Breast Cancer
Conditions
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.
Interventions
DEVICENACgraft
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.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Grafts With Complete Healing | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NACgraft Patients Patients requiring reconstruction of their nipple and areola have a NACgraft surgically implanted on their breasts. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | NACgraft Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 6 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 6 |
| other Total, other adverse events | 2 / 6 |
| serious Total, serious adverse events | 1 / 6 |
Outcome results
Primary
Number of Grafts With Complete Healing
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.
Time frame: 3, 6 and 12 months
Population: Participant who complete the protocol
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| NACgraft patients | Number of Grafts With Complete Healing | 3 months | 8 grafts |
| NACgraft patients | Number of Grafts With Complete Healing | 6 months | 8 grafts |
| NACgraft patients | Number of Grafts With Complete Healing | 12 months | 8 grafts |