Suspended

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

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What is being tested

OxyGenesys Dissolved Oxygen Dressing

+ Standard Gauze Dressing

Device
Who is being recruted

Breast Diseases+3

+ Neoplasms

+ Neoplasms by Site

Over 21 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: December 2012
See protocol details

Summary

Principal SponsorHalyard Health
Last updated: February 17, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01796977
Principal SponsorHalyard Health
Last updated: February 17, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

27 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms

Criteria

5 inclusion criteria required to participate
At least one breast diagnosed with cancer or mastectomy due to a positive BRCA gene mutation test
Females > 21 years of age
Subject is able to comply with the study protocol
Subject is able to give written consent
Show More Criteria
7 exclusion criteria prevent from participating
Dermabond or other forms of surgical glue is used in the peri-areola region
Inability to perform follow up assessments
Primary tumor(s) located within 2cm of the areola margins
Radiation treatment within 30 days of surgery
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Northwestern University

Chicago, United StatesOpen Northwestern University in Google Maps

University of Chicago

Chicago, United States

Bodyaesthetic

St Louis, United States

Aesthetic Plastic Surgery

Great Neck, United States
Suspended7 Study Centers