Wound of SkinNCT03346694
Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing
A study testing Standard Island Dressing, Prevena Negative Pressure wound dressing and Mepilex Border Post-Op Ag in people with Wound of Skin, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound of Skin
- What is being tested?
- Standard Island Dressing, Prevena Negative Pressure wound dressing and Mepilex Border Post-Op Ag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 1 May 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients undergoing heart transplants, Ventricular Assist Device (VAD), with postoperative courses complicated by tamponade, take-backs, and open chest incisions will also be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Healthcare
Stanford, California, 94305
About this study
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
- Being tested
- Standard Island Dressing, Prevena Negative Pressure wound dressing, Mepilex Border Post-Op Ag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Island DressingDevice
Also called Dressing 1
participant randomized to control group before end of surgery to be applied on cardiovascular heart surgical sternal incision.
Prevena Negative Pressure wound dressingDevice
Also called Dressing 2
participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision.
Mepilex Border Post-Op AgDevice
Also called Dressing 3
Participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Standard Island Dressing |
| 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. Receives: Device: Prevena Negative Pressure wound dressing |
| 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. Receives: Device: Mepilex Border Post-Op Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Post-Operative date 0 to 7th day or earlier which ever day comes first.
Secondary outcomes (1)
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).
Measured: 30 days after participant discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 May 2018
- Primary completion1 May 2030 (estimated)
- Study completion1 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Wound of SkinStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participant randomly assigned to either a control or one of two intervention groups
- Masking
- None (open label)
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jack Boyd, Stanford University
- Investigators
- Jack Boyd, M.D., Principal investigator, Cardiovascular Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346694
- Sponsor's protocol ID
- 41985
- Status last verified
- Oct 2022
- First submitted
- 15 Nov 2017
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lwanga, S.K. & Lemeshow, S. (1991). Sample size determination in health studies: a practical manual. World Health Organization: Geneva, Switzerland.
R Core Team (2016). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria.
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.
PubMed 26219113Ly, E. (2015). Cardiothoracic (CT) surgery data summary- all surgical site infections by quarter 2015 [PowerPoint slides]. Retrieved from personal communication.
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.
PubMed 26244240
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing
- ClinicalTrials.gov ID
- NCT03346694
- Acronym / sponsor ID
- 41985
- Conditions
- Wound of Skin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 1 May 2035 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participant randomly assigned to either a control or one of two intervention groups
| Arm | Type | Receives |
|---|---|---|
| Dressing 1: Standard Island Dressing | Active comparator | Device: Standard Island DressingStandard 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 | Device: Prevena Negative Pressure wound dressingPrevena 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 | Device: Mepilex Border Post-Op AgMepilex 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients undergoing heart transplants, Ventricular Assist Device (VAD), with postoperative courses complicated by tamponade, take-backs, and open chest incisions will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Island DressingAlso: Dressing 1participant randomized to control group before end of surgery to be applied on cardiovascular heart surgical sternal incision. | Device | Dressing 1: Standard Island Dressing |
| Prevena Negative Pressure wound dressingAlso: Dressing 2participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision. | Device | Dressing 2: Prevena negative pressure |
| Mepilex Border Post-Op AgAlso: Dressing 3Participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision | Device | Dressing 3: Mepilex Border Post-Op Ag |
Primary outcome
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.
evaluate alternative dressings to determine reductions in surgical site infection (SSI) rates among cardiac surgery patients
1 secondary outcome
Impact of alternative dressings on rates of Sternal wound incision infection
Time frame: 30 days after participant discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- BackgroundLwanga, S.K. & Lemeshow, S. (1991). Sample size determination in health studies: a practical manual. World Health Organization: Geneva, Switzerland.
- BackgroundR Core Team (2016). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria.
- Results publication: PubMed 26219113Barnes 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 publicationLy, E. (2015). Cardiothoracic (CT) surgery data summary- all surgical site infections by quarter 2015 [PowerPoint slides]. Retrieved from personal communication.
- Results publication: PubMed 26244240Kles 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.
- A Language and environment for statistical computingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jack Boyd, M.D. principal investigator
Cardiovascular Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Island Dressing, Prevena Negative Pressure wound dressing and Mepilex Border Post-Op Ag in people with Wound of Skin, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jack Boyd, M.D. (650-736-2042, jackboyd@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03346694, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.