Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-11-30

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.

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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.

Conditions

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Breast Cancer Reconstructive Breast Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

OxyGenesys Dissolved Oxygen Dressing

Intervention Type DEVICE

Standard Gauze Dressing

A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.

Group Type PLACEBO_COMPARATOR

Standard Gauze Dressing

Intervention Type DEVICE

Interventions

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OxyGenesys Dissolved Oxygen Dressing

Intervention Type DEVICE

Standard Gauze Dressing

Intervention Type DEVICE

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

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No