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Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy (NSM)

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ClinicalTrials.gov Identifier: NCT01796977
Recruitment Status : Terminated (inability to enroll in this subject population)
First Posted : February 22, 2013
Results First Posted : April 7, 2015
Last Update Posted : February 17, 2016
Information provided by (Responsible Party):
Halyard Health

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.

Condition or disease Intervention/treatment
Breast Cancer Reconstructive Breast Surgery Device: OxyGenesys Dissolved Oxygen Dressing Device: Standard Gauze Dressing

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Randomized, Open Label Controlled Trial Using a Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
Study Start Date : December 2012
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 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.
Device: OxyGenesys Dissolved Oxygen Dressing
Placebo Comparator: Standard Gauze Dressing
A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
Device: Standard Gauze Dressing

Primary Outcome Measures :
  1. Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy [ Time Frame: 30 days ]
    Wound Complication Rate

Secondary Outcome Measures :
  1. To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy [ Time Frame: 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").

  2. To Assess Pain Using the Numerical Rating Scale [ Time Frame: 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.

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796977

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
United States, Missouri
St. Louis, Missouri, United States, 63141
United States, New York
Aesthetic Plastic Surgery
Great Neck, New York, United States, 11201
Columbia University
New York, New York, United States, 10032
New York Group
Tarrytown, New York, United States, 10591
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Halyard Health
Study Director: David T Curd, MS Halyard Health

Responsible Party: Halyard Health
ClinicalTrials.gov Identifier: NCT01796977     History of Changes
Other Study ID Numbers: 100-12-0001
First Posted: February 22, 2013    Key Record Dates
Results First Posted: April 7, 2015
Last Update Posted: February 17, 2016
Last Verified: March 2015

Keywords provided by Halyard Health:
Nipple-sparing Mastectomy
Nipple Sparing Mastectomy