Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection

November 5, 2019 updated by: Hartzell V. Schaff, Mayo Clinic

Negative Pressure Wound Therapy for Prevention of Wound Infection After Heart Surgery

This prospective study evaluates the role of negative pressure wound therapy or wound VAC as a dressing over the incision to prevent poststernotomy wound infection in high risk patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Surgical site infection after cardiac surgery is a major cause for increased morbidity and mortality. Vacuum assisted closure (VAC) has been used in the management of open and infected wounds. However, its effectiveness as a prophylactic measure for prevention of surgical site infection after routine cardiac surgery is unknown.

Study Type

Interventional

Enrollment (Actual)

1869

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Transplant patients
  2. BMI >30
  3. Type I (insulin-dependent) diabetics
  4. Severe chronic obstructive pulmonary disease (COPD)
  5. Steroid-dependent patients
  6. Previous Tracheostomy

Exclusion criteria:

  1. BMI<30
  2. Thoracotomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prospective group
Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.
Device: Prevena Incision Management System
negative pressure therapy that will be applied instead of the regular dressing immediately postoperatively in high risk patients and kept for 6-7 days
Other Names:
  • Prevena
  • negative pressure therapy
  • wound VAC
Active Comparator: Retrospective arm
Conventional sterile dry wound dressing applied immediately postoperatively.
Other: Conventional sterile dry wound dressing
regular dressing that is applied immediately postoperatively for high risk patients in the operating room after sternotomy
Other Names:
  • poststernotomy wound dressing
  • standard dressing after sternotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Infection After Open Heart Surgery
Time Frame: 30 days post-surgery
The total number of participants with surgical site infections after cardiac surgery.
30 days post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation for Wound Infection
Time Frame: 30 days post surgery
The total number of reoperations required due to infection.
30 days post surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay
Time Frame: postoperative to discharge
Length of stay was defined as the number of nights spent in the hospital after surgery.
postoperative to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

3M

Investigators

  • Principal Investigator: Hartzell V Schaff, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

December 18, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Actual)

November 6, 2019

Last Update Submitted That Met QC Criteria

November 5, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-007901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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