Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Multi-Center, Randomized, Open Label Controlled Trial Using a Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy

Conditions
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Breast Cancer, Reconstructive Breast Surgery

Intervention / Treatment
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* Device: OxyGenesys Dissolved Oxygen Dressing
* Device: Standard Gauze Dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OxyGenesys Dissolved Oxygen Dressing<br>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<br> <br> |
| Placebo Comparator: Standard Gauze Dressing<br>A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study. | Device: Standard Gauze Dressing<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy | Wound Complication Rate | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nipple-sparing Mastectomy, NSM, Nipple Sparing Mastectomy