Negative Pressure Wound Therapy in Post-Operative Incision Management
NCT ID: NCT02682316
Last Updated: 2025-03-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
583 participants
INTERVENTIONAL
2016-02-29
2024-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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usual standard dry gauze used for wound management
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.
dry gauze
Prevena Negative Pressure Wound Therapy System (NPWT)
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.
The Prevena Incision Management System
Interventions
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dry gauze
The Prevena Incision Management System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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3M
INDUSTRY
Miami Cancer Institute
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Mario Leitao, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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15-309
Identifier Type: -
Identifier Source: org_study_id
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