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Negative Pressure Wound Therapy in Post-Operative Incision Management

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ClinicalTrials.gov Identifier: NCT02682316
Recruitment Status : Recruiting
First Posted : February 15, 2016
Last Update Posted : December 6, 2018
Sponsor:
Collaborators:
KCI USA, Inc.
Miami Cancer Institute
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Negative-Pressure Wound Therapy Other: dry gauze Device: The Prevena Incision Management System Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 686 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Controlled Trial of Negative Pressure Wound Therapy in Post-Operative Incision Management
Actual Study Start Date : February 2016
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Other: dry gauze
Experimental: 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.
Device: The Prevena Incision Management System



Primary Outcome Measures :
  1. number of post-op wound complications [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682316


Contacts
Contact: Mario Leitao, MD 212-639-3987
Contact: Oliver Zivanovic, MD,PhD 212-639-7033

Locations
United States, Connecticut
Hartford Healthcare Cancer Institute @ Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Jonathan Cosin, MD    860-826-1101      
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Mario Leitao, MD    212-639-3987      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Mario Leitao, MD    212-639-3987      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Mario Leitao, MD    212-639-3987      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Mario Leitao, MD    212-639-3987      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Mario Leitao, MD    212-639-3987      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Mario Leitao, MD    212-639-3987      
Memorial Sloan Kettering Rockville Recruiting
Rockville Centre, New York, United States, 11570
Contact: Mario Leitao, MD    212-639-3987      
United States, Pennsylvania
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Martin Martino, MD    610-402-3650      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
KCI USA, Inc.
Miami Cancer Institute
Investigators
Principal Investigator: Mario Leitao, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02682316     History of Changes
Other Study ID Numbers: 15-309
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
undergoing laparotomy
15-309

Additional relevant MeSH terms:
Wounds and Injuries