About this trial
During breast surgery, sensory nerves are cut which may lead to reduced sensation and pain. Surgical reinnervation techniques have been developed with the aim of improving postoperative sensation by preserving the nerves and connecting them to the nipple and areola. The investigators aim to compare postoperative sensation and patient reported outcomes in patients undergoing reinnervation versus those not undergoing reinnervation to determine if there is a difference. The investigators will investigate this in patients undergoing gender-affirming mastectomy, implant-based breast reconstruction and autologous breast reconstruction. The investigators will use various tools that measure sensation quantitatively.
Eligibility criteria
Qualifiers
Age over 18
Patient is scheduled for gender mastectomy surgery (including nipple sparing mastectomy and mastectomy with free nipple graft) or NSM with breast implant or autologous reconstruction
Patient is capable and willing to provide informed consent
Disqualifiers
Patient has a nerve condition that does not allow for assessment of sensation
Any subject who at the discretion of the Investigator is not suitable for inclusion in the study or is unlikely to comply with follow-up schedule
Currently prescribed medication known to impact nerve regeneration or to cause peripheral neuropathy
Bilateral reconstruction with non-uniform treatment (i.e. 1 reconstructed breast is non-neurotized, 1 reconstructed breast is neurotized)
Trial design
Treatments tested in this trial
- Sensory testing
Treatment groups
Sponsors and collaborators
Weill Medical College of Cornell University
Lead sponsor
Massachusetts General Hospital
Collaborator