Clinical trial NCT01796977: Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
Official title: A Prospective, Multi-Center, Randomized, Open Label Controlled Trial Using a Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Reconstructive Breast Surgery
Keywords: Nipple-sparing Mastectomy
NSM
Nipple Sparing Mastectomy
Lead sponsor: Halyard Health
Sponsor class: INDUSTRY
First posted: 2013-02-22
Enrollment: 27
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy
timeFrame: 30 days
Secondary outcomes:
measure: To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy
timeFrame: 30 days post nipple-sparing mastectomy
measure: To Assess Pain Using the Numerical Rating Scale
timeFrame: 30 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: St. Louis
country: United States
facility: Bodyaesthetic
state: Missouri
city: Great Neck
country: United States
facility: Aesthetic Plastic Surgery
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Tarrytown
country: United States
facility: New York Group
state: New York
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
Study officials:
affiliation: Halyard Health
name: David T Curd, MS
role: STUDY_DIRECTOR
References: