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Recruiting

NCT Number: NCT03346694

Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

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.

Recruiting

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Key information

Conditions

Wound of Skin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Healthcare

Stanford, California, 94305, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Island Dressing

Device

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

Other names: Dressing 1

Prevena Negative Pressure wound dressing

Device

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

Other names: Dressing 2

Mepilex Border Post-Op Ag

Device

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

Other names: Dressing 3

Primary outcomes

  1. Rates of surgical site infection pertaining to each dressing studied.

    Time frame: 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 outcomes

  1. Impact of alternative dressings on rates of Sternal wound incision infection

    Time frame: 30 days after participant discharge.

    Assess the impact of alternative dressing use on hospital 30-day readmission rates related to surgical site infection (SSI).

Study contacts

Contact information is provided by the study sponsor or research team.

Clarivil Cruz Gonzales, RN

CONTACT

[email protected]

650-542-6532

Jack Boyd, M.D.

CONTACT

[email protected]

650-736-2042

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2018
Primary completion
2030
Study completion
2035
First posted
Nov 17, 2017
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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