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Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

Sponsor
Stanford University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03346694
Collaborator
(none)
660
Enrollment
1
Location
3
Arms
48
Anticipated Duration (Months)
13.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Standard Island Dressing
  • Device: Prevena Negative Pressure wound dressing
  • Device: Mepilex Border Post-Op Ag
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
660 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participant randomly assigned to either a control or one of two intervention groupsParticipant 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
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • Dressing 3

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rates of surgical site infection pertaining to each dressing studied. [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Stanford Healthcare Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Jack Boyd, M.D., Cardiovascular Surgeon

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Jack Boyd, Prinicipal Investigator, Stanford University
    ClinicalTrials.gov Identifier:
    NCT03346694
    Other Study ID Numbers:
    • 41985
    First Posted:
    Nov 17, 2017
    Last Update Posted:
    Mar 17, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Surgical Wound Infection

    Study Results

    No Results Posted as of Mar 17, 2021