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NCT02020018 Clinical Trial

Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection

Surgical Wound Infection Clinical Trial

Official title:
Negative Pressure Wound Therapy for Prevention of Wound Infection After Heart Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02020018
Other study ID # 16-007901
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2013
Est. completion date October 2018

Study information
Verified date November 2019
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1869
Est. completion date October 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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:
• Conventional sterile dry wound dressing
regular dressing that is applied immediately postoperatively for high risk patients in the operating room after sternotomy

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic KCI USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Length of Stay Length of stay was defined as the number of nights spent in the hospital after surgery. postoperative to discharge
Primary Wound Infection After Open Heart Surgery The total number of participants with surgical site infections after cardiac surgery. 30 days post-surgery
Secondary Reoperation for Wound Infection The total number of reoperations required due to infection. 30 days post surgery
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