Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy

Not Applicable

Terminated

Interventions: Device: Standard Gauze Dressing
Device: OxyGenesys Dissolved Oxygen Dressing

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 the OxyGenesys dressing and the other will receive the standard gauze dressing. The study will evaluate wound complication rates and compare the two treatments.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Standard Gauze Dressing	Standard Gauze Dressing	A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
OxyGenesys Dissolved Oxygen Dressing	OxyGenesys Dissolved Oxygen Dressing	OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.

Primary Outcome Measures

Name	Time	Method
Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy	30 days	Wound Complication Rate

Secondary Outcome Measures

Name	Time	Method
To Assess Pain Using the Numerical Rating Scale	30 days	Numerical Rating Scale (NRS) - range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable". The means of these scores and their respective standard deviations are reported for each study group.
To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy	30 days post nipple-sparing mastectomy	Patient and Observer Scar Assessment Scale - range = 1 - 10. "1" is best condition ("normal skin") and "10" is worst condition ("worst scar imaginable"). The scale is used to assess each of six different wound characteristics, including vascularity, pigmentation, thickness, relief, pliability, and surface area. The means of these combined scores and their respective standard deviations are reported for each study group. The range of the final evaluation score, based on the collective evaluation of each of the six wound characteristics is "6" (if each of the six scores equals "1") to "60" (if each of the six scores equals "10").

Locations (7): University of Chicago
🇺🇸
Chicago, Illinois, United States
Northwestern University
🇺🇸
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
UT Southwestern
🇺🇸
Dallas, Texas, United States
New York Group
🇺🇸
Tarrytown, New York, United States