Breast Cancer Clinical Trial

Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

27

Study ID:

NCT01796977

Recruitment Status:

Terminated

Sponsor:

Halyard Health

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There are 7 Locations for this study

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Northwestern University
Chicago Illinois, 60611, United States
University of Chicago
Chicago Illinois, 60637, United States
Bodyaesthetic
St. Louis Missouri, 63141, United States
Aesthetic Plastic Surgery
Great Neck New York, 11201, United States
Columbia University
New York New York, 10032, United States
New York Group
Tarrytown New York, 10591, United States
UT Southwestern
Dallas Texas, 75390, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

27

Study ID:

NCT01796977

Recruitment Status:

Terminated

Sponsor:


Halyard Health

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