Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy (NSM)
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.
Reconstructive Breast Surgery
Device: OxyGenesys Dissolved Oxygen Dressing
Device: Standard Gauze Dressing
|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|
- 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 ]Wound Complication Rate
- To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy [ Time Frame: 30 days post nipple-sparing mastectomy ] [ Designated as safety issue: No ]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").
- To Assess Pain Using the Numerical Rating Scale [ Time Frame: 30 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2012|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796977
|United States, Illinois|
|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|
|New York, New York, United States, 10032|
|New York Group|
|Tarrytown, New York, United States, 10591|
|United States, Texas|
|Dallas, Texas, United States, 75390|
|Study Director:||David T Curd, MS||Halyard Health|