Trial Outcomes & Findings for Evaluation of a Novel Post-Surgical Dressing (NCT NCT01831596)
NCT ID: NCT01831596
Last Updated: 2024-11-25
Results Overview
Frequency of complaints about device use and operation
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
30 days
Results posted on
2024-11-25
Participant Flow
Participant milestones
| Measure |
ciSNaP
SNaP disposable, mechanically powered Negative Pressure Wound Therapy System
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
ciSNaP
SNaP disposable, mechanically powered Negative Pressure Wound Therapy System
|
|---|---|
|
Overall Study
Other
|
8
|
Baseline Characteristics
Evaluation of a Novel Post-Surgical Dressing
Baseline characteristics by cohort
| Measure |
ciSNaP
n=51 Participants
SNaP disposable, mechanically powered Negative Pressure Wound Therapy System
|
|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity (White)
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity (Non-White)
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: The study was terminated by Spiracur. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Frequency of complaints about device use and operation
Outcome measures
Outcome data not reported
Adverse Events
ciSNaP
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ciSNaP
n=51 participants at risk
SNaP disposable, mechanically powered Negative Pressure Wound Therapy System
|
|---|---|
|
Skin and subcutaneous tissue disorders
Blister
|
3.9%
2/51 • Number of events 2 • 30 Days
|
|
Infections and infestations
Mild surgical infection
|
3.9%
2/51 • Number of events 2 • 30 Days
|
|
Cardiac disorders
Congestive Heart Failure exacerbation
|
2.0%
1/51 • Number of events 1 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Stitch granuloma
|
5.9%
3/51 • Number of events 3 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Minor dehiscence
|
5.9%
3/51 • Number of events 3 • 30 Days
|
|
Blood and lymphatic system disorders
Hemarthrosis
|
2.0%
1/51 • Number of events 1 • 30 Days
|
|
Blood and lymphatic system disorders
Lymphocele
|
2.0%
1/51 • Number of events 1 • 30 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place