Trial Outcomes & Findings for Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical Site Infections (NCT NCT03021668)
NCT ID: NCT03021668
Last Updated: 2019-08-28
Results Overview
Surgical site infection will be diagnosed and classified based on the World Health Organization definition into superficial Infection (involving only skin and subcutaneous tissue of incision), deep incisional (involving deep tissues) or organ/space (involving organs and spaces other than the incision which was opened or manipulated during operation)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
124 participants
Primary outcome timeframe
Within 30 days of the operation
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
Prevena Peel & Place Dressing for Wound Closure
In the participants randomized to this arm the surgical site will be closed using Prevena Peel \& Place Dressing.
Prevena Peel \& Place Dressing: Prevena Peel \& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound
|
Standard Closure of the Wound
In the participants randomized to this arm the surgical site will be closed using the standard closure technique.
Standard Closure of the Surgical Incision: This would involve standard closure of the incision site
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
62
|
|
Overall Study
COMPLETED
|
62
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Prevena Peel & Place Dressing for Wound Closure
In the participants randomized to this arm the surgical site will be closed using Prevena Peel \& Place Dressing.
Prevena Peel \& Place Dressing: Prevena Peel \& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound
|
Standard Closure of the Wound
In the participants randomized to this arm the surgical site will be closed using the standard closure technique.
Standard Closure of the Surgical Incision: This would involve standard closure of the incision site
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical Site Infections
Baseline characteristics by cohort
| Measure |
Prevena Peel & Place Dressing for Wound Closure
n=62 Participants
In the participants randomized to this arm the surgical site will be closed using Prevena Peel \& Place Dressing.
Prevena Peel \& Place Dressing: Prevena Peel \& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound
|
Standard Closure of the Wound
n=61 Participants
In the participants randomized to this arm the surgical site will be closed using the standard closure technique.
Standard Closure of the Surgical Incision: This would involve standard closure of the incision site
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 9.3 • n=99 Participants
|
66.1 years
STANDARD_DEVIATION 9.0 • n=107 Participants
|
66.2 years
STANDARD_DEVIATION 9.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
62 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
|
Neoadjuvant therapy
|
44 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
American Society of Anesthesiologists (ASA) class
ASA I/II
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
American Society of Anesthesiologists (ASA) class
ASA III/IV
|
51 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Preincisional prophylactic antibiotic
|
62 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
|
Preoperative biliary stenting
|
51 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within 30 days of the operationSurgical site infection will be diagnosed and classified based on the World Health Organization definition into superficial Infection (involving only skin and subcutaneous tissue of incision), deep incisional (involving deep tissues) or organ/space (involving organs and spaces other than the incision which was opened or manipulated during operation)
Outcome measures
| Measure |
Prevena Peel & Place Dressing for Wound Closure
n=62 Participants
In the participants randomized to this arm the surgical site will be closed using Prevena Peel \& Place Dressing.
Prevena Peel \& Place Dressing: Prevena Peel \& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound
|
Standard Closure of the Wound
n=61 Participants
In the participants randomized to this arm the surgical site will be closed using the standard closure technique.
Standard Closure of the Surgical Incision: This would involve standard closure of the incision site
|
|---|---|---|
|
Rate of Surgical Site Infection
|
6 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Within 10 days of surgeryLength of stay of patient at the hospital from date of surgery
Outcome measures
| Measure |
Prevena Peel & Place Dressing for Wound Closure
n=62 Participants
In the participants randomized to this arm the surgical site will be closed using Prevena Peel \& Place Dressing.
Prevena Peel \& Place Dressing: Prevena Peel \& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound
|
Standard Closure of the Wound
n=61 Participants
In the participants randomized to this arm the surgical site will be closed using the standard closure technique.
Standard Closure of the Surgical Incision: This would involve standard closure of the incision site
|
|---|---|---|
|
Prolonged Length of Stay, Measured in Days
|
7 days
Interval 7.0 to 10.0
|
8 days
Interval 7.0 to 10.0
|
SECONDARY outcome
Timeframe: Within 30 days of operationAny readmission for surgical site infections (SSIs) related to the surgery within the first 30 days after surgery
Outcome measures
| Measure |
Prevena Peel & Place Dressing for Wound Closure
n=62 Participants
In the participants randomized to this arm the surgical site will be closed using Prevena Peel \& Place Dressing.
Prevena Peel \& Place Dressing: Prevena Peel \& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound
|
Standard Closure of the Wound
n=61 Participants
In the participants randomized to this arm the surgical site will be closed using the standard closure technique.
Standard Closure of the Surgical Incision: This would involve standard closure of the incision site
|
|---|---|---|
|
Rate of Readmission for Surgical Site Infections (SSIs)
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Within 30 days of surgeryNeed for 30-day readmission
Outcome measures
| Measure |
Prevena Peel & Place Dressing for Wound Closure
n=62 Participants
In the participants randomized to this arm the surgical site will be closed using Prevena Peel \& Place Dressing.
Prevena Peel \& Place Dressing: Prevena Peel \& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound
|
Standard Closure of the Wound
n=61 Participants
In the participants randomized to this arm the surgical site will be closed using the standard closure technique.
Standard Closure of the Surgical Incision: This would involve standard closure of the incision site
|
|---|---|---|
|
30-d Readmission
|
5 Participants
|
12 Participants
|
Adverse Events
Prevena Peel & Place Dressing for Wound Closure
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Standard Closure of the Wound
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prevena Peel & Place Dressing for Wound Closure
n=62 participants at risk
In the participants randomized to this arm the surgical site will be closed using Prevena Peel \& Place Dressing.
Prevena Peel \& Place Dressing: Prevena Peel \& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound
|
Standard Closure of the Wound
n=61 participants at risk
In the participants randomized to this arm the surgical site will be closed using the standard closure technique.
Standard Closure of the Surgical Incision: This would involve standard closure of the incision site
|
|---|---|---|
|
Hepatobiliary disorders
Postoperative pancreatic fistula
|
4.8%
3/62 • Number of events 3 • Within 90 days of surgery
|
11.5%
7/61 • Number of events 7 • Within 90 days of surgery
|
|
Gastrointestinal disorders
Delayed gastric emptying
|
9.7%
6/62 • Number of events 6 • Within 90 days of surgery
|
9.8%
6/61 • Number of events 6 • Within 90 days of surgery
|
|
Respiratory, thoracic and mediastinal disorders
Postoperative respiratory complications
|
4.8%
3/62 • Number of events 3 • Within 90 days of surgery
|
13.1%
8/61 • Number of events 8 • Within 90 days of surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place