Trial Outcomes & Findings for Single-Use Negative Pressure Wound Therapy for Free Flap Donor Sites (NCT NCT03340025)
NCT ID: NCT03340025
Last Updated: 2021-07-30
Results Overview
Comparison of photographs of all participants' wounds taken at post-operative Day 5, post-operative Day 14-21, and post-operative Day 30. Percentage skin graft take will be evaluated on Day 30 by blinded, independent raters. A 10x10 grid was digitally overlain on each image. The de-identified images were randomized and given to two independent raters. The raters used three criteria to assess each graft. Overall graft appearance was graded on a 1-5 scale, percent of graft take was estimated, and the presence of exposed tendon was noted for each timepoint.
COMPLETED
NA
20 participants
Baseline through 30 days
2021-07-30
Participant Flow
Participant milestones
| Measure |
Negative Pressure Wound Therapy
PICO Single Use Negative Pressure Wound Therapy System
PICO Single Use Negative Pressure Wound Therapy System: Class II negative pressure wound therapy powered suction pump
|
Conventional Dressing
traditional surgical wound dressing of xeroform gauze and padding
xeroform gauze: traditional surgical dressing of xeroform gauze and padding
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Negative Pressure Wound Therapy
PICO Single Use Negative Pressure Wound Therapy System
PICO Single Use Negative Pressure Wound Therapy System: Class II negative pressure wound therapy powered suction pump
|
Conventional Dressing
traditional surgical wound dressing of xeroform gauze and padding
xeroform gauze: traditional surgical dressing of xeroform gauze and padding
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Single-Use Negative Pressure Wound Therapy for Free Flap Donor Sites
Baseline characteristics by cohort
| Measure |
Negative Pressure Wound Therapy
n=11 Participants
PICO Single Use Negative Pressure Wound Therapy System
PICO Single Use Negative Pressure Wound Therapy System: Class II negative pressure wound therapy powered suction pump
|
Conventional Dressing
n=9 Participants
traditional surgical wound dressing of xeroform gauze and padding
xeroform gauze: traditional surgical dressing of xeroform gauze and padding
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through 30 daysComparison of photographs of all participants' wounds taken at post-operative Day 5, post-operative Day 14-21, and post-operative Day 30. Percentage skin graft take will be evaluated on Day 30 by blinded, independent raters. A 10x10 grid was digitally overlain on each image. The de-identified images were randomized and given to two independent raters. The raters used three criteria to assess each graft. Overall graft appearance was graded on a 1-5 scale, percent of graft take was estimated, and the presence of exposed tendon was noted for each timepoint.
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=9 Participants
PICO Single Use Negative Pressure Wound Therapy System
PICO Single Use Negative Pressure Wound Therapy System: Class II negative pressure wound therapy powered suction pump
|
Conventional Dressing
n=7 Participants
traditional surgical wound dressing of xeroform gauze and padding
xeroform gauze: traditional surgical dressing of xeroform gauze and padding
|
|---|---|---|
|
Progression of Wound Healing
|
69.9 percentage of skin graft take
Interval 50.0 to 90.0
|
75.6 percentage of skin graft take
Interval 55.0 to 95.0
|
Adverse Events
Negative Pressure Wound Therapy
Conventional Dressing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Benjamin Greene, MD
University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place