Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

Wound of Skin Clinical Trial

Official title:

Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03346694
• Other study ID #: 41985
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: May 1, 2035

Study information

• Verified date: October 2022
• Source: Stanford University
• Contact: Jack Boyd, M.D.
• Phone: 650-736-2042
• Email: jackboyd[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: May 1, 2035
• Est. primary completion date: May 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Wound Infection
• Wound of Skin

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Stanford Healthcare	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Barnes S. What's new in SSI prevention? AORN J. 2015 Jun;101(6):P10-2. — View 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 — View Citation

Lwanga, S.K. & Lemeshow, S. (1991). Sample size determination in health studies: a practical manual. World Health Organization: Geneva, Switzerland.

Ly, E. (2015). Cardiothoracic (CT) surgery data summary- all surgical site infections by quarter 2015 [PowerPoint slides]. Retrieved from personal communication.

R Core Team (2016). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impact of alternative dressings on rates of Sternal wound incision infection	Assess the impact of alternative dressing use on hospital 30-day readmission rates related to surgical site infection (SSI).	30 days after participant discharge.

External Links

•   A Language and environment for statistical computing