Trial Outcomes & Findings for NPWT PRO vs KCI Ulta® NPWT and to Compare NPWT PRO vs NPWT PRO With Simultaneous Irrigation on Wound Healing (NCT NCT02519621)
NCT ID: NCT02519621
Last Updated: 2023-07-24
Results Overview
Complete healing of wounds as defined by epithelialization with no drainage in three treatment arms: NPWT PRO versus KCI Ulta® NPWT and to Compare NPWT PRO versus NPWT PRO with Simultaneous Irrigation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-07-24
Participant Flow
93 were consented but 3 of them did not have the vac/treatment, so therefore 90 total (30 in each group).
Participant milestones
| Measure |
NPWT PRO Without Irrigation
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage
NPWT PRO without irrigation: NPWT PRO without irrigation.
|
NPWT PRO With Irrigation
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage with simultaneous delivery of topical wound treatment solutions and suspensions over the wound bed (saline irrigant).
NPWT PRO with irrigation: NPWT PRO with irrigation (saline)
|
KCI Ulta NPWT
KCI Ulta NPWT without irrigation.
KCI Ulta: KCI Ulta NPWT without irrigation
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NPWT PRO vs KCI Ulta® NPWT and to Compare NPWT PRO vs NPWT PRO With Simultaneous Irrigation on Wound Healing
Baseline characteristics by cohort
| Measure |
NPWT PRO Without Irrigation
n=30 Participants
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage
NPWT PRO without irrigation: NPWT PRO without irrigation.
|
NPWT PRO With Irrigation
n=30 Participants
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage with simultaneous delivery of topical wound treatment solutions and suspensions over the wound bed (saline irrigant).
NPWT PRO with irrigation: NPWT PRO with irrigation (saline)
|
KCI Ulta NPWT
n=30 Participants
KCI Ulta NPWT without irrigation.
KCI Ulta: KCI Ulta NPWT without irrigation
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.50 years
STANDARD_DEVIATION 9.95 • n=5 Participants
|
53.80 years
STANDARD_DEVIATION 12.21 • n=7 Participants
|
51.70 years
STANDARD_DEVIATION 9.44 • n=5 Participants
|
51.67 years
STANDARD_DEVIATION 10.63 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
30 participants
n=5 Participants
|
90 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksComplete healing of wounds as defined by epithelialization with no drainage in three treatment arms: NPWT PRO versus KCI Ulta® NPWT and to Compare NPWT PRO versus NPWT PRO with Simultaneous Irrigation
Outcome measures
| Measure |
NPWT PRO Without Irrigation
n=30 Participants
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage
NPWT PRO without irrigation: NPWT PRO without irrigation.
|
NPWT PRO With Irrigation
n=30 Participants
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage with simultaneous delivery of topical wound treatment solutions and suspensions over the wound bed (saline irrigant).
NPWT PRO with irrigation: NPWT PRO with irrigation (saline)
|
KCI Ulta NPWT
n=30 Participants
KCI Ulta NPWT without irrigation.
KCI Ulta: KCI Ulta NPWT without irrigation
|
|---|---|---|---|
|
Number of Participants Who Achieved Complete Wound Healing
|
15 Participants
|
19 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 12 weeksNumber of surgeries required to debride infection before wound was ready for closure or coverage.
Outcome measures
| Measure |
NPWT PRO Without Irrigation
n=30 Participants
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage
NPWT PRO without irrigation: NPWT PRO without irrigation.
|
NPWT PRO With Irrigation
n=30 Participants
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage with simultaneous delivery of topical wound treatment solutions and suspensions over the wound bed (saline irrigant).
NPWT PRO with irrigation: NPWT PRO with irrigation (saline)
|
KCI Ulta NPWT
n=30 Participants
KCI Ulta NPWT without irrigation.
