Breast Reconstruction Clinical Trial
Official title:
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
NCT number | NCT03135392 |
Other study ID # | CASE2117 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2018 |
Est. completion date | October 2020 |
Verified date | November 2018 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2020 |
Est. primary completion date | October 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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" |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite measure of sensation | Differences of at least 20% comparing control to experimental breasts would be clinically meaningful. Composite measure will be calculated by combining the follow binomial factors: detection of temperature difference (feeling hot and cold), detection of sharp versus dull pressure, detection of vibration, discerning point pressure | Up to 24 months after surgery | |
Secondary | Quality of Life as measured by a 19-question survey regarding sensation and appearance of breast. | A total of 19 Likert scale questions will be given to participants in the pre- and post-Surgical Sensation Questionnaire regarding sensation and appearance of breast before and after reconstruction. | Up to 24 months after surgery |
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