Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts

A Single Arm, Single Center Pilot Study Evaluating the Safety and Healing Time of a Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Graft

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: NACgraft

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shannon Meyer; Phone Number: 650-724-1953; Email: smeyer27@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Recruiting
      • Stanford University
      • Contact: Shannon Meyer; Phone Number: 650-724-1953; Email: smeyer27@stanford.edu
      • Principal Investigator: Geoffrey C Geoffrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NACgraft patients; uni- or bilateral engraftment surgery will be performed	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to healing of implanted NACgraft	Time to healing for each NACgraft will be as the first weekly visit at which the surgeon and central reviewer deem the graft >99% epithelialized. This measurement will be reported as the number of weeks to healing. Degree of healing will be based on visual assessment by the surgeon and central reviewer with the following metrics on a visual analog scale (VAS): epithelialization (0-100%); granulation (0-100%); overall healing (0-100%). Photographs will be taken using a standardized 3d imaging device, stored and transmitted securely to a central reviewer for independent review. Time to complete healing will be defined as the first visit at which the surgeon and independent reviewer determine that there is >99% epithelialization of the graft.	14 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Geoffrey C Gurtner, Stanford Universiy

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB-55153; BRS0117 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes