Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing
1 other identifier
interventional
660
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2035
October 26, 2022
October 1, 2022
12 years
November 15, 2017
October 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Rates of surgical site infection pertaining to each dressing studied.
evaluate alternative dressings to determine reductions in surgical site infection (SSI) rates among cardiac surgery patients
From Post-Operative date 0 to 7th day or earlier which ever day comes first.
Secondary Outcomes (1)
Impact of alternative dressings on rates of Sternal wound incision infection
30 days after participant discharge.
Study Arms (3)
Dressing 1: Standard Island Dressing
ACTIVE COMPARATORStandard 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.
Dressing 2: Prevena negative pressure
ACTIVE COMPARATORPrevena 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.
Dressing 3: Mepilex Border Post-Op Ag
ACTIVE COMPARATORMepilex 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.
Interventions
participant randomized to control group 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.
Participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision
Eligibility Criteria
You may not qualify if:
- Patients undergoing heart transplants, Ventricular Assist Device (VAD), with postoperative courses complicated by tamponade, take-backs, and open chest incisions will also be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford Healthcare
Stanford, California, 94305, United States
Related Publications (5)
Lwanga, S.K. & Lemeshow, S. (1991). Sample size determination in health studies: a practical manual. World Health Organization: Geneva, Switzerland.
BACKGROUNDR Core Team (2016). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria.
BACKGROUNDBarnes 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.
PMID: 26219113RESULTLy, E. (2015). Cardiothoracic (CT) surgery data summary- all surgical site infections by quarter 2015 [PowerPoint slides]. Retrieved from personal communication.
RESULTKles 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.
PMID: 26244240RESULT
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Jack Boyd, M.D.
Cardiovascular Surgeon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicipal Investigator
Study Record Dates
First Submitted
November 15, 2017
First Posted
November 17, 2017
Study Start
May 1, 2018
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
May 1, 2035
Last Updated
October 26, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share