Trial Outcomes & Findings for Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications (NCT NCT02461433)
NCT ID: NCT02461433
Last Updated: 2019-02-26
Results Overview
The incidence of postoperative surgical site infection (according to National Healthcare Safety Network - Center for Disease Control guidelines) in open surgery
TERMINATED
NA
2 participants
Up to 7 days postop
2019-02-26
Participant Flow
Participant milestones
| Measure |
Prevena
After surgery this group will receive the Prevena device (negative pressure wound therapy).
Prevena: Prevena Incision Management system
|
Standard Dressing
After surgery this group will receive standard of care dressings on their surgical wound.
Standard Dressing: This involves standard of care dressing including but not limited to gauze.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications
Baseline characteristics by cohort
| Measure |
Prevena
n=1 Participants
After surgery this group will receive the Prevena device (negative pressure wound therapy).
Prevena: Prevena Incision Management system
|
Standard Dressing
n=1 Participants
After surgery this group will receive standard of care dressings on their surgical wound.
Standard Dressing: This involves standard of care dressing including but not limited to gauze.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
n=99 Participants
|
45 years
n=107 Participants
|
39.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days postopThe incidence of postoperative surgical site infection (according to National Healthcare Safety Network - Center for Disease Control guidelines) in open surgery
Outcome measures
| Measure |
Prevena
n=1 Participants
After surgery this group will receive the Prevena device (negative pressure wound therapy).
Prevena: Prevena Incision Management system
|
Standard Dressing
n=1 Participants
After surgery this group will receive standard of care dressings on their surgical wound.
Standard Dressing: This involves standard of care dressing including but not limited to gauze.
|
|---|---|---|
|
Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines
|
0 Surgical Site infections
|
0 Surgical Site infections
|
SECONDARY outcome
Timeframe: Up to 14 days postopDehiscence, seroma and hematoma. Reported as number of aggregate events.
Outcome measures
| Measure |
Prevena
n=1 Participants
After surgery this group will receive the Prevena device (negative pressure wound therapy).
Prevena: Prevena Incision Management system
|
Standard Dressing
n=1 Participants
After surgery this group will receive standard of care dressings on their surgical wound.
Standard Dressing: This involves standard of care dressing including but not limited to gauze.
|
|---|---|---|
|
Other Wound Complications (Aggregate)
|
0 aggregate wound complication events
|
0 aggregate wound complication events
|
SECONDARY outcome
Timeframe: Up to 7 days postopPopulation: The samples were not sent to the lab
Skin bacterial count after removal of either Prevena or standard dressing. A micro-bacterial swap will be performed and sent to the microbiology lab for assessing bacterial count
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 14 days postopThe SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Outcome measures
| Measure |
Prevena
n=1 Participants
After surgery this group will receive the Prevena device (negative pressure wound therapy).
Prevena: Prevena Incision Management system
|
Standard Dressing
n=1 Participants
After surgery this group will receive standard of care dressings on their surgical wound.
Standard Dressing: This involves standard of care dressing including but not limited to gauze.
|
|---|---|---|
|
Physical Function as Assessed by Short Form Survey (SF) 36
|
100 units on a scale
Interval 100.0 to 100.0
|
85 units on a scale
Interval 85.0 to 85.0
|
SECONDARY outcome
Timeframe: Up to 30 days postopReadmission events for the patients.
Outcome measures
| Measure |
Prevena
n=1 Participants
After surgery this group will receive the Prevena device (negative pressure wound therapy).
Prevena: Prevena Incision Management system
|
Standard Dressing
n=1 Participants
After surgery this group will receive standard of care dressings on their surgical wound.
Standard Dressing: This involves standard of care dressing including but not limited to gauze.
|
|---|---|---|
|
Readmissions
|
0 readmission events
|
0 readmission events
|
SECONDARY outcome
Timeframe: Up to 14 days postopThe SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Outcome measures
| Measure |
Prevena
n=1 Participants
After surgery this group will receive the Prevena device (negative pressure wound therapy).
Prevena: Prevena Incision Management system
|
Standard Dressing
n=1 Participants
After surgery this group will receive standard of care dressings on their surgical wound.
Standard Dressing: This involves standard of care dressing including but not limited to gauze.
|
|---|---|---|
|
Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36
|
100 units on a scale
Interval 100.0 to 100.0
|
100 units on a scale
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to 14 days postopThe SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Outcome measures
| Measure |
Prevena
n=1 Participants
After surgery this group will receive the Prevena device (negative pressure wound therapy).
Prevena: Prevena Incision Management system
|
Standard Dressing
n=1 Participants
After surgery this group will receive standard of care dressings on their surgical wound.
Standard Dressing: This involves standard of care dressing including but not limited to gauze.
|
|---|---|---|
|
Social Functioning as Assessed by Short Form Survey (SF) 36
|
100 units on a scale
Interval 100.0 to 100.0
|
100 units on a scale
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to 14 days postopThe SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Energy and fatigue are aggregated in this section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Outcome measures
| Measure |
Prevena
n=1 Participants
After surgery this group will receive the Prevena device (negative pressure wound therapy).
Prevena: Prevena Incision Management system
|
Standard Dressing
n=1 Participants
After surgery this group will receive standard of care dressings on their surgical wound.
Standard Dressing: This involves standard of care dressing including but not limited to gauze.
|
|---|---|---|
|
Energy / Fatigue as Assessed by Short Form Survey (SF) 36
|
50 units on a scale
Interval 50.0 to 50.0
|
75 units on a scale
Interval 75.0 to 75.0
|
SECONDARY outcome
Timeframe: Up to 14 days postopThe SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Outcome measures
| Measure |
Prevena
n=1 Participants
After surgery this group will receive the Prevena device (negative pressure wound therapy).
Prevena: Prevena Incision Management system
|
Standard Dressing
n=1 Participants
After surgery this group will receive standard of care dressings on their surgical wound.
Standard Dressing: This involves standard of care dressing including but not limited to gauze.
|
|---|---|---|
|
Emotional Well Being as Assessed by Short Form Survey (SF) 36
|
60 units on a scale
Interval 60.0 to 60.0
|
60 units on a scale
Interval 60.0 to 60.0
|
SECONDARY outcome
Timeframe: Up to 14 days postopThe SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Outcome measures
| Measure |
Prevena
n=1 Participants
After surgery this group will receive the Prevena device (negative pressure wound therapy).
Prevena: Prevena Incision Management system
|
Standard Dressing
n=1 Participants
After surgery this group will receive standard of care dressings on their surgical wound.
Standard Dressing: This involves standard of care dressing including but not limited to gauze.
|
|---|---|---|
|
Pain as Assessed by Short Form Survey (SF) 36
|
100 units on a scale
Interval 100.0 to 100.0
|
100 units on a scale
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to 14 days postopThe SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Outcome measures
| Measure |
Prevena
n=1 Participants
After surgery this group will receive the Prevena device (negative pressure wound therapy).
Prevena: Prevena Incision Management system
|
Standard Dressing
n=1 Participants
After surgery this group will receive standard of care dressings on their surgical wound.
Standard Dressing: This involves standard of care dressing including but not limited to gauze.
|
|---|---|---|
|
General Health as Assessed by Short Form Survey (SF) 36
|
100 units on a scale
Interval 100.0 to 100.0
|
65 units on a scale
Interval 65.0 to 65.0
|
Adverse Events
Prevena
Standard Dressing
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