Wound ComplicationPhase 1/2NCT06651268
Effectiveness of Topical Vancomycin in Reducing Sternal Wound Infections Post-Cardiac Surgery
A Phase 1/2 study testing while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T in people with Wound Complication and Cardiac Surgery, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
Title: The Role of Vancomycin Powder in Reducing Sternal Wound Infections Following Cardiac Surgery: A Randomized Controlled Trial Introduction: Sternal wound infections (SWIs) are significant complications in cardiac surgery, leading to serious issues like mediastinitis, prolonged hospital stays, and higher… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Wound Complication, Cardiac Surgery
- What is being tested?
- while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2024to 1 Oct 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- .Patients aged between 21 and 80 years were included in the study.
- Both male and female participants were eligible.
- Patients undergoing various adult cardiac surgical procedures, including coronary artery bypass grafting (CABG), atrial septal defect (ASD) repair, ventricular septal defect (VSD) repair, and valve replacement, were considered for inclusion.
Who cannot join
- Patients who did not provide informed consent were excluded from the study.
- Individuals with a known sensitivity to vancomycin were not eligible.
- Pediatric patients were excluded.
- Patients undergoing redo surgeries were also excluded from participation
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Cardiac Surgery
Karachi, Sindh, 74201
Qaisar Aziz Dr, FCPS, +923362405480, qaiserazizdr@hotmail.com
About this study
Official title: Local Application of Vancomycin (powder) Before Surgical Closure Helps to Reduce Sternal Wound Infection After Cardiac Surgery Procedures.
Title: The Role of Vancomycin Powder in Reducing Sternal Wound Infections Following Cardiac Surgery: A Randomized Controlled Trial
Introduction:
Read more
Sternal wound infections (SWIs) are significant complications in cardiac surgery, leading to serious issues like mediastinitis, prolonged hospital stays, and higher healthcare costs. This study explores the potential of topical vancomycin powder to reduce SWIs when added to the standard use of systemic antibiotics.
Objectives:
To assess the effectiveness of vancomycin powder in preventing SWIs post-cardiac surgery.
To determine its impact on postoperative hospital stays.
Study Design and Methodology:
A randomized controlled trial will be conducted at Liaquat National Hospital, Karachi, with 24 patients (12 in each group).
Group A will receive standard wound closure, while Group B will receive vancomycin powder applied to the sternal wound.
Postoperative wound assessments will be conducted at 48 hours, 7 days, and 1 month.
Ethical Considerations:
Ethical approval will be obtained, and informed consent will be sought from all participants
Read the detailed description
The sternotomy approach is widely used in cardiac surgeries, making sternal wound infections a significant concern. These infections can lead to serious complications, including sepsis, reoperation, and increased healthcare costs. Systemic antibiotic prophylaxis is a common practice, but local antibiotic application at the surgical site could further reduce the risk of infection. Vancomycin, due to its effectiveness against gram-positive bacteria, is an ideal candidate for local application. Previous studies in orthopedic surgeries have demonstrated reduced infection rates with vancomycin powder, but its efficacy in cardiac surgery has not been thoroughly explored. This study aims to investigate whether local application of vancomycin powder reduces the incidence of sternal wound infections after cardiac surgery compared to standard care. Additionally, it will evaluate secondary outcomes such as hospital stay duration, postoperative morbidity, and wound-related complications, including dehiscence and the need for reoperation.
The study will be a randomized controlled trial conducted at Liaquat National Hospital, Karachi, Pakistan. A total of 24 patients undergoing cardiac surgery will be randomly allocated to either a control group (standard closure technique) or an intervention group (1 gram of vancomycin powder applied locally before sternal closure). Both groups will receive systemic antibiotic prophylaxis as part of routine care.
This study aims to provide evidence on the efficacy of local vancomycin powder application in reducing sternal wound infections after cardiac surgery. If successful, it could offer a simple, cost-effective intervention to improve postoperative outcomes in cardiac surgery patients. Further research may be needed to validate the findings and support its widespread implementation.
- Conditions
- Wound Complication, Cardiac Surgery
- Being tested
- while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. TDrug
while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T
| Study group | Role | What they receive |
|---|---|---|
| while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T | Experimental | Not described Receives: Drug: while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T |
| : Group A (control, n=12) received standard closure techniques without vancomycin powder | Other | Group A (control, n=12) received standard closure techniques without vancomycin powder Receives: Drug: while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sternal wound infections (SWIs) following cardiac surgery
Incidence of sternal wound infections (SWIs) following cardiac surgery in patients who receive vancomycin powder application compared to those who do not. The infections would be diagnosed based on clinical signs such as redness, pain, swelling, and purulent discharge at the wound site.
