Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients

Not Applicable

Completed

• Conditions: Postoperative Complications; Gynecologic Neoplasms; Obesity
• Interventions: Procedure: Standard Wound Closure; Device: Prevena™ Incision Management System

• Registration Number: NCT02309944
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Study Timeline

• Study First Submitted: 2014-11-19
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-05
• Study Start: 2015-05
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Status Verified: 2020-07
• Results First Submitted: 2020-07-09
• Results First Submitted QC: 2020-07-24
• Last Update Submitted: 2020-07-24
• Results First Posted: 2020-07-27
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative Pressure Wound Therapy	Prevena™ Incision Management System	Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision.
Negative Pressure Wound Therapy	Standard Wound Closure	Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision.
Standard Wound Closure	Standard Wound Closure	Standard surgical closure of the fascia and skin.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection)	one month after surgery

Secondary Outcome Measures

Name	Time	Method
Time From Surgery to Starting Adjuvant Therapy Among Those With Confirmed Malignancies	up to 20 weeks

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States