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Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

NCT03346694 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2022-10-26

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Jack Boyd, M.D. · Cardiovascular Surgeon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2030-05-01
Completion
2035-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03346694 on ClinicalTrials.gov