Trial Outcomes & Findings for Negative Pressure Wound Therapy to Reduce Surgical Site Infection (NCT NCT01905397)
NCT ID: NCT01905397
Last Updated: 2022-12-02
Results Overview
Number and percentage of participants with at least 1 surgical site infection (SSI).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
164 participants
Primary outcome timeframe
30 days after surgery; assessed at 4-5 days and 30 days post-operation
Results posted on
2022-12-02
Participant Flow
Subjects were enrolled at Duke University Medical Center from December 18, 2013 to April 8, 2021 and at Indiana University from December 12, 2016 to April 8, 2021.
Participant milestones
| Measure |
Negative Pressure Wound Therapy
The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure.
|
Conventional Wound Therapy
Sterile bandages and dressings.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
82
|
|
Overall Study
COMPLETED
|
63
|
75
|
|
Overall Study
NOT COMPLETED
|
19
|
7
|
Reasons for withdrawal
| Measure |
Negative Pressure Wound Therapy
The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure.
|
Conventional Wound Therapy
Sterile bandages and dressings.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Surgery canceled/aborted
|
9
|
5
|
|
Overall Study
Incision < 7 cm
|
2
|
0
|
|
Overall Study
Wrong treatment
|
1
|
1
|
|
Overall Study
Device not applied
|
3
|
0
|
|
Overall Study
Dressing not applied in operating room
|
1
|
0
|
|
Overall Study
Wound vac turned off due to device alarm
|
1
|
0
|
Baseline Characteristics
Negative Pressure Wound Therapy to Reduce Surgical Site Infection
Baseline characteristics by cohort
| Measure |
Negative Pressure Wound Therapy
n=82 Participants
The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure.
|
Conventional Wound Therapy
n=82 Participants
Sterile bandages and dressings.
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days after surgery; assessed at 4-5 days and 30 days post-operationPopulation: Participants who completed the study.
Number and percentage of participants with at least 1 surgical site infection (SSI).
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=63 Participants
The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure.
|
Conventional Wound Therapy
n=75 Participants
Sterile bandages and dressings.
|
|---|---|---|
|
Participants With a Surgical Site Infection
|
14 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 30 days post-surgeryEach surgical site infection was classified into one of the following categories: superficial incisional, deep incisional, or organ/space (as defined by The American College of Surgeons NSQIP \[National Surgical Quality Improvement Program\] guidelines). The number of infections in each category is reported separately for both treatment arms. Some participants had multiple infections.
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=16 infections
The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure.
|
Conventional Wound Therapy
n=23 infections
Sterile bandages and dressings.
|
|---|---|---|
|
Number of Surgical Site Infections by Type
Deep Incisional
|
2 infections
|
6 infections
|
|
Number of Surgical Site Infections by Type
Superficial Incisional
|
7 infections
|
7 infections
|
|
Number of Surgical Site Infections by Type
Organ/Space
|
7 infections
|
10 infections
|
SECONDARY outcome
Timeframe: Up to 62 days post-surgeryAssess (or compare) the length of hospital stay between subjects who receive standard of care and incisional V.A.C. via PIMS.
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=63 Participants
The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure.
|
Conventional Wound Therapy
n=75 Participants
Sterile bandages and dressings.
|
|---|---|---|
|
Length of Hospital Stay
|
8 days
Interval 3.0 to 46.0
|
6 days
Interval 3.0 to 62.0
|
Adverse Events
Negative Pressure Wound Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Conventional Wound Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Negative Pressure Wound Therapy
n=63 participants at risk
The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure.
|
Conventional Wound Therapy
n=75 participants at risk
Sterile bandages and dressings.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash, Grade 2
|
1.6%
1/63 • Number of events 1 • 30 days after surgery
|
0.00%
0/75 • 30 days after surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place