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

This study has been terminated.
(inability to enroll in this subject population)
Sponsor:
Information provided by (Responsible Party):
Kimberly-Clark Corporation
ClinicalTrials.gov Identifier:
NCT01796977
First received: January 9, 2013
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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 Intervention
Breast Cancer
Reconstructive Breast Surgery
Device: OxyGenesys Dissolved Oxygen Dressing
Device: Standard Gauze Dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Kimberly-Clark Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate scar formation 30 days post nipple-sparing mastectomy [ Time Frame: 30 days post nipple-sparing mastectomy ] [ Designated as safety issue: No ]
  • To assess pain using the numeric rating scale [ Time Frame: 48 hours, 6 days, 14 days and 30 days ] [ Designated as safety issue: No ]
  • To evaluate the overall adverse events during study participation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Serious adverse events will be followed to closure.


Enrollment: 20
Study Start Date: December 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796977

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Northwestern University
Chicago, Illinois, United States, 60611
United States, Missouri
Bodyaesthetic
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
Kimberly-Clark Corporation
  More Information

No publications provided

Responsible Party: Kimberly-Clark Corporation
ClinicalTrials.gov Identifier: NCT01796977     History of Changes
Other Study ID Numbers: 100-12-0001
Study First Received: January 9, 2013
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Kimberly-Clark Corporation:
Nipple-sparing Mastectomy
NSM
Nipple Sparing Mastectomy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 19, 2014