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Negative Pressure Wound Therapy in Post-Operative Incision Management

Primary Purpose

Negative-Pressure Wound Therapy

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
dry gauze
The Prevena Incision Management System
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Negative-Pressure Wound Therapy focused on measuring undergoing laparotomy, 15-309

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Hartford Healthcare Cancer Institute @ Hartford Hospital
  • Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only)
  • Memorial Sloan Kettering Monmouth (Consent and Follow-Up only)
  • Memorial Sloan Kettering Bergen (Consent and Follow-Up only)
  • Memorial Sloan Kettering Commack (Consent and Follow-Up only)
  • Memorial Sloan Kettering Westchester (Consent and Follow-Up only)
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Rockville (Consent and Follow-Up only)
  • Memorial Sloan Kettering Nassau (Consent and Follow-Up only)
  • Lehigh Valley Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

usual standard dry gauze used for wound management

Prevena Negative Pressure Wound Therapy System (NPWT)

Arm 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.

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.

Outcomes

Primary Outcome Measures

number of post-op wound complications
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.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2016
Last Updated
March 1, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
3M, Miami Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02682316
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2016 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
3M, Miami Cancer Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Negative-Pressure Wound Therapy
Keywords
undergoing laparotomy, 15-309

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
577 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
usual standard dry gauze used for wound management
Arm Type
Active Comparator
Arm 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.
Arm Title
Prevena Negative Pressure Wound Therapy System (NPWT)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
dry gauze
Intervention Type
Device
Intervention Name(s)
The Prevena Incision Management System
Primary Outcome Measure Information:
Title
number of post-op wound complications
Description
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.
Time Frame
30 days +/- 5 days after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Leitao, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Healthcare Cancer Institute @ Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth (Consent and Follow-Up only)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen (Consent and Follow-Up only)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack (Consent and Follow-Up only)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester (Consent and Follow-Up only)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Rockville (Consent and Follow-Up only)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Memorial Sloan Kettering Nassau (Consent and Follow-Up only)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33416292
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.
Results Reference
derived
Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

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Negative Pressure Wound Therapy in Post-Operative Incision Management

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