Trials / Terminated
TerminatedNCT01796977
Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
A Prospective, Multi-Center, Randomized, Open Label Controlled Trial Using a Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Halyard Health · Industry
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OxyGenesys Dissolved Oxygen Dressing | |
| DEVICE | Standard Gauze Dressing |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
- First posted
- 2013-02-22
- Last updated
- 2016-02-17
- Results posted
- 2015-04-07
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01796977. Inclusion in this directory is not an endorsement.