What's new in SSI prevention?
Sue Barnes
https://pubmed.ncbi.nlm.nih.gov/26219113Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID03346694
Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing
Led by Stanford University · Updated on 2022-10-26
660
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two alternative sternal dressings compared to the standard Island dressing to reduce surgical site infection rates in patients undergoing cardiac surgery with a sternotomy incision. The study aims to identify which dressing leads to the lowest rate of sternal wound infection and also examines the impact of these dressings on hospital readmission rates related to infections within 30 days after surgery. Participants will be randomly assigned to receive one of three dressings applied immediately after their cardiovascular surgery: the standard Island dressing, the Prevena negative pressure wound suction dressing, or the Mepilex Border Post-Op Ag dressing impregnated with silver ions. The standard dressing is removed 48 hours after surgery, while the Prevena and Mepilex dressings remain in place for up to 7 days or until patient discharge if earlier. During the study, participants will be monitored for surgical site infections from the day of surgery up to 7 days post-operation or until discharge, whichever comes first. Researchers will also track infection rates at the sternal incision site and related hospital readmissions up to 30 days after discharge. The study involves follow-up assessments to evaluate the safety and effectiveness of each dressing over time.
CONDITIONS
Brief Title
Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Participants who will undergo cardiac surgery via a sternotomy incision
- Patients having surgical valve, CABGs, aortic dissection, myectomy and myotomy, Cox MAZE, Myocardial bridge Un-roofing procedures
You will not qualify if you...
- Patients undergoing heart transplants
- Patients with Ventricular Assist Devices (VAD)
- Patients with postoperative complications such as tamponade, take-backs, or open chest incisions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Surgery day plus up to 7 days post-operative
Participants undergo cardiovascular surgery with a sternotomy incision, and a randomized dressing is applied immediately after surgery in the operating room.
Dressing removal visit 48 hours after surgery for Standard Island Dressing; dressing remains up to 7 days or until discharge for other dressings
Post-operative Follow-up
Duration - Up to 30 days after discharge
Participants are monitored for surgical site infections and healing after discharge, up to 30 days post-discharge.
Follow-up visits as scheduled for wound assessment
Trial Site Locations
Total: 1 location
1
Stanford Healthcare
Stanford, California, United States, 94305
Actively Recruiting
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Research Team
J
Jack Boyd, M.D.
C
Clarivil Cruz Gonzales, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Achieving and Sustaining Zero: Preventing Surgical Site Infections After Isolated Coronary Artery Bypass With Saphenous Vein Harvest Site Through Implementation of a Staff-Driven Quality Improvement Process.
Candis Lee Kles, C Patrick Murrah, Kerry Smith...
https://pubmed.ncbi.nlm.nih.gov/26244240