Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT03346694
Status
Recruiting
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Conditions

  • Wound of Skin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard Island Dressing — DEVICE
    participant randomized to control group before end of surgery to be applied on cardiovascular heart surgical sternal incision.
  • Prevena Negative Pressure wound dressing — DEVICE
    participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision.
  • Mepilex Border Post-Op Ag — DEVICE
    Participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision

Study Details

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.

Key Dates

Start date
May 1, 2018
Status verified
Oct 2022
Primary completion
May 1, 2030
Completion
May 1, 2035

Study Design

Enrollment
660 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford HealthcareStanfordCalifornia94305-

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