Negative Pressure Wound Therapy in Post-Operative Incision Management



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:February 2016
End Date:February 2021
Contact:Mario Leitao, MD
Phone:212-639-3987

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A Phase III Randomized Controlled Trial of Negative Pressure Wound Therapy in Post-Operative Incision Management

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.


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
We found this trial at
10
sites
225 Summit Avenue
Montvale, New Jersey 07645
Phone: 212-639-3987
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Allentown, Pennsylvania 18105
Phone: 610-402-3650
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
Phone: 212-639-3987
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650 Commack Road
Commack, New York 11725
Phone: 212-639-3987
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Commack, NY
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1275 York Avenue
Harrison, New York 10604
Phone: 212-639-3987
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Harrison, NY
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Hartford, Connecticut 06102
Phone: 860-826-1101
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Hartford, CT
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480 Red Hill Road
Middletown, New Jersey 07748
Phone: 212-639-3987
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Middletown, NJ
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 212-639-3987
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Rockville Centre, New York 11570
Phone: 212-639-3987
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Rockville Centre, NY
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Uniondale, New York 11553
Phone: 212-639-3987
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Uniondale, NY
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