Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing
NCT ID: NCT03346694
Last Updated: 2022-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
660 participants
INTERVENTIONAL
2018-05-01
2035-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dressing 1: Standard Island Dressing
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.
Standard Island Dressing
participant randomized to control group before end of surgery to be applied on cardiovascular heart surgical sternal incision.
Dressing 2: Prevena negative pressure
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.
Prevena Negative Pressure wound dressing
participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision.
Dressing 3: Mepilex Border Post-Op Ag
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.
Mepilex Border Post-Op Ag
Participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision
Interventions
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Standard Island Dressing
participant randomized to control group before end of surgery to be applied on cardiovascular heart surgical sternal incision.
Prevena Negative Pressure wound dressing
participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision.
Mepilex Border Post-Op Ag
Participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Jack Boyd
Prinicipal Investigator
Principal Investigators
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Jack Boyd, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Surgeon
Locations
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Stanford Healthcare
Stanford, California, United States
Countries
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Central Contacts
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References
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Lwanga, S.K. & Lemeshow, S. (1991). Sample size determination in health studies: a practical manual. World Health Organization: Geneva, Switzerland.
R Core Team (2016). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria.
Barnes S. What's new in SSI prevention? AORN J. 2015 Jun;101(6):P10-2. doi: 10.1016/s0001-2092(15)00421-4. No abstract available.
Ly, E. (2015). Cardiothoracic (CT) surgery data summary- all surgical site infections by quarter 2015 [PowerPoint slides]. Retrieved from personal communication.
Kles CL, Murrah CP, Smith K, Baugus-Wellmeier E, Hurry T, Morris CD. 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. Dimens Crit Care Nurs. 2015 Sep-Oct;34(5):265-72. doi: 10.1097/DCC.0000000000000131.
Related Links
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A Language and environment for statistical computing
Other Identifiers
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41985
Identifier Type: -
Identifier Source: org_study_id
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