Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts
Trial ID or NCT#
Status
RECRUITING
Purpose
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.
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
Eligibility 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.
- - 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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Shannon Meyer
650-724-1953
View on ClinicalTrials.gov
