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

Johns Hopkins University

Status: Terminated

Conditions: Postoperative Complications; Wound Infection, Surgical; Obesity

Treatments: Device: Prevena; Device: Standard Dressing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02461433

IRB00030337

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

Prevena

Experimental group

Description:

After surgery this group will receive the Prevena device (negative pressure wound therapy).

Treatment:

Device: Prevena

Standard dressing

Active Comparator group

Description:

After surgery this group will receive standard of care dressings on their surgical wound.

Treatment:

Device: Standard Dressing