Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications



Status:Terminated
Conditions:Obesity Weight Loss, Hospital, Hospital
Therapuetic Areas:Endocrinology, Other
Healthy:No
Age Range:18 - Any
Updated:2/28/2019
Start Date:June 2015
End Date:March 2017

Use our guide to learn which trials are right for you!

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.

Inclusion Criteria:

- Patient has been informed of the nature of the study, and has provided written
informed consent, approved by the appropriate Institutional Review Board (IRB) /
Medical Ethics Committee (MEC) of the respective clinical site.

- Patient meets the criteria for and is undergoing open surgery at Johns Hopkins Medical
Institutes.

- Patient with BMI≥ 30 at the time of surgery

- Patient agrees to return for all required clinical follow up for the study.

Exclusion Criteria:

- Known allergic reaction to acrylic adhesives or silver.

- Known history of intolerance to any component of Prevena Incision Management System
TM.

- Very fragile skin around incision site.

- Bleeding disorder or refuses blood transfusion.

- Malignancy or other condition limiting life expectancy to <5 years.

- Pregnancy
We found this trial at
1
site
Baltimore, Maryland 21287
Phone: 410-550-9509
?
mi
from
Baltimore, MD
Click here to add this to my saved trials