Trial record 1 of 1 for:
Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts.
Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts
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ClinicalTrials.gov Identifier: NCT04534010 |
Recruitment Status :
Not yet recruiting
First Posted : September 1, 2020
Last Update Posted : September 1, 2020
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Sponsor:
Stanford University
Information provided by (Responsible Party):
Geoffrey C. Gurtner, Stanford University
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Device: NACgraft | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Estimated Study Start Date : | October 15, 2020 |
Estimated Primary Completion Date : | December 15, 2021 |
Estimated Study Completion Date : | December 15, 2022 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Plastic and Cosmetic Surgery
Arm | Intervention/treatment |
---|---|
Experimental: NACgraft patients |
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. |
Primary Outcome Measures :
- Time to healing of implanted NACgraft [ Time Frame: 14 months ]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.
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.
No Contacts or Locations Provided
Responsible Party: | Geoffrey C. Gurtner, Professor, Stanford University |
ClinicalTrials.gov Identifier: | NCT04534010 |
Other Study ID Numbers: |
IRB-55153 |
First Posted: | September 1, 2020 Key Record Dates |
Last Update Posted: | September 1, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |