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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

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

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

NCT ID

NCT03346694

First Posted

November 15, 2017

Last Updated

October 24, 2022

Sponsor

Stanford University

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

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

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

Arm Title

Dressing 2: Prevena negative pressure

Arm Type

Active Comparator

Arm Description

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

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

jackboyd@stanford.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Clarivil Cruz Gonzales, RN

Phone

650-542-6532

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

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

Learn more about this trial

Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

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