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Clinicaltrials.gov identifier:
NCT04533373
Prevention
Study for people undergoing DIEP flap reconstruction
Study Contact Information:
Josh Puthumana, MD, [email protected]
Carisa M Cooney, MPH, [email protected]
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 flap reconstruction (deep inferior epigastric perforator ).
What the Study Involves
Participants undergoing breast reconstruction will be randomly assigned to one of two groups:
- breast reconstruction with nerve grafting
- 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, [email protected]
Contact: Carisa M Cooney, MPH, [email protected]
- 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 ()
- 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 with radiation
*contact your doctors or the study coordinators for a complete list of exclusion criteria.