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inability to enroll in this subject population
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard Gauze Dressing | Placebo Comparator | A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | Device |
| ||
| Standard Gauze Dressing |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy | Wound Complication Rate | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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"). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David T Curd, MS | Halyard Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| University of Chicago |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 acted as her own control (one breast of each participant was treated with OxyGenesys, while the other breast was treated with the standard dressing (control)). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Each participant acted as her own control - one breast of each participant received the OxyGenesys Dressing, the other breast received the standard dressing. | Posted | Number | breasts | 30 days | breasts | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OxyGenesys Dissolved Oxygen 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. OxyGenesys Dissolved Oxygen Dressing |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| wound necrosis | General disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| epidermolysis | Congenital, familial and genetic disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Halyard Health, Inc. | 470-448-5352 | david.curd@hyh.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Device |
|
| 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. | 30 days |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Bodyaesthetic | St Louis | Missouri | 63141 | United States |
| Aesthetic Plastic Surgery | Great Neck | New York | 11201 | United States |
| Columbia University | New York | New York | 10032 | United States |
| New York Group | Tarrytown | New York | 10591 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
Standard Gauze Dressing
|
|
| 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"). | 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. | Posted | Mean | Standard Deviation | units on a scale | 30 days post nipple-sparing mastectomy |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 30 days |
|
|
|
| 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"). | 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. | Posted | Mean | Full Range | units on a scale | 30 days post nipple-sparing mastectomy |
|
|
|
| 4 |
| 27 |
| 19 |
| 27 |
| EG001 | Standard Gauze Dressing | A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study. Standard Gauze Dressing | 1 | 27 | 7 | 27 |
| cellulitis | Infections and infestations |
|
| debridgement | Surgical and medical procedures |
|
| nausea | Gastrointestinal disorders |
|
| pyrexia | General disorders |
|
| pain | General disorders |
|
| necrosis | General disorders |
|
| cellulitis | Infections and infestations |
|
| wound infection | Infections and infestations |
|
| incision site pruritus | Injury, poisoning and procedural complications |
|
| wound dehiscence | Injury, poisoning and procedural complications |
|
| dizziness | Nervous system disorders |
|
| breast pain | Reproductive system and breast disorders |
|
| scab | Skin and subcutaneous tissue disorders |
|
| ecchymosis | Skin and subcutaneous tissue disorders |
|
| drain removal | Surgical and medical procedures |
|
| seroma | Injury, poisoning and procedural complications |
|
| rash | Skin and subcutaneous tissue disorders |
|
| debridgement | Surgical and medical procedures |
|
| breast hematoma | Reproductive system and breast disorders |
|
| pigmentation disorder | Skin and subcutaneous tissue disorders |
|
| purulent discharge | Infections and infestations |
|
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| D017437 |
| Skin and Connective Tissue Diseases |