Clinical trial NCT03346694: Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing
Official title: Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wound of Skin
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participant randomly assigned to either a control or one of two intervention groups
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rates of surgical site infection pertaining to each dressing studied.
timeFrame: From Post-Operative date 0 to 7th day or earlier which ever day comes first.
Secondary outcomes:
measure: Impact of alternative dressings on rates of Sternal wound incision infection
timeFrame: 30 days after participant discharge.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Healthcare
state: California
Study officials:
affiliation: Cardiovascular Surgeon
name: Jack Boyd, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lwanga, S.K. & Lemeshow, S. (1991). Sample size determination in health studies: a practical manual. World Health Organization: Geneva, Switzerland.
citation: R Core Team (2016). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria.
citation: 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.
citation: Ly, E. (2015). Cardiothoracic (CT) surgery data summary- all surgical site infections by quarter 2015 [PowerPoint slides]. Retrieved from personal communication.
citation: 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.