Print

Restoring Sensation after DIEP Flap Reconstruction

https://www.facingourrisk.org/research-clinical-trials/study/217/restoring-sensation-after-diep-flap-reconstruction

Clinicaltrials.gov identifier:
NCT04533373 (https://clinicaltrials.gov/show/NCT04533373)

Prevention
Study for people undergoing DIEP flap reconstruction

Study Contact Information:

Josh Puthumana, MD, [email protected] 

Carisa M Cooney, MPH, [email protected]


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, [email protected]   
Contact: Carisa M Cooney, MPH, [email protected]

 

 


This Study is Open To:

 

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

 

This Study is Not Open To:

The following people are not able to participate in this study

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

 


About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.