Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

ConditionWound of Skin

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients undergoing heart transplants, Ventricular Assist Device (VAD), with postoperative courses complicated by tamponade, take-backs, and open chest incisions will also be excluded.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

660 Participants

are divided into 3 treatment groups

Group A: Dressing 1: Standard Island DressingActive comparator 1 intervention

Group B: Dressing 2: Prevena negative pressureActive comparator 1 intervention

Group C: Dressing 3: Mepilex Border Post-Op AgActive comparator 1 intervention

Trial outcomes

Primary outcomes

Rates of surgical site infection pertaining to each dressing studied.

evaluate alternative dressings to determine reductions in surgical site infection (SSI) rates among cardiac surgery patients

Time frame

From Post-Operative date 0 to 7th day or earlier which ever day comes first.

Secondary outcomes

Impact of alternative dressings on rates of Sternal wound incision infection

Assess the impact of alternative dressing use on hospital 30-day readmission rates related to surgical site infection (SSI).

Time frame

30 days after participant discharge.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov

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