Spots Global Cancer Trial Database for Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
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Trial Identification
Brief Title: Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
Official Title: A Prospective, Multi-Center, Randomized, Open Label Controlled Trial Using a Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
Study ID: NCT01796977
Study Description
Brief Summary: This study will evaluate the effect of OxyGenesys Dissolved Oxygen Dressing in wound complication rates of the nipple areolar complex after a nipple sparing mastectomy.
Detailed Description: 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.
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Northwestern University, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Bodyaesthetic, St. Louis, Missouri, United States
Aesthetic Plastic Surgery, Great Neck, New York, United States
Columbia University, New York, New York, United States
New York Group, Tarrytown, New York, United States
UT Southwestern, Dallas, Texas, United States
Contact Details
Name: David T Curd, MS
Affiliation: Halyard Health
Role: STUDY_DIRECTOR
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