NCT02461433

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

The SAVIOR Trial: Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Wound Infection, Surgical
• Obesity
• Postoperative Complications

Interventions

Type	Name	Description
DEVICE	Prevena	Prevena Incision Management system
DEVICE	Standard Dressing	This involves standard of care dressing including but not limited to gauze.

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2015-06-03
• Last updated: 2019-02-26
• Results posted: 2018-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study