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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participant randomly assigned to either a control or one of two intervention groups
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Stanford Healthcare
Stanford 5398563, California 5332921 94305

More Details

Status
Recruiting
Sponsor
Stanford University

Study Contact

Jack Boyd, M.D.
650-736-2042
jackboyd@stanford.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.