Trial Outcomes & Findings for Prevena™ Incisional Negative Pressure Wound Therapy in Re-operative Colorectal Surgery (NCT NCT02509260)
NCT ID: NCT02509260
Last Updated: 2022-11-14
Results Overview
Diagnosis will be based on criteria developed by the Centers for Disease Control (CDC)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
298 participants
Primary outcome timeframe
within 30 days after the operation
Results posted on
2022-11-14
Participant Flow
Participant milestones
| Measure |
Prevena™ Incisional NPWT
Prevena wound management system: Post op application of the Prevena™ wound management system will be applied.
Prevena wound management system: Patients will have the Prevena wound management system applied post-operatively.
|
Standard Wound Dressings
Standard Wound Dressings: Control patients with standard wound dressings will have gauze and tape dressings applied.
Standard wound dressings: Control patients with standard wound dressings will have gauze and tape dressings applied
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
149
|
|
Overall Study
COMPLETED
|
149
|
149
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prevena™ Incisional NPWT
n=149 Participants
Prevena wound management system: Post op application of the Prevena™ wound management system will be applied.
Prevena wound management system: Patients will have the Prevena wound management system applied post-operatively.
|
Standard Wound Dressings
n=149 Participants
Standard Wound Dressings: Control patients with standard wound dressings will have gauze and tape dressings applied.
Standard wound dressings: Control patients with standard wound dressings will have gauze and tape dressings applied
|
Total
n=298 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 16.4 • n=149 Participants
|
52.2 years
STANDARD_DEVIATION 15.1 • n=149 Participants
|
51 years
STANDARD_DEVIATION 15.8 • n=298 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=149 Participants
|
73 Participants
n=149 Participants
|
147 Participants
n=298 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=149 Participants
|
76 Participants
n=149 Participants
|
151 Participants
n=298 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: within 30 days after the operationDiagnosis will be based on criteria developed by the Centers for Disease Control (CDC)
Outcome measures
| Measure |
Prevena™ Incisional NPWT
n=118 Participants
Prevena wound management system: Post op application of the Prevena™ wound management system will be applied.
Prevena wound management system: Patients will have the Prevena wound management system applied post-operatively.
|
Standard Wound Dressings
n=149 Participants
Standard Wound Dressings: Control patients with standard wound dressings will have gauze and tape dressings applied.
Standard wound dressings: Control patients with standard wound dressings will have gauze and tape dressings applied
|
|---|---|---|
|
Occurrence of Superficial Surgical Site Infection
Superficial Surgical Site Infection
|
11 Participants
|
21 Participants
|
|
Occurrence of Superficial Surgical Site Infection
No Superficial Surgical Site Infection
|
107 Participants
|
128 Participants
|
SECONDARY outcome
Timeframe: 30 days after operationnumber of days in hospital after surgery day
Outcome measures
| Measure |
Prevena™ Incisional NPWT
n=118 Participants
Prevena wound management system: Post op application of the Prevena™ wound management system will be applied.
Prevena wound management system: Patients will have the Prevena wound management system applied post-operatively.
|
Standard Wound Dressings
n=149 Participants
Standard Wound Dressings: Control patients with standard wound dressings will have gauze and tape dressings applied.
Standard wound dressings: Control patients with standard wound dressings will have gauze and tape dressings applied
|
|---|---|---|
|
Length of Hospital Stay,
|
7 Days
Interval 5.0 to 9.0
|
6 Days
Interval 5.0 to 10.0
|
SECONDARY outcome
Timeframe: 30 days after operationPopulation: Study team ultimately decided not to collect this data
ratio of costs between intervention and control group
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days after operationdifference in SSI between groups
Outcome measures
| Measure |
Prevena™ Incisional NPWT
n=149 Participants
Prevena wound management system: Post op application of the Prevena™ wound management system will be applied.
Prevena wound management system: Patients will have the Prevena wound management system applied post-operatively.
|
Standard Wound Dressings
n=149 Participants
Standard Wound Dressings: Control patients with standard wound dressings will have gauze and tape dressings applied.
Standard wound dressings: Control patients with standard wound dressings will have gauze and tape dressings applied
|
|---|---|---|
|
Clinical Efficacy of the Device in Relation to the Degree of Contamination
Dirty
|
39 Participants
|
45 Participants
|
|
Clinical Efficacy of the Device in Relation to the Degree of Contamination
Clean-Contaminated
|
15 Participants
|
12 Participants
|
|
Clinical Efficacy of the Device in Relation to the Degree of Contamination
Contaminated
|
94 Participants
|
90 Participants
|
|
Clinical Efficacy of the Device in Relation to the Degree of Contamination
No contamination
|
1 Participants
|
2 Participants
|
Adverse Events
Prevena™ Incisional NPWT
Serious events: 11 serious events
Other events: 92 other events
Deaths: 0 deaths
Standard Wound Dressings
Serious events: 19 serious events
Other events: 84 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Prevena™ Incisional NPWT
n=149 participants at risk
Prevena wound management system: Post op application of the Prevena™ wound management system will be applied.
Prevena wound management system: Patients will have the Prevena wound management system applied post-operatively.
|
Standard Wound Dressings
n=149 participants at risk
Standard Wound Dressings: Control patients with standard wound dressings will have gauze and tape dressings applied.
