Clinical trial NCT02682316: Negative Pressure Wound Therapy in Post-Operative Incision Management
Official title: A Phase III Randomized Controlled Trial of Negative Pressure Wound Therapy in Post-Operative Incision Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Negative-Pressure Wound Therapy
Keywords: undergoing laparotomy
15-309
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: 3M
name: Miami Cancer Institute
First posted: 2016-02-15
Enrollment: 583
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Post-op Wound Complications
timeFrame: 30 days +/- 5 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Healthcare Cancer Institute @ Hartford Hospital
state: Connecticut
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent and Follow-Up only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent and Follow-Up only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent and Follow-Up only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent and Follow-Up only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville (Consent and Follow-Up only)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent and Follow-Up only)
state: New York
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mario Leitao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leitao MM Jr, Zhou QC, Schiavone MB, Cowan RA, Smith ES, Iasonos A, Veith M, Rafizadeh M, Curran K, Ramesh B, Chang K, Chi DS, Sonoda Y, Brown AK, Cosin JA, Abu-Rustum NR, Martino MA, Mueller JJ, Long Roche K, Jewell EL, Broach V, Lambrou NC, Diaz JP, Zivanovic O. Prophylactic Negative Pressure Wound Therapy After Laparotomy for Gynecologic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2021 Feb 1;137(2):334-341. doi: 10.1097/AOG.0000000000004243.