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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Postoperative Complications; Wound Infection, Surgical
• Intervention / Treatment: Device: Prevena; Device: Standard 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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Medical Institutes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Prevena; After surgery this group will receive the Prevena device (negative pressure wound therapy).	Device: Prevena; Prevena Incision Management system
ACTIVE_COMPARATOR: Standard dressing; After surgery this group will receive standard of care dressings on their surgical wound.	Device: Standard Dressing; This involves standard of care dressing including but not limited to gauze.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines	The incidence of postoperative surgical site infection (according to National Healthcare Safety Network - Center for Disease Control guidelines) in open surgery	Up to 7 days postop

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other Wound Complications (Aggregate)	Dehiscence, seroma and hematoma. Reported as number of aggregate events.	Up to 14 days postop
Skin Bacterial Count as Assessed by Microbacterial Count	Skin bacterial count after removal of either Prevena or standard dressing. A micro-bacterial swap will be performed and sent to the microbiology lab for assessing bacterial count	Up to 7 days postop
Physical Function as Assessed by Short Form Survey (SF) 36	The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability	Up to 14 days postop
Readmissions	Readmission events for the patients.	Up to 30 days postop
Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36	The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability	Up to 14 days postop
Social Functioning as Assessed by Short Form Survey (SF) 36	The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability	Up to 14 days postop
Energy / Fatigue as Assessed by Short Form Survey (SF) 36	The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Energy and fatigue are aggregated in this section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability	Up to 14 days postop
Emotional Well Being as Assessed by Short Form Survey (SF) 36	The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability	Up to 14 days postop
Pain as Assessed by Short Form Survey (SF) 36	The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability	Up to 14 days postop
General Health as Assessed by Short Form Survey (SF) 36	The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability	Up to 14 days postop

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Kinetic Concepts, Inc.
• Investigators: Principal Investigator: Kimberley Steele, MD, PHD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2015
• Primary Completion (ACTUAL): March 1, 2017
• Study Completion (ACTUAL): March 1, 2017

Study Registration Dates

• First Submitted: June 1, 2015
• First Submitted That Met QC Criteria: June 2, 2015
• First Posted (ESTIMATE): June 3, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Obesity; Obese; surgical site infection; negative pressure therapy; closed incisions
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Wounds and Injuries; Postoperative Complications; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: IRB00030337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes