Trial Outcomes & Findings for A Randomized Clinical Trial Evaluating Negative Pressure Therapy to Decrease Vascular Groin Incision Complications (NCT NCT02581904)
NCT ID: NCT02581904
Last Updated: 2026-02-25
Results Overview
Composite measure including wound dehiscence (skin or fascia), lymph leak (seroma or fistula), infection (deep or superficial), or hematoma
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
140 participants
Primary outcome timeframe
30 days
Results posted on
2026-02-25
Participant Flow
Participant milestones
| Measure |
Low Risk - Dry Gauze Dressing Care
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
|
High Risk - Prevena Care
The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
Prevena Care: The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
|
High Risk - Dry Gauze Dressing Care
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
59
|
60
|
|
Overall Study
COMPLETED
|
21
|
59
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Clinical Trial Evaluating Negative Pressure Therapy to Decrease Vascular Groin Incision Complications
Baseline characteristics by cohort
| Measure |
High Risk - Dry Gauze Dressing Care
n=60 Participants
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
|
Low Risk - Dry Gauze Dressing Care
n=21 Participants
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
|
Total
n=140 Participants
Total of all reporting groups
|
High Risk - Prevena Care
n=59 Participants
The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
Prevena Care: The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
55 Participants
n=565 Participants
|
27 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
85 Participants
n=565 Participants
|
32 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
63 Participants
n=565 Participants
|
34 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
77 Participants
n=565 Participants
|
25 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=20 Participants
|
21 participants
n=40 Participants
|
140 participants
n=565 Participants
|
59 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 30 daysComposite measure including wound dehiscence (skin or fascia), lymph leak (seroma or fistula), infection (deep or superficial), or hematoma
Outcome measures
| Measure |
High Risk - Prevena Care
n=59 Participants
The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
Prevena Care: The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
|
High Risk - Dry Gauze Dressing Care
n=60 Participants
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
|
Low Risk - Dry Gauze Dressing Care
n=21 Participants
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
|
|---|---|---|---|
|
Groin Wound Complication
|
6 Participants
|
19 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysReadmission to inpatient hospital for management of wound complications
Outcome measures
| Measure |
High Risk - Prevena Care
n=59 Participants
The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
Prevena Care: The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
|
High Risk - Dry Gauze Dressing Care
n=60 Participants
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
|
Low Risk - Dry Gauze Dressing Care
n=21 Participants
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
|
|---|---|---|---|
|
Hospital Length of Stay
|
10.6 days
Standard Deviation 12.2
|
10.6 days
Standard Deviation 8.6
|
3.8 days
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 30 daysReturn to operating room for surgical management of wound complications
Outcome measures
| Measure |
High Risk - Prevena Care
n=59 Participants
The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
Prevena Care: The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
|
High Risk - Dry Gauze Dressing Care
n=60 Participants
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
|
Low Risk - Dry Gauze Dressing Care
n=21 Participants
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
|
|---|---|---|---|
|
Return to Operating Room
|
5 Participants
|
11 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysReadmission for wound complication
Outcome measures
| Measure |
High Risk - Prevena Care
n=59 Participants
The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
Prevena Care: The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
|
High Risk - Dry Gauze Dressing Care
n=60 Participants
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
|
Low Risk - Dry Gauze Dressing Care
n=21 Participants
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
|
|---|---|---|---|
|
Hospital Readmission
|
4 Participants
|
10 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysIndex Hospital Cost
Outcome measures
| Measure |
High Risk - Prevena Care
n=59 Participants
The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
Prevena Care: The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
|
High Risk - Dry Gauze Dressing Care
n=60 Participants
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
|
Low Risk - Dry Gauze Dressing Care
n=21 Participants
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
|
|---|---|---|---|
|
Index Hospital Cost
|
29,2952 USD
Standard Deviation 29,320
|
30,678 USD
Standard Deviation 23,338
|
17,549 USD
Standard Deviation 13,403
|
Adverse Events
High Risk - Prevena Care
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
High Risk - Dry Gauze Dressing Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Low Risk - Dry Gauze Dressing Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Risk - Prevena Care
n=59 participants at risk
The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
Prevena Care: The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
|
High Risk - Dry Gauze Dressing Care
n=60 participants at risk
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
|
Low Risk - Dry Gauze Dressing Care
n=21 participants at risk
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
|
|---|---|---|---|
|
Vascular disorders
PAD Bypass Graft Thrombosis
|
3.4%
2/59
|
1.7%
1/60
|
0.00%
0/21
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place