Status:
WITHDRAWN
Effect of Neurotization on QoL and Sensory Restoration
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Breast Reconstruction
Neurotization
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a single-site, randomized, double-blinded trial to assess whether neurotization following autologous breast reconstruction in patients with breast cancer increases quality of life and sensatio...
Detailed Description
In 2019, nearly one third of cancers diagnosed in the United States were breast cancers. Per the Plastic Surgery procedural statistics from the American Society of Plastic Surgery database, that same ...
Eligibility Criteria
Inclusion
- Willing to provide informed consent
- The patient is ≥ 18 years
- Patients presenting to UW Health who have had or will have unilateral or bilateral mastectomy (therapeutic or prophylactic) and are planning to undergo autologous reconstruction with TRAM/DIEP will be included
Exclusion
- Patient is non-English speaking
- Patient is known or believed to be pregnant
- Patient is a minor (individuals \<18 years old)
- Patient is a prisoner
- Individuals unable to give consent due to another condition such as impaired decision-making capacity
- Autologous reconstruction where the flap is buried (e.g. there is no autologous skin exposed for sensation testing)
- Patient is a male
- Any patient with: diabetic neuropathy, thyroid disorders, collagen vascular disease, alcoholism, pernicious anemia, or any other severe underlying peripheral neuropathy
- Women with recurrent breast cancer
- Women who have undergone previous breast reconstructive procedures
- Not suitable for study participation due to other reasons at the discretion of the investigators
- Patient is currently lactating
- History of radiation therapy
- Patient undergoing a latissimus dorsi flap for reconstruction
- Patient undergoing alloplastic reconstruction
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05206565
Start Date
March 1 2025
End Date
February 1 2027
Last Update
January 9 2025
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