Negative Pressure Wound Therapy in Post-Operative Incision Management

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed
Phase 3

Conditions

Negative-Pressure Wound Therapy

Treatments

Other: dry gauze
Device: The Prevena Incision Management System

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02682316
15-309

Details and patient eligibility

About

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.

Enrollment

577 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

577 participants in 2 patient groups

usual standard dry gauze used for wound management
Active Comparator group
Description:
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.
Treatment:
Other: dry gauze
Prevena Negative Pressure Wound Therapy System (NPWT)
Experimental group
Description:
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.
Treatment:
Device: The Prevena Incision Management System

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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