Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dressing 1: Standard Island Dressing | Active Comparator | 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. |
|
| Dressing 2: Prevena negative pressure | Active Comparator | 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. |
|
| Dressing 3: Mepilex Border Post-Op Ag | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Island Dressing | Device | participant randomized to control group before end of surgery to be applied on cardiovascular heart surgical sternal incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jack Boyd, M.D. | Contact | 650-736-2042 | jackboyd@stanford.edu | |
| Clarivil Cruz Gonzales, RN | Contact | 650-542-6532 | CCruzGonzales@stanfordhealthcare.org |
| Name | Affiliation | Role |
|---|---|---|
| Jack Boyd, M.D. | Cardiovascular Surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Healthcare | Recruiting | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Lwanga, S.K. & Lemeshow, S. (1991). Sample size determination in health studies: a practical manual. World Health Organization: Geneva, Switzerland. | ||
| Background | R Core Team (2016). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. | ||
| 26219113 | Result | 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. | |
| Result | Ly, E. (2015). Cardiothoracic (CT) surgery data summary- all surgical site infections by quarter 2015 [PowerPoint slides]. Retrieved from personal communication. | ||
| Label | URL |
|---|---|
| A Language and environment for statistical computing | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participant randomly assigned to either a control or one of two intervention groups
Not provided
Not provided
Not provided
Not provided
|
| Prevena Negative Pressure wound dressing | Device | participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision. |
|
|
| Mepilex Border Post-Op Ag | Device | Participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision |
|
|
| Result |
| 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. |