Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy

Stopped early · Not applicable

Conditions studied: Breast Cancer, Reconstructive Breast Surgery

In brief

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.

Key facts

Study ID: NCT01796977
Run by: Halyard Health
People needed: 27
Starts: 2012-12-01
Expected to finish: 2013-11-01
Last updated by the study team: 2016-02-17

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

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

Full record on ClinicalTrials.gov

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