Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients

University of Minnesota (UMN)

Status: Completed

Conditions: Postoperative Complications; Obesity; Gynecologic Neoplasms

Treatments: Procedure: Standard Wound Closure; Device: Prevena™ Incision Management System

Study type: Interventional

Funder types: Other

Identifiers

NCT02309944

2013NTLS073

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 2 patient groups

Standard Wound Closure

Active Comparator group

Description:

Standard surgical closure of the fascia and skin.

Treatment:

Procedure: Standard Wound Closure

Negative Pressure Wound Therapy

Experimental group

Description:

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

Treatment:

Device: Prevena™ Incision Management System

Procedure: Standard Wound Closure