Post Surgical Wound
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of the Closed-Incision SNaP Device.
Interventions
DEVICEciSNaP
SNaP disposable, mechanically powered Negative Pressure Wound Therapy System
Sponsors
3M
KCI USA, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Surgically closed incision. * Subject is 18 years of age or older. * Subject consents to follow-up per protocol. * Willing and able to sign informed consent.
Exclusion criteria
* Subject is allergic to wound care products used in this study. * Subject has wounds with exposed blood vessels not suitable for negative pressure therapy. * Pregnant or pregnancy-suspected subject. * Subject actively participating in other clinical trials that conflict with the current study. * Subject is unable or unwilling to comply with protocol requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Complaints About Device Use and Operation | 30 days | Frequency of complaints about device use and operation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ciSNaP SNaP disposable, mechanically powered Negative Pressure Wound Therapy System | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other | 8 |
Baseline characteristics
| Characteristic | ciSNaP |
|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 11.8 |
| Race/Ethnicity, Customized Ethnicity (Non-White) | 10 Participants |
| Race/Ethnicity, Customized Ethnicity (White) | 41 Participants |
| Region of Enrollment United States | 51 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 6 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
Frequency of Complaints About Device Use and Operation
Frequency of complaints about device use and operation
Time frame: 30 days
Population: The study was terminated by Spiracur. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.