Negative-Pressure Wound Therapy
Conditions
Keywords
undergoing laparotomy, 15-309
Brief summary
The purpose of this study is to compare any good and bad effects of using the Prevena Incision Management System to using the usual standard dry gauze approach. The Prevena Incision Management System is a type of Negative Pressure Wound Therapy (NPWT). NPWT is a portable vacuum device made of a sponge-like foam that is applied over your incision to help draw fluid and debris out after surgery.
Interventions
OTHERdry gauze
DEVICEThe Prevena Incision Management System
Sponsors
3M
Miami Cancer Institute
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Criteria for Eligibility Prior to Surgery: * Women of any BMI undergoing a laparotomy procedure for a presumed gynecologic malignancy, or morbidly obese (BMI ≥ 40) women undergoing a laparotomy for any indication * or women who are morbidly obese (BMI\>40) undergoing laparotomy for any indication * Age ≥ 18 Criteria for Eligibility During Surgery: * Women of any BMI undergoing a laparotomy procedure for a presumed gynecologic malignancy, or morbidly obese (BMI ≥ 40) women undergoing a laparotomy for any indication * or women who are morbidly obese (BMI\>40) undergoing laparotomy for any indication * Age ≥ 18
Exclusion criteria
Exclusion prior to Surgery: * Women undergoing panniculectomy at the time of laparotomy * Women with sensitivity to silver Exclusion during Surgery: * Women with laparotomy incisions left open due to case classification as contaminated or dirty * Women with laparotomy incisions unable to be closed primarily due to tissue or fascial damage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Post-op Wound Complications | 30 days +/- 5 days after surgery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 294 |
| 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 | 289 |
| Total | 583 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Benign Final Pathology | 27 | 26 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Ineligible | 1 | 0 |
| Overall Study | Lost to Follow-up | 7 | 3 |
| Overall Study | Reoperation before 30 days | 7 | 6 |
Baseline characteristics
| Characteristic | Usual Standard Dry Gauze Used for Wound Management | Total | Prevena Negative Pressure Wound Therapy System (NPWT) |
|---|---|---|---|
| Age, Continuous | 60 years | 60 years | 61 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 38 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 278 Participants | 545 Participants | 267 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 39 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 37 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 29 Participants | 10 Participants |
| Race (NIH/OMB) White | 245 Participants | 478 Participants | 233 Participants |
| Region of Enrollment United States | 294 Participants | 583 Participants | 289 Participants |
| Sex: Female, Male Female | 294 Participants | 583 Participants | 289 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 251 | 0 / 254 |
| other Total, other adverse events | 11 / 251 | 44 / 254 |
| serious Total, serious adverse events | 51 / 251 | 69 / 254 |
Outcome results
Primary
Number of Post-op Wound Complications
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.
Time frame: 30 days +/- 5 days after surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Standard Dry Gauze Used for Wound Management | Number of Post-op Wound Complications | Inpatient wound complication | 2 Wound Complications |
| Usual Standard Dry Gauze Used for Wound Management | Number of Post-op Wound Complications | Outpatient wound complication | 42 Wound Complications |
| Prevena Negative Pressure Wound Therapy System (NPWT) | Number of Post-op Wound Complications | Inpatient wound complication | 5 Wound Complications |
| Prevena Negative Pressure Wound Therapy System (NPWT) | Number of Post-op Wound Complications | Outpatient wound complication | 36 Wound Complications |