Trial Outcomes & Findings for Negative Pressure Wound Therapy in Post-Operative Incision Management (NCT NCT02682316)
NCT ID: NCT02682316
Last Updated: 2025-03-18
Results Overview
Incidence of inpatient post-operative wound complications will be documented through the use of an inpatient data collection sheet. Incidence of outpatient post-operative wound complication will be documented through the use of an outpatient data collection sheet that will be completed by a provider at the time of the routine post-operative follow-up visit, which will occur at 30 days +/- 5 days after the day of surgery as well as through ongoing documentation of events as elicited through the institution's standard reporting system to collect information on enrolled patients.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
583 participants
Primary outcome timeframe
30 days +/- 5 days after surgery
Results posted on
2025-03-18
Participant Flow
Participant milestones
| Measure |
Usual Standard Dry Gauze Used for Wound Management
Patients who are randomized to the standard dry gauze arm will have the standard dry gauze placed at time of wound closure. Their dressing will be removed on post-operative day 2 as per routine departmental practice.
dry gauze
|
Prevena Negative Pressure Wound Therapy System (NPWT)
Patients who are randomized to the Prevena Therapy System arm will have the Prevena Incision Management System device placed at time of wound closure. The device will be removed on day of discharge from the hospital or post-operative day 7, whichever comes first.
The Prevena Incision Management System
|
|---|---|---|
|
Overall Study
STARTED
|
294
|
289
|
|
Overall Study
COMPLETED
|
251
|
254
|
|
Overall Study
NOT COMPLETED
|
43
|
35
|
Reasons for withdrawal
| Measure |
Usual Standard Dry Gauze Used for Wound Management
Patients who are randomized to the standard dry gauze arm will have the standard dry gauze placed at time of wound closure. Their dressing will be removed on post-operative day 2 as per routine departmental practice.
dry gauze
|
Prevena Negative Pressure Wound Therapy System (NPWT)
Patients who are randomized to the Prevena Therapy System arm will have the Prevena Incision Management System device placed at time of wound closure. The device will be removed on day of discharge from the hospital or post-operative day 7, whichever comes first.
The Prevena Incision Management System
|
|---|---|---|
|
Overall Study
Benign Final Pathology
|
27
|
26
|
|
Overall Study
Reoperation before 30 days
|
7
|
6
|
|
Overall Study
Ineligible
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
7
|
3
|
Baseline Characteristics
Negative Pressure Wound Therapy in Post-Operative Incision Management
Baseline characteristics by cohort
| Measure |
Usual Standard Dry Gauze Used for Wound Management
n=294 Participants
Patients who are randomized to the standard dry gauze arm will have the standard dry gauze placed at time of wound closure. Their dressing will be removed on post-operative day 2 as per routine departmental practice.
dry gauze
|
Prevena Negative Pressure Wound Therapy System (NPWT)
n=289 Participants
Patients who are randomized to the Prevena Therapy System arm will have the Prevena Incision Management System device placed at time of wound closure. The device will be removed on day of discharge from the hospital or post-operative day 7, whichever comes first.
The Prevena Incision Management System
|
Total
n=583 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
61 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
294 Participants
n=5 Participants
|
289 Participants
n=7 Participants
|
583 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
278 Participants
n=5 Participants
|
267 Participants
n=7 Participants
|
545 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
245 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
478 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
294 Participants
n=5 Participants
|
289 Participants
n=7 Participants
|
583 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days +/- 5 days after surgeryIncidence of inpatient post-operative wound complications will be documented through the use of an inpatient data collection sheet. Incidence of outpatient post-operative wound complication will be documented through the use of an outpatient data collection sheet that will be completed by a provider at the time of the routine post-operative follow-up visit, which will occur at 30 days +/- 5 days after the day of surgery as well as through ongoing documentation of events as elicited through the institution's standard reporting system to collect information on enrolled patients.
Outcome measures
| Measure |
Usual Standard Dry Gauze Used for Wound Management
n=251 Participants
Patients who are randomized to the standard dry gauze arm will have the standard dry gauze placed at time of wound closure. Their dressing will be removed on post-operative day 2 as per routine departmental practice.
dry gauze
|
Prevena Negative Pressure Wound Therapy System (NPWT)
n=254 Participants
Patients who are randomized to the Prevena Therapy System arm will have the Prevena Incision Management System device placed at time of wound closure. The device will be removed on day of discharge from the hospital or post-operative day 7, whichever comes first.
The Prevena Incision Management System
|
|---|---|---|
|
Number of Post-op Wound Complications
Inpatient wound complication
|
2 Wound Complications
|
5 Wound Complications
|
|
Number of Post-op Wound Complications
Outpatient wound complication
|
42 Wound Complications
|
36 Wound Complications
|
Adverse Events
Usual Standard Dry Gauze Used for Wound Management
Serious events: 51 serious events
Other events: 11 other events
Deaths: 1 deaths
Prevena Negative Pressure Wound Therapy System (NPWT)
Serious events: 69 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Standard Dry Gauze Used for Wound Management
n=251 participants at risk
Patients who are randomized to the standard dry gauze arm will have the standard dry gauze placed at time of wound closure. Their dressing will be removed on post-operative day 2 as per routine departmental practice.
dry gauze
|
Prevena Negative Pressure Wound Therapy System (NPWT)
n=254 participants at risk
Patients who are randomized to the Prevena Therapy System arm will have the Prevena Incision Management System device placed at time of wound closure. The device will be removed on day of discharge from the hospital or post-operative day 7, whichever comes first.
