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Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

Primary Purpose

Wound of Skin

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Island Dressing
Prevena Negative Pressure wound dressing
Mepilex Border Post-Op Ag
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound of Skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford HealthcareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Dressing 1: Standard Island Dressing

Dressing 2: Prevena negative pressure

Dressing 3: Mepilex Border Post-Op Ag

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
November 15, 2017
Last Updated
October 24, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03346694
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
May 1, 2030 (Anticipated)
Study Completion Date
May 1, 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound of Skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participant randomly assigned to either a control or one of two intervention groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
660 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dressing 1: Standard Island Dressing
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dressing 2: Prevena negative pressure
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dressing 3: Mepilex Border Post-Op Ag
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Standard Island Dressing
Other Intervention Name(s)
Dressing 1
Intervention Description
participant randomized to control group before end of surgery to be applied on cardiovascular heart surgical sternal incision.
Intervention Type
Device
Intervention Name(s)
Prevena Negative Pressure wound dressing
Other Intervention Name(s)
Dressing 2
Intervention Description
participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision.
Intervention Type
Device
Intervention Name(s)
Mepilex Border Post-Op Ag
Other Intervention Name(s)
Dressing 3
Intervention Description
Participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision
Primary Outcome Measure Information:
Title
Rates of surgical site infection pertaining to each dressing studied.
Description
evaluate alternative dressings to determine reductions in surgical site infection (SSI) rates among cardiac surgery patients
Time Frame
From Post-Operative date 0 to 7th day or earlier which ever day comes first.
Secondary Outcome Measure Information:
Title
Impact of alternative dressings on rates of Sternal wound incision infection
Description
Assess the impact of alternative dressing use on hospital 30-day readmission rates related to surgical site infection (SSI).
Time Frame
30 days after participant discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jack Boyd, M.D.
Phone
650-736-2042
Email
jackboyd@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Clarivil Cruz Gonzales, RN
Phone
650-542-6532
Email
CCruzGonzales@stanfordhealthcare.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack Boyd, M.D.
Organizational Affiliation
Cardiovascular Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Healthcare
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Lwanga, S.K. & Lemeshow, S. (1991). Sample size determination in health studies: a practical manual. World Health Organization: Geneva, Switzerland.
Results Reference
background
Citation
R Core Team (2016). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria.
Results Reference
background
PubMed Identifier
26219113
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.
Results Reference
result
Citation
Ly, E. (2015). Cardiothoracic (CT) surgery data summary- all surgical site infections by quarter 2015 [PowerPoint slides]. Retrieved from personal communication.
Results Reference
result
PubMed Identifier
26244240
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.
Results Reference
result
Links:
URL
https://www.R-project.org/
Description
A Language and environment for statistical computing

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Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

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