A Single Arm, Single Center Pilot Study Evaluating the Safety and Healing Time of a Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Graft
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Stanford University
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Number of Grafts With Complete Healing
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Number of Grafts With Complete Healing
Time Frame: 3, 6 and 12 months
Complete is defined as when the graft is \>99% epithelialized. 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Arash Momeni
Assistant Professor of Surgery
Stanford University