Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients

NCT ID: NCT02309944

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2020-06-30

Brief Summary

The purpose of the study is to test whether the use of a new wound closure technique can decrease the rates of wound complications in obese cancer patients.

Detailed Description

Most gynecologic and many intra-abdominal malignancies are treated with an initial surgical procedure. There has been a dramatic increase in obesity rates in the US with more than one third of US adults being obese (Body Mass Index (BMI) of > 30kg/m2). There is a direct link between obesity and wound complications following surgery with an increasing BMI leading to increasing rates of complications. Negative pressure wound therapy (NPWT) is a system that utilizes sub-atmospheric pressure to improve wound healing by increasing the formation of granulation tissue. NPWT has been shown to improve outcomes in both the orthopedic and cardiothoracic surgery populations. To date, there is no prospective study evaluating the application of prophylactic NPWT in laparotomy patients.

This study will be a randomized clinical trial. Patients will be enrolled at the time of consent for laparotomy for suspected gynecologic malignancy. Participants will be randomized to one of two groups: 1) Standard closure group (control arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method; or 2) NPWT group (study arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method + placement of a negative pressure wound therapy device over the closed incision for 2-3 days, with removal of the device prior to hospital discharge. The rate of wound complications for two groups will be compared.

Conditions

Postoperative Complications; Obesity; Gynecologic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard Wound Closure

Standard surgical closure of the fascia and skin.

Group Type: ACTIVE_COMPARATOR

Standard Wound Closure

Intervention Type: PROCEDURE

The standard surgical closure consists of closure of the fascia with a looped polydioxanone (PDS) suture in a running fashion either in with the use of a mass closure technique or a Smead Jones closure at the discretion of the operating surgeon, closure of the subcutaneous space if \>2 cm deep, followed by staple or suture closure of the skin.

Negative Pressure Wound Therapy

Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision.

Group Type: EXPERIMENTAL

Standard Wound Closure

Intervention Type: PROCEDURE

The standard surgical closure consists of closure of the fascia with a looped polydioxanone (PDS) suture in a running fashion either in with the use of a mass closure technique or a Smead Jones closure at the discretion of the operating surgeon, closure of the subcutaneous space if \>2 cm deep, followed by staple or suture closure of the skin.

Prevena™ Incision Management System

Intervention Type: DEVICE

At the close of surgery, the Prevena™ Incision Management System will be placed over the closed incision. It will be removed on post-operative day 2 or 3 as clinically indicated and prior to the patient's discharge from the hospital.

Interventions

Standard Wound Closure

The standard surgical closure consists of closure of the fascia with a looped polydioxanone (PDS) suture in a running fashion either in with the use of a mass closure technique or a Smead Jones closure at the discretion of the operating surgeon, closure of the subcutaneous space if \>2 cm deep, followed by staple or suture closure of the skin.

Intervention Type: PROCEDURE

Prevena™ Incision Management System

At the close of surgery, the Prevena™ Incision Management System will be placed over the closed incision. It will be removed on post-operative day 2 or 3 as clinically indicated and prior to the patient's discharge from the hospital.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Known or suspected gynecologic or other abdominal malignancy (such as colorectal, liver, pancreatic, kidney and stomach) for which laparotomy is planned
• Obese - defined as a Body Mass Index (BMI) ≥ 35 kg/m2 as calculated in the Epic computer record

Exclusion Criteria

• Known true tape allergy
• Sensitivity to silver
• History of intolerance to Negative Pressure Wound Therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deanna G. Teoh, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2013NTLS073

Identifier Type: -

Identifier Source: org_study_id