Trial Outcomes & Findings for Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy (NCT NCT01796977)
NCT ID: NCT01796977
Last Updated: 2016-02-17
Results Overview
Wound Complication Rate
TERMINATED
NA
27 participants
30 days
2016-02-17
Participant Flow
Participant milestones
| Measure |
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)).
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|---|---|
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Overall Study
STARTED
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27
|
|
Overall Study
COMPLETED
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27
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
Baseline characteristics by cohort
| Measure |
OxyGenesys Dissolved Oxygen Dressing and Gauze Dressing
n=27 Participants
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).
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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26 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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1 Participants
n=5 Participants
|
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Age, Continuous
|
45.01 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
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Sex: Female, Male
Female
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27 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Each participant acted as her own control - one breast of each participant received the OxyGenesys Dressing, the other breast received the standard dressing.
Wound Complication Rate
Outcome measures
| Measure |
OxyGenesys Dissolved Oxygen Dressing
n=27 breasts
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
|
Standard Gauze Dressing
n=27 breasts
A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
Standard Gauze Dressing
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|---|---|---|
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Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy
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5 breasts
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5 breasts
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SECONDARY outcome
Timeframe: 30 days post nipple-sparing mastectomyPopulation: 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.
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").
Outcome measures
| Measure |
OxyGenesys Dissolved Oxygen Dressing
n=25 Participants
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
|
Standard Gauze Dressing
n=26 Participants
A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
Standard Gauze Dressing
|
|---|---|---|
|
To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy
|
19 units on a scale
Standard Deviation 13
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18 units on a scale
Standard Deviation 12
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SECONDARY outcome
Timeframe: 30 daysPopulation: 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.
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.
Outcome measures
| Measure |
OxyGenesys Dissolved Oxygen Dressing
n=26 Participants
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
|
Standard Gauze Dressing
A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
Standard Gauze Dressing
|
|---|---|---|
|
To Assess Pain Using the Numerical Rating Scale
|
0.27 units on a scale
Standard Deviation 0.6
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—
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SECONDARY outcome
Timeframe: 30 days post nipple-sparing mastectomyPopulation: 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.
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").
Outcome measures
| Measure |
OxyGenesys Dissolved Oxygen Dressing
n=25 Participants
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
|
Standard Gauze Dressing
n=26 Participants
A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
Standard Gauze Dressing
|
|---|---|---|
|
To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy
|
19 units on a scale
Interval 6.0 to 51.0
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18 units on a scale
Interval 6.0 to 57.0
|
Adverse Events
OxyGenesys Dissolved Oxygen Dressing
Standard Gauze Dressing
Serious adverse events
| Measure |
OxyGenesys Dissolved Oxygen Dressing
n=27 participants at risk
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
|
Standard Gauze Dressing
n=27 participants at risk
A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
Standard Gauze Dressing
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|---|---|---|
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General disorders
wound necrosis
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11.1%
3/27 • Number of events 3
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0.00%
0/27
|
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Infections and infestations
cellulitis
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3.7%
1/27 • Number of events 1
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0.00%
0/27
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Surgical and medical procedures
debridgement
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0.00%
0/27
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3.7%
1/27 • Number of events 1
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Other adverse events
| Measure |
OxyGenesys Dissolved Oxygen Dressing
n=27 participants at risk
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
|
Standard Gauze Dressing
n=27 participants at risk
A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
Standard Gauze Dressing
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|---|---|---|
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Congenital, familial and genetic disorders
epidermolysis
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11.1%
3/27 • Number of events 3
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3.7%
1/27 • Number of events 1
|
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Gastrointestinal disorders
nausea
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3.7%
1/27 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
General disorders
pyrexia
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3.7%
1/27 • Number of events 1
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3.7%
1/27 • Number of events 1
|
|
General disorders
pain
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3.7%
1/27 • Number of events 1
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3.7%
1/27 • Number of events 1
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General disorders
necrosis
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44.4%
12/27 • Number of events 12
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7.4%
2/27 • Number of events 2
|
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Infections and infestations
cellulitis
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3.7%
1/27 • Number of events 1
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0.00%
0/27
|
|
Infections and infestations
wound infection
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0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Injury, poisoning and procedural complications
incision site pruritus
|
3.7%
1/27 • Number of events 1
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0.00%
0/27
|
|
Injury, poisoning and procedural complications
wound dehiscence
|
3.7%
1/27 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
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Nervous system disorders
dizziness
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3.7%
1/27 • Number of events 1
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3.7%
1/27 • Number of events 1
|
|
Reproductive system and breast disorders
breast pain
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0.00%
0/27
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3.7%
1/27 • Number of events 1
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Skin and subcutaneous tissue disorders
scab
|
3.7%
1/27 • Number of events 1
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0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
ecchymosis
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7.4%
2/27 • Number of events 2
|
11.1%
3/27 • Number of events 3
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Surgical and medical procedures
drain removal
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3.7%
1/27 • Number of events 1
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0.00%
0/27
|
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Injury, poisoning and procedural complications
seroma
|
3.7%
1/27 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
rash
|
3.7%
1/27 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Surgical and medical procedures
debridgement
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Reproductive system and breast disorders
breast hematoma
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3.7%
1/27 • Number of events 1
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0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
pigmentation disorder
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0.00%
0/27
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3.7%
1/27 • Number of events 1
|
|
Infections and infestations
purulent discharge
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3.7%
1/27 • Number of events 1
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0.00%
0/27
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60