Restoring Sensation after DIEP Flap Reconstruction

About the Study

The goal of this study is to look at how well a nerve graft works for improving sensation to the reconstructed breast after mastectomy in people undergoing DIEP flap reconstruction (deep inferior epigastric perforator flap). 

What the Study Involves

Participants undergoing breast reconstruction will be randomly assigned to one of two groups:

1. DIEP breast reconstruction with nerve grafting
2. DIEP flap breast reconstruction without nerve grafting

The primary outcome will be measurement of breast sensation at 12 months. The study team will use a device which measures changes in sensation and assesses return of sensory, grip and pinch function, by touching probes to the area of interest and getting a report on nerve function. Other outcomes will be measurement of breast sensation at 6, 18, and 24 months and quality of life at 6, 12, 18, and 24 months.

Study Site

Maryland
Baltimore, MD
Johns Hopkins Hospital
Contact: Josh Puthumana, MD, jputhum2@jhmi.edu   
Contact: Carisa M Cooney, MPH, ccooney3@jhmi.edu

• All patients presenting to Johns Hopkins who have had or will have mastectomy and are planning to undergo unilateral mastectomy followed by breast reconstruction with autologous deep inferior epigastric perforator flap (DIEP) 
• 18 years of age and older

*contact your doctors or the study coordinators for a complete list of inclusion criteria. 

The following people are not able to participate in this study

• any patient with; diabetic neuropathy, thyroid disorders, collagen vascular disease, alcoholism, pernicious anemia, or any other severe underlying peripheral neuropathy including chemotherapy-induced neuropathy or neuropathy induced by other medications.
• pregnant or lactating
• people with recurrent breast cancer
• people who had previous reconstructive procedures or who have previously undergone lumpectomy with radiation

*contact your doctors or the study coordinators for a complete list of exclusion criteria.