Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts

NCT ID: NCT04534010

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-28
• Study Completion Date: 2024-11-21

Brief Summary

The goal of this study is to evaluate safety and healing time after nipple-areolar complex (NAC) reconstruction with the BioAesthetics' decellularized human nipple-areolar complex (dcl-hNAC) graft in patients who have had autologous breast reconstruction for breast cancer. Secondary objectives will be to assess patient satisfaction, patient well-being, patient self-esteem, patient body image, patient psychological well-being, nipple dimensions and sensitivity following NAC reconstruction surgery with the BioAesthetics' dcl-hNAC graft.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NACgraft patients

uni- or bilateral engraftment surgery will be performed

Group Type: EXPERIMENTAL

NACgraft

Intervention Type: DEVICE

Patients requiring reconstruction of their nipple and areola have a NACgraft surgically implanted on their breasts. A NACgraft is a novel decellularized cadaveric implant derived from human nipples.

Interventions

NACgraft

Patients requiring reconstruction of their nipple and areola have a NACgraft surgically implanted on their breasts. A NACgraft is a novel decellularized cadaveric implant derived from human nipples.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient age 18-65
• Patient desires NAC grafting ≥3 months after autologous breast reconstruction
• Patient agrees to sleep on back until grafts healed (6 weeks)
• Patient agrees to abstain from aspirin, alcohol, or excessive caffeine until grafts healed (6 weeks)
• Patient agrees to not undergo NAC tattooing until completing study (12 months)
• Patient is able to understand and willing to sign informed consent.

Exclusion Criteria

• History of delayed wound healing
• history of Vitamin C deficiency
• history of diabetes (Type I or Type II)
• current BMI<18.5 or >40 kg/m,
• patient has any other uncontrolled comorbidity.
• Patient has a history of allergic reaction to any decellularized biologic matrix product.
• Patient is currently smoking or using tobacco or nicotine products (i.e. patch, gum, or nasal spray) or has used such products in the past 12 months.
• Patient is currently receiving radiation or chemotherapy or received radiation to the breast wall.
• Patient has a history of prior NAC reconstruction
• Patient has had NAC tattooing.
• Patient is pregnant, breastfeeding or planning to become pregnant during the study period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Arash Momeni

Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geoffrey C Gurtner

Role: PRINCIPAL_INVESTIGATOR

Stanford Universiy

Locations

Stanford University

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BRS0117

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-55153

Identifier Type: -

Identifier Source: org_study_id