Trial Outcomes & Findings for SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds (NCT NCT00951080)
NCT ID: NCT00951080
Last Updated: 2022-08-01
Results Overview
The percent change in wound area as measured from Visitrak tracings (Value at 16 weeks minus value at baseline / value at baseline)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
Baseline and 16 weeks
Results posted on
2022-08-01
Participant Flow
Participant milestones
| Measure |
SNaP Wound Care System
SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
|
Traditional NPWT System
Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
68
|
|
Overall Study
COMPLETED
|
38
|
41
|
|
Overall Study
NOT COMPLETED
|
26
|
27
|
Reasons for withdrawal
| Measure |
SNaP Wound Care System
SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
|
Traditional NPWT System
Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
4
|
1
|
|
Overall Study
Other
|
19
|
22
|
Baseline Characteristics
SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
Baseline characteristics by cohort
| Measure |
SNaP Wound Care System
n=64 Participants
SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
|
Traditional NPWT System
n=68 Participants
Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.0 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 15.6 • n=7 Participants
|
65.3 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity (White)
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
20 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
68 participants
n=7 Participants
|
132 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 16 weeksThe percent change in wound area as measured from Visitrak tracings (Value at 16 weeks minus value at baseline / value at baseline)
Outcome measures
| Measure |
SNaP Wound Care System
n=59 Participants
SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
|
Traditional NPWT System
n=56 Participants
Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
|
|---|---|---|
|
Percent Change in Wound Area
|
-85.7 percentage of baseline wound area
Interval -100.0 to 392.3
|
-94 percentage of baseline wound area
Interval -100.0 to 500.0
|
Adverse Events
SNaP Wound Care System
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Traditional NPWT System
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SNaP Wound Care System
n=64 participants at risk
SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
|
Traditional NPWT System
n=68 participants at risk
Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
|
|---|---|---|
|
Infections and infestations
Infection of study wound (Venous Leg Ulcer)
|
0.00%
0/64
|
1.5%
1/68
|
|
Infections and infestations
Cellulitis right foot (Venous Leg Ulcer)
|
0.00%
0/64
|
1.5%
1/68
|
Other adverse events
| Measure |
SNaP Wound Care System
n=64 participants at risk
SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
|
Traditional NPWT System
n=68 participants at risk
Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Maceration
|
15.6%
10/64
|
19.1%
13/68
|
|
Skin and subcutaneous tissue disorders
Allergic reaction to dressing
|
6.2%
4/64
|
7.4%
5/68
|
|
General disorders
Pain (wound)
|
1.6%
1/64
|
5.9%
4/68
|
|
Skin and subcutaneous tissue disorders
Blisters
|
4.7%
3/64
|
5.9%
4/68
|
|
Infections and infestations
Infection
|
3.1%
2/64
|
7.4%
5/68
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place