Status:
TERMINATED
Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
Lead Sponsor:
Halyard Health
Conditions:
Breast Cancer
Reconstructive Breast Surgery
Eligibility:
FEMALE
21+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01796977
Start Date
December 1 2012
End Date
November 1 2013
Last Update
February 17 2016
Active Locations (7)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
University of Chicago
Chicago, Illinois, United States, 60637
3
Bodyaesthetic
St Louis, Missouri, United States, 63141
4
Aesthetic Plastic Surgery
Great Neck, New York, United States, 11201