Trial Outcomes & Findings for Closed Incision Negative Pressure Therapy vs Standard of Care (NCT NCT03061903)
NCT ID: NCT03061903
Last Updated: 2023-04-11
Results Overview
Occurrence of wound complications (wound drainage, breakdown, necrosis, dehiscence, superficial or deep infection) requiring additional intervention. Intervention will be defined as any attempt of the surgeon to improve wound healing (in-office debridement, topical ointment, aspiration, antibiotic therapy, or return to the OR for the wound).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
Up to 90 days
Results posted on
2023-04-11
Participant Flow
Participant milestones
| Measure |
Prevena
Subjects will receive PREVENA after surgery.
Prevena: Closed Incision Negative Pressure Therapy (bandage over the incision sealed with negative pressure of a vacuum) to be placed on after surgery for 7 days.
Prevena™, by KCI, is currently being used selectively in high-risk patients and a FDA-approved device.
|
Aquacel
Subjects will receive AQUACEL Ag after surgery.
Aquacel: Water resistant, silver-impregnated, antimicrobial hydrofiber dressing that is placed on after surgery for 7 days.
AQUACEL® Ag, by Convatec, is currently the standard of care for postoperative wound dressing and a FDA-approved device.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prevena
n=60 Participants
Subjects will receive PREVENA after surgery.
Prevena: Closed Incision Negative Pressure Therapy (bandage over the incision sealed with negative pressure of a vacuum) to be placed on after surgery for 7 days.
Prevena™, by KCI, is currently being used selectively in high-risk patients and a FDA-approved device.
|
Aquacel
n=60 Participants
Subjects will receive AQUACEL Ag after surgery.
Aquacel: Water resistant, silver-impregnated, antimicrobial hydrofiber dressing that is placed on after surgery for 7 days.
AQUACEL® Ag, by Convatec, is currently the standard of care for postoperative wound dressing and a FDA-approved device.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=120 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=60 Participants
|
27 Participants
n=60 Participants
|
60 Participants
n=120 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=60 Participants
|
33 Participants
n=60 Participants
|
60 Participants
n=120 Participants
|
|
Age, Continuous
|
63.6 years
n=60 Participants
|
64.4 years
n=60 Participants
|
64 years
n=120 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=60 Participants
|
37 Participants
n=60 Participants
|
76 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=60 Participants
|
23 Participants
n=60 Participants
|
44 Participants
n=120 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
3 participants
n=60 Participants
|
2 participants
n=60 Participants
|
5 participants
n=120 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=60 Participants
|
58 participants
n=60 Participants
|
115 participants
n=120 Participants
|
PRIMARY outcome
Timeframe: Up to 90 daysPopulation: 2 out of the 122 enrolled participants did not complete the study and therefore were not included in the data analysis.
Occurrence of wound complications (wound drainage, breakdown, necrosis, dehiscence, superficial or deep infection) requiring additional intervention. Intervention will be defined as any attempt of the surgeon to improve wound healing (in-office debridement, topical ointment, aspiration, antibiotic therapy, or return to the OR for the wound).
Outcome measures
| Measure |
Prevena
n=60 Participants
Subjects will receive PREVENA after surgery.
Prevena: Closed Incision Negative Pressure Therapy (bandage over the incision sealed with negative pressure of a vacuum) to be placed on after surgery for 7 days.
Prevena™, by KCI, is currently being used selectively in high-risk patients and a FDA-approved device.
|
Aquacel
n=60 Participants
Subjects will receive AQUACEL Ag after surgery.
Aquacel: Water resistant, silver-impregnated, antimicrobial hydrofiber dressing that is placed on after surgery for 7 days.
AQUACEL® Ag, by Convatec, is currently the standard of care for postoperative wound dressing and a FDA-approved device.
|
|---|---|---|
|
Prevalence of Wound Complications
|
5 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: 2 out of the 122 enrolled participants did not complete the study and therefore were not included in the data analysis.
Number of patients who met CDC criteria for superficial surgical site infection (SSI).
Outcome measures
| Measure |
Prevena
n=60 Participants
Subjects will receive PREVENA after surgery.
Prevena: Closed Incision Negative Pressure Therapy (bandage over the incision sealed with negative pressure of a vacuum) to be placed on after surgery for 7 days.
Prevena™, by KCI, is currently being used selectively in high-risk patients and a FDA-approved device.
|
Aquacel
n=60 Participants
Subjects will receive AQUACEL Ag after surgery.
Aquacel: Water resistant, silver-impregnated, antimicrobial hydrofiber dressing that is placed on after surgery for 7 days.
AQUACEL® Ag, by Convatec, is currently the standard of care for postoperative wound dressing and a FDA-approved device.
|
|---|---|---|
|
Number of Patients With Superficial Surgical Site Infections
|
2 Participants
|
9 Participants
|
Adverse Events
Prevena
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Aquacel
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prevena
n=60 participants at risk
Subjects will receive PREVENA after surgery.
Prevena: Closed Incision Negative Pressure Therapy (bandage over the incision sealed with negative pressure of a vacuum) to be placed on after surgery for 7 days.
Prevena™, by KCI, is currently being used selectively in high-risk patients and a FDA-approved device.
|
Aquacel
n=60 participants at risk
Subjects will receive AQUACEL Ag after surgery.
Aquacel: Water resistant, silver-impregnated, antimicrobial hydrofiber dressing that is placed on after surgery for 7 days.
AQUACEL® Ag, by Convatec, is currently the standard of care for postoperative wound dressing and a FDA-approved device.
|
|---|---|---|
|
Surgical and medical procedures
Acute periprosthetic joint infection
|
1.7%
1/60 • Number of events 1 • 90 days
|
0.00%
0/60 • 90 days
|
Other adverse events
| Measure |
Prevena
n=60 participants at risk
Subjects will receive PREVENA after surgery.
Prevena: Closed Incision Negative Pressure Therapy (bandage over the incision sealed with negative pressure of a vacuum) to be placed on after surgery for 7 days.
Prevena™, by KCI, is currently being used selectively in high-risk patients and a FDA-approved device.
|
Aquacel
n=60 participants at risk
Subjects will receive AQUACEL Ag after surgery.
Aquacel: Water resistant, silver-impregnated, antimicrobial hydrofiber dressing that is placed on after surgery for 7 days.
AQUACEL® Ag, by Convatec, is currently the standard of care for postoperative wound dressing and a FDA-approved device.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Surgical site complications
|
8.3%
5/60 • Number of events 5 • 90 days
|
18.3%
11/60 • Number of events 11 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place