Trial Outcomes & Findings for A Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients (NCT NCT02399111)
NCT ID: NCT02399111
Last Updated: 2016-11-21
Results Overview
This study was terminated prior to gathering of data.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
30 days
Results posted on
2016-11-21
Participant Flow
Participant milestones
| Measure |
Not Obese:BMI<30; Standard Care
Not obese: BMI\< 30; Standard Wound Care
|
Obese:BMI≥30; Standard Care
Obese: BMI ≥30; Standard Wound Care
|
Not Obese:BMI<30; Wound Vac
Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period.
|
Obese:BMI≥30; Wound Vac
Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
4
|
0
|
|
Overall Study
COMPLETED
|
4
|
1
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients
Baseline characteristics by cohort
| Measure |
Not Obese:BMI<30; Standard Care
n=4 Participants
Not obese:BMI\<30;Standard Wound Care
|
Obese:BMI≥30; Standard Care
n=1 Participants
Obese:BMI≥30;Standard Wound Care
|
Not Obese:BMI<30; Wound Vac
n=4 Participants
Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period.
|
Obese:BMI≥30; Wound Vac
Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Gender
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Gender
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 30 daysThis study was terminated prior to gathering of data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysThis study was terminated prior to collection of data.
Outcome measures
Outcome data not reported
Adverse Events
Not Obese:BMI<30; Standard Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Obese:BMI≥30; Standard Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Not Obese:BMI<30; Wound Vac
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese:BMI≥30; Wound Vac
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Not Obese:BMI<30; Standard Care
n=4 participants at risk
Not obese:BMI\<30;Standard Wound Care
|
Obese:BMI≥30; Standard Care
n=1 participants at risk
Obese:BMI≥30;Standard Wound Care
|
Not Obese:BMI<30; Wound Vac
n=4 participants at risk
Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period.
|
Obese:BMI≥30; Wound Vac
Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period.
|
|---|---|---|---|---|
|
Infections and infestations
Infection
|
25.0%
1/4 • Number of events 1
|
100.0%
1/1 • Number of events 1
|
0.00%
0/4
|
—
0/0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place