Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer
| Status: | Withdrawn |
|---|---|
| Conditions: | Breast Cancer, Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2018 |
| Start Date: | October 2018 |
| End Date: | October 2020 |
Return of Breast Sensation Following Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer: An Evaluation of Clinical, Sensory, and Quality of Life Outcomes
Tissue Expander/Implant Reconstruction: The purpose of this study is to determine how and
when nerve sensation to the breast skin returns after mastectomy.
Autologous Tissue Reconstruction: The purpose of this study is to determine whether the
tissue being used to reconstruct your breast can provide sensation by using your own nerves.
Typically all sensation is lost immediately after this type of surgery and returns to varying
degrees. We are hoping to demonstrate that by connecting the two nerves (one from abdomen and
one from the chest wall) together, we can attain meaningful sensation in the transferred
tissues thereby improving your quality of life following surgery.
when nerve sensation to the breast skin returns after mastectomy.
Autologous Tissue Reconstruction: The purpose of this study is to determine whether the
tissue being used to reconstruct your breast can provide sensation by using your own nerves.
Typically all sensation is lost immediately after this type of surgery and returns to varying
degrees. We are hoping to demonstrate that by connecting the two nerves (one from abdomen and
one from the chest wall) together, we can attain meaningful sensation in the transferred
tissues thereby improving your quality of life following surgery.
To determine the timing and distribution of sensation recovery of breast after mastectomy and
breast reconstruction, both with autologous and implant-based reconstruction. Also, to
determine the role of innervated free tissue transfer in breast reconstruction.
Specific Aims
1. Determine the timing and degree of return of breast in women who underwent mastectomy
with autologous tissue or with implant based reconstruction.
2. Determine sensation following neurotized free flap reconstruction
3. Determine whether neurotization has an impact on quality of life measures post
operatively
Study Design Patients will be enrolled prospectively in this data collection study in which
they will receive the standard of care for breast cancer resection and oncologically safe and
accepted means of breast reconstruction with tissue expander and/or prosthetic implants.
Patients will receive additional, non-invasive sensory testing, performed at standard follow
up intervals in clinic by their reconstructive team. All patients participating in the study
will be consented for enrollment at the pre-operative visit by either the surgeon or
physician assistant. As this is a prospective study, all women fitting inclusion criteria
over a 6-month minimal, but projected goal 12-month period will be included.
breast reconstruction, both with autologous and implant-based reconstruction. Also, to
determine the role of innervated free tissue transfer in breast reconstruction.
Specific Aims
1. Determine the timing and degree of return of breast in women who underwent mastectomy
with autologous tissue or with implant based reconstruction.
2. Determine sensation following neurotized free flap reconstruction
3. Determine whether neurotization has an impact on quality of life measures post
operatively
Study Design Patients will be enrolled prospectively in this data collection study in which
they will receive the standard of care for breast cancer resection and oncologically safe and
accepted means of breast reconstruction with tissue expander and/or prosthetic implants.
Patients will receive additional, non-invasive sensory testing, performed at standard follow
up intervals in clinic by their reconstructive team. All patients participating in the study
will be consented for enrollment at the pre-operative visit by either the surgeon or
physician assistant. As this is a prospective study, all women fitting inclusion criteria
over a 6-month minimal, but projected goal 12-month period will be included.
Inclusion Criteria:
- Patients undergoing unilateral or bilateral skin sparing mastectomy for breast cancer
- Patient must have one of the following reconstructions in planned:
- Immediate tissue expander placement
- Immediate implant placement
- Immediate autologous breast reconstruction
- All patients participating in the study must be willing to be consented for enrollment
at the pre-operative visit.
Exclusion Criteria:
- Pre-operative radiation therapy
- Any pre-excising
- Patients with absent or prior damaged nipple areola-complex (NAC) on the "non-surgical
breast"
We found this trial at
1
site
Click here to add this to my saved trials
