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

NCT ID: NCT02461433

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prevena

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

Group Type: EXPERIMENTAL

Prevena

Intervention Type: DEVICE

Prevena Incision Management system

Standard dressing

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

Group Type: ACTIVE_COMPARATOR

Standard Dressing

Intervention Type: DEVICE

This involves standard of care dressing including but not limited to gauze.

Interventions

Prevena

Prevena Incision Management system

Intervention Type: DEVICE

Standard Dressing

This involves standard of care dressing including but not limited to gauze.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kinetic Concepts, Inc.

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimberley Steele, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Medical Institutes

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00030337

Identifier Type: -

Identifier Source: org_study_id