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Alternative Dressings for Surgical Site Infections

N/A

Recruiting

Led By Jack Boyd, M.D.

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after participant discharge.

Awards & highlights

Study Summary

This trial will compare two types of wound dressings to the standard for reducing surgical site infections (SSI) in heart surgery patients.

Who is the study for?

This trial is for cardiac surgery patients at Stanford Hospital who will have a sternotomy incision. It's open to those having valve surgeries, CABGs, and several other specific heart procedures. However, it excludes heart transplant recipients, patients with Ventricular Assist Devices (VAD), or complications like tamponade or open chest after surgery.Check my eligibility

What is being tested?

The study compares two alternative dressings—Mepilex Border Post-Op Ag and Prevena Negative Pressure—with the standard Island dressing to see which reduces surgical site infection rates post-cardiac surgery. The impact on hospital readmission rates within 30 days due to infections is also being assessed.See study design

What are the potential side effects?

While the trial description does not specify side effects, potential issues could include skin irritation or allergic reactions to dressing materials, discomfort from negative pressure therapy, or less effective wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for heart surgery that involves opening my chest.

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I have had heart surgery, such as valve replacement or bypass.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after participant discharge.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after participant discharge.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after participant discharge. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rates of surgical site infection pertaining to each dressing studied.

Secondary outcome measures

Impact of alternative dressings on rates of Sternal wound incision infection

Trial Design

3Treatment groups

Active Control

Group I: Dressing 1: Standard Island DressingActive Control1 Intervention

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.

Group II: Dressing 3: Mepilex Border Post-Op AgActive Control1 Intervention

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.

Group III: Dressing 2: Prevena negative pressureActive Control1 Intervention

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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,340,690 Total Patients Enrolled

Jack Boyd, M.D.Principal InvestigatorCardiovascular Surgeon

Media Library

Standard Island Dressing Clinical Trial Eligibility Overview. Trial Name: NCT03346694 — N/A

Skin Wound Research Study Groups: Dressing 1: Standard Island Dressing, Dressing 3: Mepilex Border Post-Op Ag, Dressing 2: Prevena negative pressure

Skin Wound Clinical Trial 2023: Standard Island Dressing Highlights & Side Effects. Trial Name: NCT03346694 — N/A

Standard Island Dressing 2023 Treatment Timeline for Medical Study. Trial Name: NCT03346694 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still being admitted to this clinical trial?

"Affirmative. The clinical trial is still seeking participants, as attested by the records on clinicaltrials.gov which reveal that it was first published in May 1st 2018 and last refreshed October 24th 2022."

Answered by AI

What is the current number of participants for this medical trial?

"Affirmative. Clinicaltrials.gov offers evidence that this clinical trial is still searching for volunteers, which was initially announced on May 1st 2018 and modified lastly on October 24th 2022. To date, 660 individuals will be accepted at one centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

Jack Boyd 2018. "Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03346694.