Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

Study Overview
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Brief Summary
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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.

Official Title
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Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

Conditions
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Wound of Skin

Intervention / Treatment
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* Device: Standard Island Dressing
* Device: Prevena Negative Pressure wound dressing
* Device: Mepilex Border Post-Op Ag


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dressing 1: Standard Island Dressing<br>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<br>* participant randomized to control group before end of surgery to be applied on cardiovascular heart surgical sternal incision.<br>* Other names: Dressing 1;|
| Active Comparator: Dressing 2: Prevena negative pressure<br>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<br>* participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision.<br>* Other names: Dressing 2;|
| Active Comparator: Dressing 3: Mepilex Border Post-Op Ag<br>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<br>* Participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision<br>* Other names: Dressing 3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From Post-Operative date 0 to 7th day or earlier which ever day comes first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 30 days after participant discharge. |