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Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03346694
Recruitment Status : Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Jack Boyd, Stanford University

Study Description
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Brief Summary:
This study will evaluate two alternative dressings compared to a standard Island dressing presently in use at Stanford Hospital to determine reductions in surgical site infection (SSI) rates among cardiac surgery patients. Cardiovascular surgery patients who will have a sternotomy incision as a routine part of their surgery will be approached to voluntarily participate. Participants will be randomized to one of three dressing to determine which dressing has the lowest rate of sternal wound infection. The investigators will also assess the impact of alternative dressing use on hospital 30-day readmission rates related to SSI.

Condition or disease Intervention/treatment Phase
Wound of Skin Device: Standard Island Dressing Device: Prevena Negative Pressure wound dressing Device: Mepilex Border Post-Op Ag Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participant randomly assigned to either a control or one of two intervention groups
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dressing 1: Standard Island Dressing
Standard dressing that is applied on most patients with a sternotomy wound incision immediately after cardiovascular surgery before leaving the operating room. Dressing will be removed 48 hours after surgery.
 Device: Standard Island Dressing
participant randomized to control group before end of surgery to be applied on cardiovascular heart surgical sternal incision.
Other Name: Dressing 1
Active Comparator: Dressing 2: Prevena negative pressure
Prevena negative pressure wound suction machine dressing applied to sternotomy wound incision immediately after cardiovascular surgery. Dressing will be in use for 7 days or removed sooner if participant is discharged before end of 7 day post-operative time period.
 Device: Prevena Negative Pressure wound dressing
participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision.
Other Name: Dressing 2
Active Comparator: Dressing 3: Mepilex Border Post-Op Ag
Mepilex Border PostOp AG dressing impregnated with silver ions. Dressing will be in use for 7 days or removed earlier if patient is discharged before end of 7 days post0operative time period.
 Device: Mepilex Border Post-Op Ag
Participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision
Other Name: Dressing 3


Outcome Measures
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Primary Outcome Measures :
  1. Rates of surgical site infection pertaining to each dressing studied. [ Time Frame: From Post-Operative date 0 to 7th day or earlier which ever day comes first. ]
    evaluate alternative dressings to determine reductions in surgical site infection (SSI) rates among cardiac surgery patients


Secondary Outcome Measures :
  1. Impact of alternative dressings on rates of Sternal wound incision infection [ Time Frame: 30 days after participant discharge. ]
    Assess the impact of alternative dressing use on hospital 30-day readmission rates related to surgical site infection (SSI).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who will undergo cardiac surgery via a sternotomy incision.Inclusion criteria will be patients having surgical valve, CABGs, aortic dissection, myectomy and myotomy, Cox MAZE, Myocardial bridge Un-roofing

Exclusion Criteria:

  • Patients undergoing heart transplants, Ventricular Assist Device (VAD), with postoperative courses complicated by tamponade, take-backs, and open chest incisions will also be excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346694


Locations
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United States, California
Stanford Healthcare
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Jack Boyd, M.D. Cardiovascular Surgeon
More Information
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Additional Information:

Publications of Results:
Ly, E. (2015). Cardiothoracic (CT) surgery data summary- all surgical site infections by quarter 2015 [PowerPoint slides]. Retrieved from personal communication.

Other Publications:
Lwanga, S.K. & Lemeshow, S. (1991). Sample size determination in health studies: a practical manual. World Health Organization: Geneva, Switzerland.
R Core Team (2016). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria.

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Responsible Party: Jack Boyd, Prinicipal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT03346694    
Other Study ID Numbers: 41985
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Surgical Wound Infection
Infections
Wound Infection
Postoperative Complications
Pathologic Processes