A Prospective, Multi-Center, Randomized, Open Label Controlled Trial Using a Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
21 Years
N/A
Female
Breast Cancer, Reconstructive Breast Surgery
Trial Information
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.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluate the effects of OxyGenesys Dissolved Oxygen Dressing in wound complication rates of the nipple areolar complex post nipple-sparing mastectomy
Outcome Time Frame:
30 days
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
100-12-0001
NCT ID:
NCT01796977
Start Date:
December 2012
Completion Date:
January 2014
Related Keywords:
- Breast Cancer
- Reconstructive Breast Surgery
- Nipple-sparing Mastectomy
- NSM
- Nipple Sparing Mastectomy
- Breast Neoplasms
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 |
