Trial Outcomes & Findings for PROphylactic Wound VACuum Therapy to Decrease Rates of Cesarean Section in the Obese Population (NCT NCT02128997)
NCT ID: NCT02128997
Last Updated: 2017-10-13
Results Overview
The primary outcome variable was a composite of wound morbidity at 4 weeks postpartum including SSI and/or wound opening
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
136 participants
Primary outcome timeframe
Four weeks after cesarean section
Results posted on
2017-10-13
Participant Flow
Participant milestones
| Measure |
Closed Incision Wound Vacuum (Prevena)
Closed incision wound vacuum (Prevena)
Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision
|
Routine Wound Care
This arm includes patients having a cesarean section with routine wound care
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
69
|
|
Overall Study
COMPLETED
|
61
|
58
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
Reasons for withdrawal
| Measure |
Closed Incision Wound Vacuum (Prevena)
Closed incision wound vacuum (Prevena)
Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision
|
Routine Wound Care
This arm includes patients having a cesarean section with routine wound care
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
11
|
Baseline Characteristics
This population only includes patients who were not lost to follow up.
Baseline characteristics by cohort
| Measure |
Closed Incision Wound Vacuum (Prevena)
n=67 Participants
Closed incision wound vacuum (Prevena)
Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision
|
Routine Wound Care
n=69 Participants
This arm includes patients having a cesarean section with routine wound care
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27 Years
STANDARD_DEVIATION 5 • n=58 Participants • This population only includes patients who were not lost to follow up.
|
29 Years
STANDARD_DEVIATION 3 • n=58 Participants • This population only includes patients who were not lost to follow up.
|
28 Years
STANDARD_DEVIATION 4 • n=116 Participants • This population only includes patients who were not lost to follow up.
|
|
Sex: Female, Male
Female
|
67 Participants
n=67 Participants
|
69 Participants
n=69 Participants
|
136 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=67 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=61 Participants • This population only includes patients who were not lost to follow up.
|
0 Participants
n=58 Participants • This population only includes patients who were not lost to follow up.
|
0 Participants
n=119 Participants • This population only includes patients who were not lost to follow up.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=61 Participants • This population only includes patients who were not lost to follow up.
|
1 Participants
n=58 Participants • This population only includes patients who were not lost to follow up.
|
1 Participants
n=119 Participants • This population only includes patients who were not lost to follow up.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=61 Participants • This population only includes patients who were not lost to follow up.
|
0 Participants
n=58 Participants • This population only includes patients who were not lost to follow up.
|
1 Participants
n=119 Participants • This population only includes patients who were not lost to follow up.
|
|
Race (NIH/OMB)
Black or African American
|
46 Participants
n=61 Participants • This population only includes patients who were not lost to follow up.
|
45 Participants
n=58 Participants • This population only includes patients who were not lost to follow up.
|
91 Participants
n=119 Participants • This population only includes patients who were not lost to follow up.
|
|
Race (NIH/OMB)
White
|
14 Participants
n=61 Participants • This population only includes patients who were not lost to follow up.
|
12 Participants
n=58 Participants • This population only includes patients who were not lost to follow up.
|
26 Participants
n=119 Participants • This population only includes patients who were not lost to follow up.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=61 Participants • This population only includes patients who were not lost to follow up.
|
0 Participants
n=58 Participants • This population only includes patients who were not lost to follow up.
|
0 Participants
n=119 Participants • This population only includes patients who were not lost to follow up.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=61 Participants • This population only includes patients who were not lost to follow up.
|
0 Participants
n=58 Participants • This population only includes patients who were not lost to follow up.
|
0 Participants
n=119 Participants • This population only includes patients who were not lost to follow up.
|
|
Region of Enrollment
United States
|
67 participants
n=67 Participants
|
69 participants
n=69 Participants
|
136 participants
n=136 Participants
|
PRIMARY outcome
Timeframe: Four weeks after cesarean sectionThe primary outcome variable was a composite of wound morbidity at 4 weeks postpartum including SSI and/or wound opening
Outcome measures
| Measure |
Closed Incision Wound Vacuum (Prevena)
n=61 Participants
Closed incision wound vacuum (Prevena)
Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision
|
Routine Wound Care
n=58 Participants
This arm includes patients having a cesarean section with routine wound care
|
|---|---|---|
|
Number of Participants With Wound Complications
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Postpartum day 2On postoperative day 2, all patients were administered a pain scale: Rank sharp pain (0-10), 10 being worst possible sharp pain.
Outcome measures
| Measure |
Closed Incision Wound Vacuum (Prevena)
n=61 Participants
Closed incision wound vacuum (Prevena)
Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision
|
Routine Wound Care
n=58 Participants
This arm includes patients having a cesarean section with routine wound care
|
|---|---|---|
|
Pain Scores
|
6 Unit on a scale
Interval 4.0 to 8.0
|
5.5 Unit on a scale
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: Postpartum day 2On postoperative day 2, all patients were administered a pain scale: Rank tingling pain (0-10), 10 being worst possible tingling pain
Outcome measures
| Measure |
Closed Incision Wound Vacuum (Prevena)
n=61 Participants
Closed incision wound vacuum (Prevena)
Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision
|
Routine Wound Care
n=58 Participants
This arm includes patients having a cesarean section with routine wound care
|
|---|---|---|
|
Tingling Pain Scores
|
2 Unit on a scale
Interval 0.0 to 6.0
|
1.5 Unit on a scale
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: Until hospital discharge and then for 4 weeks follow upOutcome measures
| Measure |
Closed Incision Wound Vacuum (Prevena)
n=61 Participants
Closed incision wound vacuum (Prevena)
Closed incision wound vacuum (Prevena): wound vacuum to be placed on a closed incision
|
Routine Wound Care
n=58 Participants
This arm includes patients having a cesarean section with routine wound care
|
|---|---|---|
|
Postpartum Length of Stay
|
3 days
Interval 3.0 to 4.0
|
3 days
Interval 3.0 to 4.0
|
Adverse Events
Closed Incision Wound Vacuum (Prevena)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Routine Wound Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place