NCT03346694

Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 660 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound of Skin

Interventions

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

Timeline

• Start date: 2018-05-01
• Primary completion: 2030-05-01
• Completion: 2035-05-01
• First posted: 2017-11-17
• Last updated: 2022-10-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study