Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

Not Applicable

Recruiting

• Conditions: Wound of Skin
• Interventions: Device: Mepilex Border Post-Op Ag; Device: Standard Island Dressing; Device: Prevena Negative Pressure wound dressing

• Registration Number: NCT03346694
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-15
• Study First Submitted QC: 2017-11-16
• Study First Posted: 2017-11-17
• Study Start: 2018-05-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-26
• Primary Completion: 2030-05-01
• Study Completion: 2035-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 660

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dressing 3: Mepilex Border Post-Op Ag	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.
Dressing 1: Standard Island Dressing	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.
Dressing 2: Prevena negative pressure	Prevena Negative Pressure wound dressing	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Stanford Healthcare; 🇺🇸 Stanford, California, United States