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Trial record 1 of 1 for:    Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts.
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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 : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
Geoffrey C. Gurtner, Stanford University

Study Description
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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 Design
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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 : April 15, 2021
Estimated Primary Completion Date : April 15, 2022
Estimated Study Completion Date : April 15, 2023

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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: March 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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