Breast Cancer, Breast Reconstruction, Nipple Reconstruction
Conditions
Keywords
Biodesign, Nipple Reconstruction, Breast Cancer, Mastectomy
Brief summary
Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK Biodesign® Nipple Reconstruction Cylinder.
Interventions
DEVICENipple reconstruction
Biodesign® Nipple Reconstruction Cylinder
Sponsors
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient presents with a history of breast cancer, having previously completed either uni- or bi-lateral breast removal and reconstruction. * Patient presents with a desire to obtain nipple reconstruction * Patient is at least 18 years of age * And other inclusion criteria
Exclusion criteria
* Patient is not medically fit enough for surgery under local anesthesia * Patient is currently smoking, using tobacco products, or nicotine products (i.e. patch, gum, or nasal spray) * Patient is pregnant, breastfeeding or planning further pregnancy during the study period * Patient has physical allergies or cultural objections to the receipt of porcine products * And other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure) | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Patient Satisfaction | 12 months | Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nipple Reconstruction Cylinder Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Unanticipated chemo for breast cancer | 2 |
Baseline characteristics
| Characteristic | Nipple Reconstruction Cylinder |
|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 8.7 |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 50 |
| serious Total, serious adverse events | 1 / 50 |
Outcome results
Primary
Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)
Time frame: 12 months
Population: There were two patients (three nipples) without plastic surgery matrix in place at 12MO.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nipple Reconstruction Cylinder | Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure) | 37.3 percentage of projection vs baseline | Standard Deviation 17.5 |
Secondary
Rate of Patient Satisfaction
Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nipple Reconstruction Cylinder | Rate of Patient Satisfaction | 97.8 percentage of patients |