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Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03346694
Enrollment
660
Registered
2017-11-17
Start date
2018-05-01
Completion date
2035-05-01
Last updated
2022-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound of Skin

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.

Interventions

DEVICEStandard Island Dressing

participant randomized to control group before end of surgery to be applied on cardiovascular heart surgical sternal incision.

DEVICEPrevena Negative Pressure wound dressing

participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision.

Participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participant randomly assigned to either a control or one of two intervention groups

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Impact of alternative dressings on rates of Sternal wound incision infection30 days after participant discharge.Assess the impact of alternative dressing use on hospital 30-day readmission rates related to surgical site infection (SSI).

Countries

United States

Contacts

Primary ContactJack Boyd, M.D.
jackboyd@stanford.edu650-736-2042
Backup ContactClarivil Cruz Gonzales, RN
CCruzGonzales@stanfordhealthcare.org650-542-6532

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026