The Prevena Incision Management System
|
|---|---|---|
|
Infections and infestations
Abdominal infection
|
1.2%
3/251 • 30 days +/- 5 days after surgery
|
0.79%
2/254 • 30 days +/- 5 days after surgery
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
3/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
5/251 • 30 days +/- 5 days after surgery
|
1.6%
4/254 • 30 days +/- 5 days after surgery
|
|
Gastrointestinal disorders
Ascites
|
1.2%
3/251 • 30 days +/- 5 days after surgery
|
1.2%
3/254 • 30 days +/- 5 days after surgery
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Cardiac disorders
Atrial fibrillation
|
0.80%
2/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Injury, poisoning and procedural complications
Biliary anastomotic leak
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Hepatobiliary disorders
Biliary fistula
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Hepatobiliary disorders
Cholecystitis
|
0.40%
1/251 • 30 days +/- 5 days after surgery
|
0.00%
0/254 • 30 days +/- 5 days after surgery
|
|
Gastrointestinal disorders
Colonic perforation
|
0.80%
2/251 • 30 days +/- 5 days after surgery
|
0.00%
0/254 • 30 days +/- 5 days after surgery
|
|
Gastrointestinal disorders
Diarrhea
|
0.40%
1/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Infections and infestations
Enterocolitis infectious
|
0.40%
1/251 • 30 days +/- 5 days after surgery
|
0.00%
0/254 • 30 days +/- 5 days after surgery
|
|
General disorders
Fever
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.79%
2/254 • 30 days +/- 5 days after surgery
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.80%
2/251 • 30 days +/- 5 days after surgery
|
0.00%
0/254 • 30 days +/- 5 days after surgery
|
|
Nervous system disorders
Headache
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Vascular disorders
Hematoma
|
0.40%
1/251 • 30 days +/- 5 days after surgery
|
0.79%
2/254 • 30 days +/- 5 days after surgery
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.40%
1/251 • 30 days +/- 5 days after surgery
|
0.00%
0/254 • 30 days +/- 5 days after surgery
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.40%
1/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Vascular disorders
Hypotension
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Gastrointestinal disorders
Ileus
|
4.0%
10/251 • 30 days +/- 5 days after surgery
|
5.1%
13/254 • 30 days +/- 5 days after surgery
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Injury, poisoning and procedural complications
Intraoperative splenic injury
|
0.40%
1/251 • 30 days +/- 5 days after surgery
|
0.00%
0/254 • 30 days +/- 5 days after surgery
|
|
Injury, poisoning and procedural complications
Large intestinal anastomotic leak
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.79%
2/254 • 30 days +/- 5 days after surgery
|
|
General disorders
Localized edema
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Infections and infestations
Lung infection
|
0.40%
1/251 • 30 days +/- 5 days after surgery
|
0.79%
2/254 • 30 days +/- 5 days after surgery
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders- Other, specify
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Gastrointestinal disorders
Nausea
|
0.40%
1/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
General disorders
Pain
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Injury, poisoning and procedural complications
Pancreatic anastomotic leak
|
0.40%
1/251 • 30 days +/- 5 days after surgery
|
0.00%
0/254 • 30 days +/- 5 days after surgery
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.79%
2/254 • 30 days +/- 5 days after surgery
|
|
Investigations
Platelet count decreased
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.40%
1/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Injury, poisoning and procedural complications
Rectal anastomotic leak
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.80%
2/251 • 30 days +/- 5 days after surgery
|
1.6%
4/254 • 30 days +/- 5 days after surgery
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.40%
1/251 • 30 days +/- 5 days after surgery
|
0.00%
0/254 • 30 days +/- 5 days after surgery
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Vascular disorders
Thromboembolic event
|
0.80%
2/251 • 30 days +/- 5 days after surgery
|
1.2%
3/254 • 30 days +/- 5 days after surgery
|
|
Injury, poisoning and procedural complications
Ureteric anastomotic leak
|
0.80%
2/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.40%
1/251 • 30 days +/- 5 days after surgery
|
0.00%
0/254 • 30 days +/- 5 days after surgery
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
|
Gastrointestinal disorders
Vomiting
|
0.80%
2/251 • 30 days +/- 5 days after surgery
|
0.00%
0/254 • 30 days +/- 5 days after surgery
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/251 • 30 days +/- 5 days after surgery
|
0.39%
1/254 • 30 days +/- 5 days after surgery
|
Other adverse events
| Measure |
Usual Standard Dry Gauze Used for Wound Management
n=251 participants at risk
Patients who are randomized to the standard dry gauze arm will have the standard dry gauze placed at time of wound closure. Their dressing will be removed on post-operative day 2 as per routine departmental practice.
dry gauze
|
Prevena Negative Pressure Wound Therapy System (NPWT)
n=254 participants at risk
Patients who are randomized to the Prevena Therapy System arm will have the Prevena Incision Management System device placed at time of wound closure. The device will be removed on day of discharge from the hospital or post-operative day 7, whichever comes first.
The Prevena Incision Management System
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin blistering
|
1.2%
3/251 • 30 days +/- 5 days after surgery
|
13.0%
33/254 • 30 days +/- 5 days after surgery
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
1.6%
4/251 • 30 days +/- 5 days after surgery
|
2.4%
6/254 • 30 days +/- 5 days after surgery
|
|
Injury, poisoning and procedural complications
Wound pain
|
0.80%
2/251 • 30 days +/- 5 days after surgery
|
2.4%
6/254 • 30 days +/- 5 days after surgery
|
|
Injury, poisoning and procedural complications
VAS pain level
|
0.80%
2/251 • 30 days +/- 5 days after surgery
|
2.4%
6/254 • 30 days +/- 5 days after surgery
|
Additional Information
Dr. Mario Leitao, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-3987
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place