Obesity Clinical Trial
Official title:
Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients: A Randomized Controlled Trial
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.
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.
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