Negative Pressure Wound Therapy in Post-Operative Incision Management

NCT02682316 | Completed Phase 3 Results

• 1 other identifier: 15-309
• Study Type: interventional
• Target: 583
• Locations: 1 country
• Sites: 10

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.

Conditions

Negative-Pressure Wound Therapy

Keywords

undergoing laparotomy; 15-309

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

usual standard dry gauze used for wound management

ACTIVE COMPARATOR

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

Prevena Negative Pressure Wound Therapy System (NPWT)

EXPERIMENTAL

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

Interventions

dry gauze OTHER

usual standard dry gauze used for wound management

The Prevena Incision Management System DEVICE

Prevena Negative Pressure Wound Therapy System (NPWT)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women undergoing panniculectomy at the time of laparotomy
• Women with sensitivity to silver
• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• 3M: collaborator
• Miami Cancer Institute: collaborator

Study Sites (10)

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Consent and Follow-Up only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent and Follow-Up only)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Consent and Follow-Up only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Consent and Follow-Up only)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville (Consent and Follow-Up only)

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan Kettering Nassau (Consent and Follow-Up only)

Uniondale, New York, 11553, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Related Publications (1)

• 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.

  PMID: 33416292 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

Results Point of Contact

• Title: Dr. Mario Leitao, MD
• Organization: Memorial Sloan Kettering Cancer Center

leitaom@mskcc.org

212-639-3987

Study Officials

• Mario Leitao, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 15, 2016
• Study Start: February 1, 2016
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2024-01

Locations

US (10)