Obesity Clinical Trial
Official title:
The SAVIOR Trial: Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications
The purpose of this study is to determine whether application of an incisional wound Prevena trademark (TM) dressing (applies negative pressure to wounds) in the obese (BMI ≥30) surgical patient will reduce surgical site infections (SSI) when compared to the standard of care dressing.
In an attempt to decrease wound infection incidence and improve healing time of open surgical
wounds, vacuum assisted closure (VAC) was developed. This innovative technique provided
contained controlled wound irrigation without bacterial aerosolization. A newer customizable
subset of the Prevena incision Management System TM called Prevena Peel and Place TM has been
released a few months ago. The new model can be cut to specific wound sizes and has a
connector that can be attached to the already widely available VAC machines. The versatility
and the comparability to older models of Prevena Peel and Place TM have not been tested to
this date.
The investigators believe that a randomized clinical trial evaluating the use of the Prevena
Incision Management System TM for homecare and the use of Prevena Peel and Place TM for
inpatients in special populations is warranted. Obese patients (BMI≥30) undergoing open
surgery will have decreased surgical site infection rates, improved healing time, better
quality of life (QOL) and lower readmission rates with use of Prevena in the post-operative
management of surgical incisions.
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