological Study. Faraj, SA., Kutkut, A., Taylor, RC., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-mastectomy-9-2023-a8248

Amnion Membrane Allograft for Nipple Preservation in ... Research shows that amnion/chorion membranes, like AmnioFix, help in tissue repair and reduce scar tissue formation in various medical procedures, such as ...

2. ctv.veeva.com ctv.veeva.com/study/the-role-of-amnion-membrane-allografts-in-nipple-preservation

The Role of Amnion Membrane Allografts in Nipple Preservation The overall objective of this proposal is to conduct a randomized-controlled study to determine whether treatment with dehydrated human ...

3. smartpatients.com smartpatients.com/trials/NCT06073808

The Role of Amnion Membrane Allografts in Nipple ... A randomized-controlled study to determine whether treatment with dehydrated human amnion/chorion membrane (dHACMs) allografts can improve NAC viability.

4. sigma.larvol.com sigma.larvol.com/product.php?e1=781998&tab=newstrac

AmnioFix (dehydrated human amnion/chorion membrane ... Amniofix and other dHACM (dehydrated human amniotic/chorionic membrane) therapies reported faster and complete healing with lower complication rates, when ...

5. mimedx.com mimedx.com/amniofix/

AMNIOFIX AMNIOFIX is a tissue allograft composed of dehydrated human amnion/chorion membrane (DHACM). It is available in sheet, fenestrated, and wrap configurations.

6. delta.larvol.com delta.larvol.com/Products/?ProductId=1149dd77-1033-4b8c-8aa3-ae9e7d6e4969

AmnioFix (dehydrated human amnion/chorion membrane ... Dehydrated Human Amnion/Chorion Membrane (DHACM) to Protect Against Anastomotic Leaks in Patients Undergoing a Low Anterior Resection Without Protective ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34609611/

Dehydrated human amnion/chorion membrane allografts ... The purpose of this study is to review the potential of dHACM to facilitate post-surgical and myelomeningocele wound repair. A comprehensive ...

8. ldh.la.gov ldh.la.gov/assets/medicaid/MCPP/5.2.23/222_UHC_skin_soft_tissue_substitutes_LA_cs1_Redline.pdf

Skin and Soft Tissue Substitutes (for Louisiana Only) An ECRI report for AmnioFix Amnion/Chorion Membrane Allograft (MiMedx) for Treating. Surgical Wounds indicates that the evidence for AmnioFix is inconclusive.