A Prospective, Multi-Center, Randomized, Open Label Controlled Trial Using a Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
This study will recruit women who are undergoing a bilateral mastectomy for either cancer or
a positive BRCA gene. Women will be randomized to a different treatment per breast. One
breast will receive the OxyGenesys dressing and the other will receive the standard gauze
dressing. The study will evaluate wound complication rates and compare the two treatments.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the effects of OxyGenesys Dissolved Oxygen Dressing in wound complication rates of the nipple areolar complex post nipple-sparing mastectomy
30 days
No
United States: Food and Drug Administration
100-12-0001
NCT01796977
December 2012
January 2014
Name | Location |
---|---|
Columbia University | New York, New York 10032-3784 |
Northwestern University | Chicago, Illinois 60611 |
University of Chicago | Chicago, Illinois 60637 |
UT Southwestern | Dallas, Texas 75390 |
Bodyaesthetic | St. Louis, Missouri 63141 |
Aesthetic Plastic Surgery | Great Neck, New York 11201 |
New York Group | Tarrytown, New York 10591 |