Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer

Withdrawn before enrolling · Not applicable

Conditions studied: Mastectomy, Breast Reconstruction

In brief

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.

Key facts

Study ID: NCT03135392
Run by: Case Comprehensive Cancer Center
People needed: 0
Starts: 2018-10-01
Expected to finish: 2020-10-01
Last updated by the study team: 2018-11-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Pre-operative radiation therapy
Any pre-excising
Patients with absent or prior damaged nipple areola-complex (NAC) on the "non-surgical breast"

Where it is running

Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.