Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy

Halyard Health27 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Reconstructive Breast Surgery

Interventions

OxyGenesys Dissolved Oxygen DressingDEVICE

Standard Gauze DressingDEVICE

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (7)

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

Outcomes

Primary Outcomes

Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy

Wound Complication Rate

Time frame: 30 days

Secondary Outcomes

To Evaluate Scar Formation 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").

Time frame: 30 days post nipple-sparing mastectomy

To Assess Pain Using the Numerical Rating Scale

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.

Time frame: 30 days

Data from ClinicalTrials.gov

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