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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft for nipple preservation in mastectomy?

Research shows that amnion/chorion membranes, like AmnioFix, help in tissue repair and reduce scar tissue formation in various medical procedures, such as craniectomies and chronic ulcers, suggesting potential benefits for nipple preservation in mastectomy. ^{1 2 3 4 5}

Is the amnion membrane allograft generally safe for use in humans?

Research shows that the amnion membrane allograft, used in various medical fields, has been applied safely without adverse events in cases like chronic wound healing and eye surgeries. It is considered safe and easy to use, with no reported safety issues in the studies reviewed. ^{1 2 6 7 8}

How is the AmnioFix treatment for nipple preservation in mastectomy different from other treatments?

AmnioFix uses a dehydrated human amnion/chorion membrane, which is unique because it promotes tissue repair and regeneration without causing rejection, making it a novel option for preserving nipple tissue during mastectomy. ^{1 5 9 10 11}

What is the purpose of this 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.

Research Team

Dung H Nguyen, MD, PharmD

Principal Investigator

Stanford University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Colombia pubmed.ncbi.nlm.nih.gov

Healing of a chronic ulcer of the lower limb of venous origin with fresh human amniochorionic membrane allograft [2023]

2. England pubmed.ncbi.nlm.nih.gov

Cryopreserved amniotic membrane in the treatment of limb skin defects of aplasia cutis congenita: a case study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Dehydrated human amnion/chorion membrane use in emergent craniectomies shows minimal dural adhesions. [2023]

4. United States 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. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Human amniotic membrane for myocutaneous dehiscence after a radical surgical treatment of vulvar cancer: A case report. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Amniotic membrane in ophthalmology: properties, preparation, storage and indications for grafting-a review. [2022]

7. England 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Placental-based allograft use for tissue regeneration and scar prevention for neurosurgical wounds. [2022]

9. China pubmed.ncbi.nlm.nih.gov

[The advances in the application of amniotic membrane stroma in promoting tissue repair]. [2006]

10. England pubmed.ncbi.nlm.nih.gov

Amniotic membrane grafts, "fresh" or frozen? A clinical and in vitro comparison. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Dried Amniotic Membrane on Wound Healing at Split-Thickness Skin Graft Donor Sites: A Randomized, Placebo-Controlled, Double-blind Trial. [2021]