Breast Cancer, Reconstructive Breast Surgery
Conditions
Keywords
Nipple-sparing Mastectomy, NSM, Nipple Sparing Mastectomy
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.
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.
Interventions
Sponsors
Halyard Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy | 30 days | Wound Complication Rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy | 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). |
| To Assess Pain Using the Numerical Rating Scale | 30 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OxyGenesys Dissolved Oxygen Dressing and Gauze Dressing OxyGenesys 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: A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
Each study participant was supposed to act as her own control (one breast to be treated with the test article, the other breast with the control article). | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | OxyGenesys Dissolved Oxygen Dressing and Gauze Dressing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous | 45.01 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 27 | 7 / 27 |
| serious Total, serious adverse events | 4 / 27 | 1 / 27 |
Outcome results
Primary
Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy
Wound Complication Rate
Time frame: 30 days
Population: Each participant acted as her own control - one breast of each participant received the OxyGenesys Dressing, the other breast received the standard dressing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy | 5 breasts |
| Standard Gauze Dressing | Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy | 5 breasts |
Secondary
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.
Time frame: 30 days
Population: There is just one NRS value calculated for the indicated time-frame, and thus a comparison between study groups with respect to this outcome was not made. The single NRS value at 30 days is reported here. One patient did not provide follow-up data at this time-point, and thus the total number of participants is 26 instead of 27 for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | To Assess Pain Using the Numerical Rating Scale | 0.27 units on a scale | Standard Deviation 0.6 |
Secondary
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).
Time frame: 30 days post nipple-sparing mastectomy
Population: Each participant acted as her own control - one breast received OxyGenesys, while the other breast received the standard dressing. Two patients in the OxyGenesys study arm, and one patient in the Control study arm did not provide follow-up data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy | 19 units on a scale | Standard Deviation 13 |
| Standard Gauze Dressing | To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy | 18 units on a scale | Standard Deviation 12 |
Secondary
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).
Time frame: 30 days post nipple-sparing mastectomy
Population: Each participant acted as her own control - one breast received OxyGenesys, while the other breast received the standard dressing. Two patients in the OxyGenesys study arm, and one patient in the Control study arm did not provide follow-up data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy | 19 units on a scale |
| Standard Gauze Dressing | To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy | 18 units on a scale |