INFECTIONPhase 2SWINCT02374853
Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)
A Phase 2 study testing Vancomycin and No Vancomycin in people with INFECTION, run by University of Alberta.
Trial summary
The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- INFECTION
- What is being tested?
- Vancomycin and No Vancomycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,037 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Apr 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Able to sign Informed Consent and Release of Medical Information Form
- Age ≥ 18 years
- Undergoing cardiac surgery with complete sternotomy (including re-operations)
Who cannot join
- Evidence of active infection (any culture positive or blood positive infection)
- Undergoing organ transplantation
- Patients with known hypersensitivity to vancomycin
- Pregnant or nursing women
- Mental impairment or other conditions that may not allow participant to understand the nature, significance, and scope of study
About this study
The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection.
Read the detailed description
During open-heart surgery, an incision is made along the chest and the sternum (breastbone) is divided. The sternum is held open throughout the surgery so that the doctors can reach the heart. Sternal wound infection is an uncommon but serious complication of cardiac surgery that occurs when an infection develops at this site of entry. Sternal wound infections are associated with increased hospital stays, subsequent surgical procedures, and higher mortality rates.
The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection. The results of this study could provide important information to guide new standards of practice in cardiac surgery. The ultimate goal of this research project is to improve patient care by reducing the number of sternal wound infections at our hospital.
- Conditions
- INFECTION
- Being tested
- Vancomycin, No Vancomycin
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Also called Vancomycin Hydrochloride
Topical prophylactic antibiotic
No VancomycinOther
Also called Sterile water
Placebo: Sterile water. No Vancomycin.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin | Experimental | During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in the following solution: 5 g vancomycin dissolved in 50 mL sterile water Receives: Drug: Vancomycin |
| Control | Placebo comparator | During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in 50 mL sterile water. No Vancomycin Receives: Other: No Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Sternal Wound Infections
The number of sternal wound infections at 3 months postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections.
Measured: 3 months postoperative
Secondary outcomes (5)
Number of Sternal Wound Infections
The number of sternal wound infections at 1 year postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections.
Measured: 1 year postoperative
Hospitalization
Duration of index hospitalization and subsequent re-admissions due to sternal wound infection.
Measured: 1 year postoperative
Number of Participants With Use of Prophylactic Antibiotics
Number of participants with use of prophylactic antibiotics before surgery
Measured: Assessed before surgery
Cost Analysis for Sternal Wound Infection Treatment
Cost analysis for sternal wound infection treatment post-operatively
Measured: 1 year postoperative
Adverse Events
Adverse events during study participation
Measured: 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2019
- Study completionApr 2019
Why it stopped: the preliminary analysis of study result did not show significant benefit that was anticipate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for INFECTIONStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,037 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abbas Khani-Hanjani, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374853
- Sponsor's protocol ID
- SWI-01-14
- Acronym
- SWI
- Status last verified
- Aug 2022
- First submitted
- 23 Feb 2015
- Last updated
- 3 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)
- ClinicalTrials.gov ID
- NCT02374853
- Acronym / sponsor ID
- SWI / SWI-01-14
- Conditions
- INFECTION
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the preliminary analysis of study result did not show significant benefit that was anticipate
- Enrolment
- 1,037 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Posted 3 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection.
Detailed description
During open-heart surgery, an incision is made along the chest and the sternum (breastbone) is divided. The sternum is held open throughout the surgery so that the doctors can reach the heart. Sternal wound infection is an uncommon but serious complication of cardiac surgery that occurs when an infection develops at this site of entry. Sternal wound infections are associated with increased hospital stays, subsequent surgical procedures, and higher mortality rates.
The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection. The results of this study could provide important information to guide new standards of practice in cardiac surgery. The ultimate goal of this research project is to improve patient care by reducing the number of sternal wound infections at our hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin | Experimental | Drug: VancomycinDuring open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in the following solution: 5 g vancomycin dissolved in 50 mL sterile water |
| Control | Placebo comparator | Other: No VancomycinDuring open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in 50 mL sterile water. No Vancomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to sign Informed Consent and Release of Medical Information Form
- Age ≥ 18 years
- Undergoing cardiac surgery with complete sternotomy (including re-operations)
Key exclusion criteria (5 listed)
- Evidence of active infection (any culture positive or blood positive infection)
- Undergoing organ transplantation
- Patients with known hypersensitivity to vancomycin
- Pregnant or nursing women
- Mental impairment or other conditions that may not allow participant to understand the nature, significance, and scope of study
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 |
|---|---|---|
| VancomycinAlso: Vancomycin HydrochlorideTopical prophylactic antibiotic | Drug | Vancomycin |
| No VancomycinAlso: Sterile waterPlacebo: Sterile water. No Vancomycin. | Other | Control |
Primary outcome
Number of Sternal Wound Infections
Time frame: 3 months postoperative
The number of sternal wound infections at 3 months postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections.
5 secondary outcomes
Number of Sternal Wound Infections
Time frame: 1 year postoperative
Hospitalization
Time frame: 1 year postoperative
Number of Participants With Use of Prophylactic Antibiotics
Time frame: Assessed before surgery
Cost Analysis for Sternal Wound Infection Treatment
Time frame: 1 year postoperative
Adverse Events
Time frame: 1 year postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Abbas Khani-Hanjani, MD principal investigator
University of Alberta
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vancomycin and No Vancomycin in people with INFECTION, run by University of Alberta.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Sternal Wound Infections (time frame: 3 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2022.