Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy

Breast Cancer Clinical Trial

— NSM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01796977
• Other study ID #: 100-12-0001
• Status: Terminated
• Phase: N/A
• First received: January 9, 2013
• Last updated: February 11, 2016
• Start date: December 2012
• Est. completion date: November 2013

Study information

• Verified date: March 2015
• Source: Halyard Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Reconstructive Breast Surgery

Intervention

Device:
• OxyGenesys Dissolved Oxygen Dressing

• Standard Gauze Dressing

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	UT Southwestern	Dallas	Texas
United States	Aesthetic Plastic Surgery	Great Neck	New York
United States	Columbia University	New York	New York
United States	Bodyaesthetic	St. Louis	Missouri
United States	New York Group	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Halyard Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No