Negative Pressure Wound Therapy in Post-Operative Incision Management

Negative-Pressure Wound Therapy Clinical Trial

Official title:

A Phase III Randomized Controlled Trial of Negative Pressure Wound Therapy in Post-Operative Incision Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02682316
• Other study ID #: 15-309
• Status: Completed
• Phase: Phase 3
• Start date: February 2016
• Est. completion date: January 25, 2024

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 577
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Negative-Pressure Wound Therapy
• Wounds and Injuries

Intervention

Other:
• dry gauze

Device:
• The Prevena Incision Management System

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only)	Basking Ridge	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	Hartford Healthcare Cancer Institute @ Hartford Hospital	Hartford	Connecticut
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 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

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	3M, Miami Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days +/- 5 days after surgery

External Links

•   Memorial Sloan Kettering Cancer Center