Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Halyard Health
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.
Age
21–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Subject is able to give written consent
Females \>21 years of age
At least one breast diagnosed with cancer or mastectomy due to a positive BRCA gene mutation test.
Subject is indicated for bilateral nipple-sparing mastectomy surgery with immediate breast reconstruction
Subject is able to comply with the study protocol
You may not be if
Primary tumor(s) located within 2cm of the areola margins
Inability to perform follow up assessments
Radiation treatment within 30 days of surgery
Dermabond or other forms of surgical glue is used in the peri-areola region
Subjects who are known to be allergic to any of the test product(s) or any component of the test product(s)
Women who are pregnant
Subjects who have been treated with an investigational drug or device within the past 30 days prior to enrollment
Clareo Health | Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
