Negative Pressure Wound Therapy in Post-Operative Incision Management

Memorial Sloan Kettering Cancer Center583 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

583

Conditions

Negative-Pressure Wound Therapy

Interventions

dry gauzeOTHER

The Prevena Incision Management SystemDEVICE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, United States

Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent and Follow-Up only)

Middletown, New Jersey, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.