Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1869 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgical Wound Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prospective group

Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.

Group Type EXPERIMENTAL

Prevena Incision Management System

Intervention Type 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

Retrospective arm

Conventional sterile dry wound dressing applied immediately postoperatively.

Group Type ACTIVE_COMPARATOR

Conventional sterile dry wound dressing

Intervention Type OTHER

regular dressing that is applied immediately postoperatively for high risk patients in the operating room after sternotomy

Interventions

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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

Intervention Type DEVICE

Conventional sterile dry wound dressing

regular dressing that is applied immediately postoperatively for high risk patients in the operating room after sternotomy

Intervention Type OTHER

Other Intervention Names

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negative pressure therapy wound VAC Prevena poststernotomy wound dressing standard dressing after sternotomy

Eligibility Criteria

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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