Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04534010
• Other study ID #: IRB-55153
• Secondary ID: BRS0117
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 28, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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