NCT01796977

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 7, 2015

Completed
Last Updated

February 17, 2016

Status Verified

March 1, 2015

Enrollment Period

11 months

First QC Date

January 9, 2013

Results QC Date

March 26, 2015

Last Update Submit

February 11, 2016

Conditions

Breast CancerReconstructive Breast Surgery

Keywords

Nipple-sparing MastectomyNSMNipple Sparing Mastectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy

    30 days post nipple-sparing mastectomy

  • To Assess Pain Using the Numerical Rating Scale

    30 days

Study Arms (2)

OxyGenesys Dissolved Oxygen Dressing

ACTIVE COMPARATOR

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

Standard Gauze Dressing

PLACEBO COMPARATOR

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

Device: Standard Gauze Dressing

Interventions

OxyGenesys Dissolved Oxygen DressingDEVICE
OxyGenesys Dissolved Oxygen Dressing
Standard Gauze DressingDEVICE
Standard Gauze Dressing

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Bodyaesthetic

St Louis, Missouri, 63141, United States

Location

Aesthetic Plastic Surgery

Great Neck, New York, 11201, United States

Location

Columbia University

New York, New York, 10032, United States

Location

New York Group

Tarrytown, New York, 10591, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Director of Clinical Affairs
Organization
Halyard Health, Inc.
david.curd@hyh.com
470-448-5352

Study Officials

  • David T Curd, MS

    Halyard Health

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2013

First Posted

February 22, 2013

Study Start

December 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

February 17, 2016

Results First Posted

April 7, 2015

Record last verified: 2015-03

Locations

US(7)