Trial record 15 of 87 for:    Open Studies | mastectomy

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

This study is currently recruiting participants.
Verified May 2013 by Kimberly-Clark Corporation
Sponsor:
Information provided by (Responsible Party):
Kimberly-Clark Corporation
ClinicalTrials.gov Identifier:
NCT01796977
First received: January 9, 2013
Last updated: May 10, 2013
Last verified: May 2013
  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.


Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796977

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Danielle Troyer    773-702-6302    dtroyer@surgery.bsd.uchicago.edu   
Principal Investigator: David Song, MD         
Sub-Investigator: Julie Park, MD         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Jessica Gaido    312-695-5670    jgaido29@gmail.com   
Principal Investigator: John YS Kim, MD         
Sub-Investigator: Neil Fine, MD         
United States, Missouri
Bodyaesthetic Recruiting
St. Louis, Missouri, United States, 63141
Contact: Niki Buettner    314-628-8200    nbuettner@bodyaesthetic.com   
Principal Investigator: Leroy Young, MD         
Sub-Investigator: CB Boswell, MD         
United States, New York
Aesthetic Plastic Surgery Recruiting
Great Neck, New York, United States, 11201
Contact: Eva Bersin, PA    516-498-8400    ebersin@bodyplasticsx.com   
Principal Investigator: Ron Isreali, MD         
Columbia University Not yet recruiting
New York, New York, United States, 10032
Contact: Amiya Vaz    212-305-1317    av2454@columbia.edu   
Principal Investigator: Sheldon Feldman, MD         
New York Group Not yet recruiting
Tarrytown, New York, United States, 10591
Principal Investigator: Andrew Salzberg, MD         
United States, Texas
UT Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Jessica Harper    214-645-3967    jessica.harper@utsouthwestern.edu   
Principal Investigator: Sumeet Teotia, MD         
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 10, 2013
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 April 16, 2014