KCI Ulta: KCI Ulta NPWT without irrigation
|
|---|---|---|---|
|
Number of Surgeries
|
2.4 surgeries
Standard Deviation 0.77
|
2.0 surgeries
Standard Deviation 0.49
|
2.4 surgeries
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: 12 weeksNumber of days the patient stayed in the hospital
Outcome measures
| Measure |
NPWT PRO Without Irrigation
n=30 Participants
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage
NPWT PRO without irrigation: NPWT PRO without irrigation.
|
NPWT PRO With Irrigation
n=30 Participants
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage with simultaneous delivery of topical wound treatment solutions and suspensions over the wound bed (saline irrigant).
NPWT PRO with irrigation: NPWT PRO with irrigation (saline)
|
KCI Ulta NPWT
n=30 Participants
KCI Ulta NPWT without irrigation.
KCI Ulta: KCI Ulta NPWT without irrigation
|
|---|---|---|---|
|
Length of Stay
|
14.7 days
Standard Deviation 7.4
|
16.3 days
Standard Deviation 15.7
|
15.3 days
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: 12 weeksThe number of days to heal the wound after last surgery was performed.
Outcome measures
| Measure |
NPWT PRO Without Irrigation
n=30 Participants
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage
NPWT PRO without irrigation: NPWT PRO without irrigation.
|
NPWT PRO With Irrigation
n=30 Participants
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage with simultaneous delivery of topical wound treatment solutions and suspensions over the wound bed (saline irrigant).
NPWT PRO with irrigation: NPWT PRO with irrigation (saline)
|
KCI Ulta NPWT
n=30 Participants
KCI Ulta NPWT without irrigation.
KCI Ulta: KCI Ulta NPWT without irrigation
|
|---|---|---|---|
|
Days to Heal
|
41.0 days
Standard Deviation 6.3
|
43.0 days
Standard Deviation 9.4
|
42.0 days
Standard Deviation 13.1
|
Adverse Events
NPWT PRO Without Irrigation
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
NPWT PRO With Irrigation
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
KCI Ulta NPWT
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NPWT PRO Without Irrigation
n=30 participants at risk
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage
NPWT PRO without irrigation: NPWT PRO without irrigation.
|
NPWT PRO With Irrigation
n=30 participants at risk
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage with simultaneous delivery of topical wound treatment solutions and suspensions over the wound bed (saline irrigant).
NPWT PRO with irrigation: NPWT PRO with irrigation (saline)
|
KCI Ulta NPWT
n=30 participants at risk
KCI Ulta NPWT without irrigation.
KCI Ulta: KCI Ulta NPWT without irrigation
|
|---|---|---|---|
|
Infections and infestations
Foot related readmission
|
13.3%
4/30 • Number of events 4 • Adverse events during 12 weeks
|
13.3%
4/30 • Number of events 4 • Adverse events during 12 weeks
|
13.3%
4/30 • Number of events 4 • Adverse events during 12 weeks
|
Other adverse events
| Measure |
NPWT PRO Without Irrigation
n=30 participants at risk
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage
NPWT PRO without irrigation: NPWT PRO without irrigation.
|
NPWT PRO With Irrigation
n=30 participants at risk
Cardinal Health NPWT PRO system (K143016) continuous/intermittent vacuum-assisted drainage with simultaneous delivery of topical wound treatment solutions and suspensions over the wound bed (saline irrigant).
NPWT PRO with irrigation: NPWT PRO with irrigation (saline)
|
KCI Ulta NPWT
n=30 participants at risk
KCI Ulta NPWT without irrigation.
KCI Ulta: KCI Ulta NPWT without irrigation
|
|---|---|---|---|
|
Infections and infestations
Reinfection of study foot
|
13.3%
4/30 • Number of events 4 • Adverse events during 12 weeks
|
16.7%
5/30 • Number of events 5 • Adverse events during 12 weeks
|
16.7%
5/30 • Number of events 5 • Adverse events during 12 weeks
|
Additional Information
Lawrence Lavery, DPM, MPH
UT Southwestern Medical Center at Dallas
Phone: 214-645-0544
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place