NCT02309944

Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients

Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
DEVICE	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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2014-12-05
• Last updated: 2020-07-27
• Results posted: 2020-07-27

Locations

1 site across 1 country: United States