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


N/A
21 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Reconstructive Breast Surgery

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the effects of OxyGenesys Dissolved Oxygen Dressing in wound complication rates of the nipple areolar complex post nipple-sparing mastectomy

Outcome Time Frame:

30 days

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

100-12-0001

NCT ID:

NCT01796977

Start Date:

December 2012

Completion Date:

January 2014

Related Keywords:

  • Breast Cancer
  • Reconstructive Breast Surgery
  • Nipple-sparing Mastectomy
  • NSM
  • Nipple Sparing Mastectomy
  • Breast Neoplasms

Name

Location

Columbia UniversityNew York, New York  10032-3784
Northwestern UniversityChicago, Illinois  60611
University of ChicagoChicago, Illinois  60637
UT SouthwesternDallas, Texas  75390
BodyaestheticSt. Louis, Missouri  63141
Aesthetic Plastic SurgeryGreat Neck, New York  11201
New York GroupTarrytown, New York  10591