Trial Outcomes & Findings for Use of Negative Pressure Wound Therapy in High Risk Surgical Closed Incisions (NCT NCT02137447)
NCT ID: NCT02137447
Last Updated: 2017-04-18
Results Overview
Incidence of SSIs within 1 month (4 weeks) from the index operation. SSI is defined by the Centers for Disease Control and Prevention's National Healthcare Surveillance Network
COMPLETED
PHASE4
10 participants
30 days
2017-04-18
Participant Flow
Participant milestones
| Measure |
Negative Pressure Wound Therapy
After the completion of the operation, incisional skin closure was performed using sutures or staples and the wound was then covered with the Negative Pressure Wound therapy Prevena Incision Management System (Kinetic Concepts Inc) as per the manufacturer's instructions of use. Continuous negative pressure was applied at 125 mm Hg.
For inpatients, wounds were assessed every 48 hours by inspection and palpation. The dressing was not routinely removed, but the surrounding skin was assessed for cellulitis. The NPWT dressing was removed between post-operative day 5 and 7.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Negative Pressure Wound Therapy in High Risk Surgical Closed Incisions
Baseline characteristics by cohort
| Measure |
Treatment Group
n=10 Participants
Negative Pressure treatment
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 daysIncidence of SSIs within 1 month (4 weeks) from the index operation. SSI is defined by the Centers for Disease Control and Prevention's National Healthcare Surveillance Network
Outcome measures
| Measure |
Treatment Group
n=10 Participants
Negative Pressure Wound Therapy (NPWT) to closed surgical incision
|
|---|---|
|
Number of Participants With Surgical Site Infections Within 1 Month (4 Weeks ) From Index Operation
|
1 Participants
|
SECONDARY outcome
Timeframe: 4 weeksSecondary (composite) outcomes: 1. other non infectious abdominal wound complications, 2. damage to the skin caused by the dressing 3. need to end the treatment prior the discharge OR prior to 5 -7 post- operative days. 4. need for re-application of the system for any reason
Outcome measures
| Measure |
Treatment Group
n=10 Participants
Negative Pressure Wound Therapy (NPWT) to closed surgical incision
|
|---|---|
|
Composite Secondary Outcomes of Non-infectious Abdominal Wound Complications, Damage to the Skin Caused by the Dressing, Need to End the Treatment Prior to Discharge or Prior to 5-7 Post-operative Days, and Need for Reapplication of the System.
|
0 Participants
|
Adverse Events
Treatment Group
Serious adverse events
| Measure |
Treatment Group
n=10 participants at risk
Negative Pressure Wound Therapy (NPWT) to closed surgical incision
|
|---|---|
|
General disorders
death
|
10.0%
1/10 • Number of events 1
|
Other adverse events
| Measure |
Treatment Group
n=10 participants at risk
Negative Pressure Wound Therapy (NPWT) to closed surgical incision
|
|---|---|
|
Renal and urinary disorders
urinary tract infection
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
intra-abdominal abscess requiring percutaneous drainage
|
10.0%
1/10 • Number of events 1
|
Additional Information
Dr. Daniel Dante Yeh, Assistant Professor of Surgery
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place