Negative Pressure Wound Therapy in Post-Operative Incision Management
- Conditions
- Negative-Pressure Wound Therapy
- Registration Number
- NCT02682316
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 583
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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- 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
Memorial Sloan Kettering Bergen (Consent and Follow-Up only)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (Consent and Follow-Up only)
🇺🇸Commack, New York, United States
Memorial Sloan Kettering Westchester (Consent and Follow-Up only)
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Rockville (Consent and Follow-Up only)
🇺🇸Rockville Centre, New York, United States
Memorial Sloan Kettering Nassau (Consent and Follow-Up only)
🇺🇸Uniondale, New York, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Hartford Healthcare Cancer Institute @ Hartford Hospital🇺🇸Hartford, Connecticut, United States