Back to resultsNegative Pressure Wound Therapy for Prevention of Poststernotomy Infection
Primary Purpose
Surgical Wound Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prevena Incision Management System
Conventional sterile dry wound dressing
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Infection
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prospective group
Retrospective arm
Arm Description
Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.
Conventional sterile dry wound dressing applied immediately postoperatively.
Outcomes
Primary Outcome Measures
Wound Infection After Open Heart Surgery
The total number of participants with surgical site infections after cardiac surgery.
Secondary Outcome Measures
Reoperation for Wound Infection
The total number of reoperations required due to infection.
Full Information
NCT ID
NCT02020018
First Posted
December 18, 2013
Last Updated
November 5, 2019
Sponsor
Mayo Clinic
Collaborators
3M
1. Study Identification
Unique Protocol Identification Number
NCT02020018
Brief Title
Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection
Official Title
Negative Pressure Wound Therapy for Prevention of Wound Infection After Heart Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
3M
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1869 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prospective group
Arm Type
Experimental
Arm Description
Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.
Arm Title
Retrospective arm
Arm Type
Active Comparator
Arm Description
Conventional sterile dry wound dressing applied immediately postoperatively.
Intervention Type
Device
Intervention Name(s)
Prevena Incision Management System
Other Intervention Name(s)
negative pressure therapy, wound VAC, Prevena
Intervention Description
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
Other
Intervention Name(s)
Conventional sterile dry wound dressing
Other Intervention Name(s)
poststernotomy wound dressing, standard dressing after sternotomy
Intervention Description
regular dressing that is applied immediately postoperatively for high risk patients in the operating room after sternotomy
Primary Outcome Measure Information:
Title
Wound Infection After Open Heart Surgery
Description
The total number of participants with surgical site infections after cardiac surgery.
Time Frame
30 days post-surgery
Secondary Outcome Measure Information:
Title
Reoperation for Wound Infection
Description
The total number of reoperations required due to infection.
Time Frame
30 days post surgery
Other Pre-specified Outcome Measures:
Title
Length of Stay
Description
Length of stay was defined as the number of nights spent in the hospital after surgery.
Time Frame
postoperative to discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hartzell V Schaff, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection
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