Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02682316 | Negative Pressure Wound Therapy in Post-Operative Incision Management | PHASE3 | COMPLETED | 583 | — | — | Feb 1, 2016 | Jan 25, 2024 | Mar 18, 2025 | 10 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| usual standard dry gauze used for wound management | ACTIVE_COMPARATOR | 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. |
| Prevena Negative Pressure Wound Therapy System (NPWT) | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| dry gauze | OTHER | - |
| The Prevena Incision Management System | DEVICE | - |
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...