Clinical trial · Interventional
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
NCT01796977CI-TRIAL-00020936NSMterminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): inability to enroll in this subject population
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Reconstructive Breast Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | Device | — | UNRESOLVED |
| Standard Gauze Dressing | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- OxyGenesys Dissolved Oxygen Dressing
- description
- OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.
- interventionNames
- Device: OxyGenesys Dissolved Oxygen Dressing
- type
- PLACEBO_COMPARATOR
- label
- Standard Gauze Dressing
- description
- A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
- interventionNames
- Device: Standard Gauze Dressing
Primary outcomes (1)
- measure
- Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.