Recruiting

Sternal Dressing

Sponsor:

Stanford University

Code:

NCT03346694

Conditions

Wound of Skin

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard Island Dressing

Prevena Negative Pressure wound dressing

Mepilex Border Post-Op Ag

Study Details

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.

Conditions

Wound of Skin

Study ID

NCT03346694

Start date

May 1, 2018

Status verified date

Oct, 2022

Completion date

May 1, 2035

Anticipated

Primary completion date

May 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

660 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Dressing 1: Standard Island Dressing

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.

active comparator: Dressing 2: Prevena negative pressure

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.

active comparator: Dressing 3: Mepilex Border Post-Op Ag

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.

Interventions

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

Primary outcome measure

  • Rates of surgical site infection pertaining to each dressing studied. [ Time Frame: From Post-Operative date 0 to 7th day or earlier which ever day comes first. ]

Central Contacts and Locations

Central contacts

Jack Boyd, M.D.

650-736-2042jackboyd@stanford.edu

Clarivil Cruz Gonzales, RN

650-542-6532CCruzGonzales@stanfordhealthcare.org

Locations

Stanford Healthcare

Recruiting

Stanford, California, United States, 94305

More Information

Sponsor

Stanford University

Last update posted

Oct 26, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2022-10-26.