Breast CancerNSMNCT01796977
Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
A study testing OxyGenesys Dissolved Oxygen Dressing and Standard Gauze Dressing in people with Breast Cancer and Reconstructive Breast Surgery, run by Halyard Health at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer, Reconstructive Breast Surgery
- What is being tested?
- OxyGenesys Dissolved Oxygen Dressing and Standard Gauze Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
UT Southwestern
Dallas, Texas, 75390
Aesthetic Plastic Surgery
Great Neck, New York, 11201
Columbia University
New York, New York, 10032
Bodyaesthetic
St Louis, Missouri, 63141
New York Group
Tarrytown, New York, 10591
About this study
Official title: A Prospective, Multi-Center, Randomized, Open Label Controlled Trial Using a Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
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.
Read the detailed 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.
- Conditions
- Breast Cancer, Reconstructive Breast Surgery
- Being tested
- OxyGenesys Dissolved Oxygen Dressing, Standard Gauze Dressing
- Keywords
- Nipple-sparing Mastectomy, NSM, Nipple Sparing Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxyGenesys Dissolved Oxygen DressingDevice
Standard Gauze DressingDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Standard Gauze Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy
Wound Complication Rate
Measured: 30 days
Secondary outcomes (2)
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").
Measured: 30 days post nipple-sparing mastectomy
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: inability to enroll in this subject population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halyard Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David T Curd, MS, Study director, Halyard Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796977
- Sponsor's protocol ID
- 100-12-0001
- Acronym
- NSM
- Status last verified
- Mar 2015
- First submitted
- 9 Jan 2013
- Last updated
- 17 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Randomized, Open Label Controlled Trial Using a Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
- ClinicalTrials.gov ID
- NCT01796977
- Acronym / sponsor ID
- NSM / 100-12-0001
- Conditions
- Breast Cancer, Reconstructive Breast Surgery
- Keywords
- Nipple-sparing Mastectomy, NSM, Nipple Sparing Mastectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inability to enroll in this subject population
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Halyard HealthIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Posted 7 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | Active comparator | Device: OxyGenesys Dissolved Oxygen DressingOxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds. |
| Standard Gauze Dressing | Placebo comparator | Device: Standard Gauze DressingA sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | Device | OxyGenesys Dissolved Oxygen Dressing |
| Standard Gauze Dressing | Device | Standard Gauze Dressing |
Primary outcome
Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy
Time frame: 30 days
Wound Complication Rate
2 secondary outcomes
To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy
Time frame: 30 days post nipple-sparing mastectomy
To Assess Pain Using the Numerical Rating Scale
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David T Curd, MS study director
Halyard Health
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OxyGenesys Dissolved Oxygen Dressing and Standard Gauze Dressing in people with Breast Cancer and Reconstructive Breast Surgery, run by Halyard Health at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016; AzTrials last refreshed its copy on 26 Oct 2026.