Trial Outcomes & Findings for Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients (NCT NCT02309944)
NCT ID: NCT02309944
Last Updated: 2020-07-27
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
one month after surgery
Results posted on
2020-07-27
Participant Flow
93 participants originally consented, one withdrew consent and 11 did not return updated HIPAA forms and therefore could not be included in the analysis
Participant milestones
| Measure |
Standard Wound Closure
Standard surgical closure of the fascia and skin.
|
Negative Pressure Wound Therapy
Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
43
|
|
Overall Study
COMPLETED
|
38
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients
Baseline characteristics by cohort
| Measure |
Standard Wound Closure
n=38 Participants
Standard surgical closure of the fascia and skin.
|
Negative Pressure Wound Therapy
n=43 Participants
Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
59.1 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
81 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
43 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one month after surgeryPopulation: Follow up data is not available for 2 participants
Outcome measures
| Measure |
Standard Wound Closure
n=37 Participants
Standard surgical closure of the fascia and skin.
|
Negative Pressure Wound Therapy
n=42 Participants
Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision.
|
|---|---|---|
|
Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection)
No
|
25 Participants
|
33 Participants
|
|
Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection)
Yes
|
12 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: up to 20 weeksPopulation: Only those participants who received adjuvant therapies were analyzed in both arms. Rest of the patients didn't have cancer that required subsequent therapies.
Outcome measures
| Measure |
Standard Wound Closure
n=19 Participants
Standard surgical closure of the fascia and skin.
|
Negative Pressure Wound Therapy
n=17 Participants
Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision.
|
|---|---|---|
|
Time From Surgery to Starting Adjuvant Therapy Among Those With Confirmed Malignancies
|
37 days
Interval 13.0 to 132.0
|
28 days
Interval 13.0 to 90.0
|
Adverse Events
Standard Wound Closure
Serious events: 7 serious events
Other events: 5 other events
Deaths: 0 deaths
Negative Pressure Wound Therapy
Serious events: 17 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Wound Closure
n=38 participants at risk
Standard surgical closure of the fascia and skin.
|
Negative Pressure Wound Therapy
n=43 participants at risk
Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision.
|
|---|---|---|
|
Gastrointestinal disorders
postop ileus
|
7.9%
3/38 • Upto 12 weeks after surgery
|
14.0%
6/43 • Upto 12 weeks after surgery
|
|
Blood and lymphatic system disorders
pulmonary embolism
|
0.00%
0/38 • Upto 12 weeks after surgery
|
4.7%
2/43 • Upto 12 weeks after surgery
|
|
Gastrointestinal disorders
Anastomotic leak
|
0.00%
0/38 • Upto 12 weeks after surgery
|
2.3%
1/43 • Upto 12 weeks after surgery
|
|
Skin and subcutaneous tissue disorders
Vaginal cuff dehiscence
|
0.00%
0/38 • Upto 12 weeks after surgery
|
2.3%
1/43 • Upto 12 weeks after surgery
|
|
Cardiac disorders
atrial fibrillation with rapid ventricular response
|
2.6%
1/38 • Upto 12 weeks after surgery
|
0.00%
0/43 • Upto 12 weeks after surgery
|
|
Cardiac disorders
Postop hypotension
|
2.6%
1/38 • Upto 12 weeks after surgery
|
4.7%
2/43 • Upto 12 weeks after surgery
|
|
Infections and infestations
Pelvic abscess
|
2.6%
1/38 • Upto 12 weeks after surgery
|
0.00%
0/43 • Upto 12 weeks after surgery
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
malignant ascites
|
0.00%
0/38 • Upto 12 weeks after surgery
|
2.3%
1/43 • Upto 12 weeks after surgery
|
|
Infections and infestations
Superficial wound infection, requiring readmission
|
0.00%
0/38 • Upto 12 weeks after surgery
|
4.7%
2/43 • Upto 12 weeks after surgery
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/38 • Upto 12 weeks after surgery
|
2.3%
1/43 • Upto 12 weeks after surgery
|
|
Gastrointestinal disorders
Bowel perforation
|
2.6%
1/38 • Upto 12 weeks after surgery
|
0.00%
0/43 • Upto 12 weeks after surgery
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.00%
0/38 • Upto 12 weeks after surgery
|
2.3%
1/43 • Upto 12 weeks after surgery
|
Other adverse events
| Measure |
Standard Wound Closure
n=38 participants at risk
Standard surgical closure of the fascia and skin.
|
Negative Pressure Wound Therapy
n=43 participants at risk
Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision.
|
|---|---|---|
|
Infections and infestations
Hospital-acquired pneumonia
|
2.6%
1/38 • Upto 12 weeks after surgery
|
0.00%
0/43 • Upto 12 weeks after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Postop hypoxia
|
2.6%
1/38 • Upto 12 weeks after surgery
|
0.00%
0/43 • Upto 12 weeks after surgery
|
|
Infections and infestations
Genital yeast infection
|
2.6%
1/38 • Upto 12 weeks after surgery
|
0.00%
0/43 • Upto 12 weeks after surgery
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/38 • Upto 12 weeks after surgery
|
2.3%
1/43 • Upto 12 weeks after surgery
|
|
Renal and urinary disorders
acute kidney injury
|
0.00%
0/38 • Upto 12 weeks after surgery
|
2.3%
1/43 • Upto 12 weeks after surgery
|
|
Infections and infestations
Superficial wound infection
|
5.3%
2/38 • Upto 12 weeks after surgery
|
2.3%
1/43 • Upto 12 weeks after surgery
|
Additional Information
Deanna GK Teoh
Masonic Cancer Center, University of Minnesota
Phone: 612-626-3111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place