Skip to main content
OpenTrials
Completed

NCT Number: NCT02020018

Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgical Wound Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Wound Infection

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Transplant patients
  • BMI >30
  • Type I (insulin-dependent) diabetics
  • Severe chronic obstructive pulmonary disease (COPD)
  • Steroid-dependent patients
  • Previous Tracheostomy

Exclusion criteria

  • BMI<30
  • Thoracotomy

Treatment and study plan

Prevena Incision Management System

Device

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: negative pressure therapy, wound VAC, Prevena

Conventional sterile dry wound dressing

Other

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

Primary outcomes

  1. Wound Infection After Open Heart Surgery

    Time frame: 30 days post-surgery

    The total number of participants with surgical site infections after cardiac surgery.

Secondary outcomes

  1. Reoperation for Wound Infection

    Time frame: 30 days post surgery

    The total number of reoperations required due to infection.

Other outcomes

  1. Length of Stay

    Time frame: postoperative to discharge

    Length of stay was defined as the number of nights spent in the hospital after surgery.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • KCI USA, Inc

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 24, 2013
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.