Standard wound dressings: Control patients with standard wound dressings will have gauze and tape dressings applied
|
|---|---|---|
|
Infections and infestations
Abcess
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Renal and urinary disorders
Bladder Injury
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Insufficiency
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Infections and infestations
Sepsis
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Vascular disorders
Portal Vein Thrombosis
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Blood and lymphatic system disorders
Anemia
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
|
Psychiatric disorders
Altered mental status
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
|
Surgical and medical procedures
Reoperation
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Gastrointestinal disorders
Ileus
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Cardiac disorders
Hypotension
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
|
General disorders
Abdominal Pain
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
|
Investigations
Hyperglycemia
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Gastrointestinal disorders
Bowel Perforation
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Gastrointestinal disorders
Rectal Bleeding
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
|
Cardiac disorders
Elevated Heart Rate
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Vascular disorders
Pulmonary Embolism
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Injury, poisoning and procedural complications
Internal Bleeding
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Gastrointestinal disorders
Ileostomy Ischemia
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
Other adverse events
| Measure |
Prevena™ Incisional NPWT
n=149 participants at risk
Prevena wound management system: Post op application of the Prevena™ wound management system will be applied.
Prevena wound management system: Patients will have the Prevena wound management system applied post-operatively.
|
Standard Wound Dressings
n=149 participants at risk
Standard Wound Dressings: Control patients with standard wound dressings will have gauze and tape dressings applied.
Standard wound dressings: Control patients with standard wound dressings will have gauze and tape dressings applied
|
|---|---|---|
|
Gastrointestinal disorders
Ileus
|
14.8%
22/149 • Number of events 22 • 30 days post surgery (+/- 7 days)
|
15.4%
23/149 • Number of events 23 • 30 days post surgery (+/- 7 days)
|
|
Infections and infestations
Pneumonia
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Blood and lymphatic system disorders
Anemia
|
5.4%
8/149 • Number of events 8 • 30 days post surgery (+/- 7 days)
|
8.1%
12/149 • Number of events 12 • 30 days post surgery (+/- 7 days)
|
|
Renal and urinary disorders
Ureteric Injury
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Renal and urinary disorders
Urinary Retention
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
6.0%
9/149 • Number of events 9 • 30 days post surgery (+/- 7 days)
|
|
General disorders
Dehydration
|
2.7%
4/149 • Number of events 4 • 30 days post surgery (+/- 7 days)
|
2.0%
3/149 • Number of events 3 • 30 days post surgery (+/- 7 days)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
General disorders
Abdominal Distension
|
2.0%
3/149 • Number of events 3 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Gastrointestinal disorders
Nausea
|
2.0%
3/149 • Number of events 3 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Infections and infestations
Abdominal Abscess
|
2.7%
4/149 • Number of events 4 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Infections and infestations
Urinary Tract Infection
|
3.4%
5/149 • Number of events 5 • 30 days post surgery (+/- 7 days)
|
3.4%
5/149 • Number of events 5 • 30 days post surgery (+/- 7 days)
|
|
Gastrointestinal disorders
Obstruction
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Infections and infestations
Wound Infection
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Insufficiency
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Infections and infestations
Central Line bloodstream infection
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Infections and infestations
Sepsis
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
General disorders
Fever
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Gastrointestinal disorders
High Ileostomy Output
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
|
General disorders
Abdominal Pain
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
3/149 • Number of events 3 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Gastrointestinal disorders
Decreased Stoma output
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
General disorders
Increased Drainage
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
|
General disorders
Seroma/ Fluid Collection
|
2.0%
3/149 • Number of events 3 • 30 days post surgery (+/- 7 days)
|
2.0%
3/149 • Number of events 3 • 30 days post surgery (+/- 7 days)
|
|
Cardiac disorders
Hypotension
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
|
Gastrointestinal disorders
Malnutrition
|
0.67%
1/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Surgical and medical procedures
Reoperation due to stoma kinking
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Blood and lymphatic system disorders
Elevated White Blood Cells
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Gastrointestinal disorders
Short Gut Syndrome
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Gastrointestinal disorders
Rectal Bleeding
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
2.0%
3/149 • Number of events 3 • 30 days post surgery (+/- 7 days)
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
|
Infections and infestations
C. Diff
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
General disorders
Mucosal Separation
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Blood and lymphatic system disorders
Blood Clots from Stoma
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
General disorders
Lightheadness
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Infections and infestations
Enteritis
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Cardiac disorders
Atrial Fibrillation
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
|
General disorders
Gas
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Surgical and medical procedures
Placement/ replacement of Lines/ Tubes
|
1.3%
2/149 • Number of events 2 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
General disorders
Leg Swelling
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Investigations
Increased Creatinine
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Infections and infestations
Pancreatitis
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Psychiatric disorders
Confusion
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
|
Vascular disorders
Pulmonary Embolism
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
General disorders
Wound Leak
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
|
General disorders
Back Pain
|
0.67%
1/149 • Number of events 1 • 30 days post surgery (+/- 7 days)
|
0.00%
0/149 • 30 days post surgery (+/- 7 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place