Measured: he patients will be evaluated at three key time points: 48 hours post-surgery 7 days post-surgery 1 month post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound ComplicationStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qaiser Aziz, Liaquat National Hospital & Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651268
- Sponsor's protocol ID
- LNH-2024
- Status last verified
- Jan 2024
- First submitted
- 18 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to privacy issue
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Application of Vancomycin (powder) Before Surgical Closure Helps to Reduce Sternal Wound Infection After Cardiac Surgery Procedures.
- ClinicalTrials.gov ID
- NCT06651268
- Acronym / sponsor ID
- LNH-2024
- Conditions
- Wound Complication, Cardiac Surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 21 Oct 2024 (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.
Title: The Role of Vancomycin Powder in Reducing Sternal Wound Infections Following Cardiac Surgery: A Randomized Controlled Trial
Introduction:
Sternal wound infections (SWIs) are significant complications in cardiac surgery, leading to serious issues like mediastinitis, prolonged hospital stays, and higher healthcare costs. This study explores the potential of topical vancomycin powder to reduce SWIs when added to the standard use of systemic antibiotics.
Objectives:
To assess the effectiveness of vancomycin powder in preventing SWIs post-cardiac surgery.
To determine its impact on postoperative hospital stays.
Study Design and Methodology:
A randomized controlled trial will be conducted at Liaquat National Hospital, Karachi, with 24 patients (12 in each group).
Group A will receive standard wound closure, while Group B will receive vancomycin powder applied to the sternal wound.
Postoperative wound assessments will be conducted at 48 hours, 7 days, and 1 month.
Ethical Considerations:
Ethical approval will be obtained, and informed consent will be sought from all participants
Detailed description
The sternotomy approach is widely used in cardiac surgeries, making sternal wound infections a significant concern. These infections can lead to serious complications, including sepsis, reoperation, and increased healthcare costs. Systemic antibiotic prophylaxis is a common practice, but local antibiotic application at the surgical site could further reduce the risk of infection. Vancomycin, due to its effectiveness against gram-positive bacteria, is an ideal candidate for local application. Previous studies in orthopedic surgeries have demonstrated reduced infection rates with vancomycin powder, but its efficacy in cardiac surgery has not been thoroughly explored. This study aims to investigate whether local application of vancomycin powder reduces the incidence of sternal wound infections after cardiac surgery compared to standard care. Additionally, it will evaluate secondary outcomes such as hospital stay duration, postoperative morbidity, and wound-related complications, including dehiscence and the need for reoperation.
The study will be a randomized controlled trial conducted at Liaquat National Hospital, Karachi, Pakistan. A total of 24 patients undergoing cardiac surgery will be randomly allocated to either a control group (standard closure technique) or an intervention group (1 gram of vancomycin powder applied locally before sternal closure). Both groups will receive systemic antibiotic prophylaxis as part of routine care.
This study aims to provide evidence on the efficacy of local vancomycin powder application in reducing sternal wound infections after cardiac surgery. If successful, it could offer a simple, cost-effective intervention to improve postoperative outcomes in cardiac surgery patients. Further research may be needed to validate the findings and support its widespread implementation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T | Experimental | Drug: while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T |
| : Group A (control, n=12) received standard closure techniques without vancomycin powder | Other | Drug: while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. TGroup A (control, n=12) received standard closure techniques without vancomycin powder |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- .Patients aged between 21 and 80 years were included in the study.
- Both male and female participants were eligible.
- Patients undergoing various adult cardiac surgical procedures, including coronary artery bypass grafting (CABG), atrial septal defect (ASD) repair, ventricular septal defect (VSD) repair, and valve replacement, were considered for inclusion.
Key exclusion criteria (4 listed)
- Patients who did not provide informed consent were excluded from the study.
- Individuals with a known sensitivity to vancomycin were not eligible.
- Pediatric patients were excluded.
- Patients undergoing redo surgeries were also excluded from participation
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 |
|---|---|---|
| while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. Twhile Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T | Drug | : Group A (control, n=12) received standard closure techniques without vancomycin powder, while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T |
Primary outcome
Incidence of sternal wound infections (SWIs) following cardiac surgery
Time frame: he patients will be evaluated at three key time points: 48 hours post-surgery 7 days post-surgery 1 month post-surgery
Incidence of sternal wound infections (SWIs) following cardiac surgery in patients who receive vancomycin powder application compared to those who do not. The infections would be diagnosed based on clinical signs such as redness, pain, swelling, and purulent discharge at the wound site.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: No. Due to privacy issue
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T in people with Wound Complication and Cardiac Surgery, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
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 4 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: status not confirmed, as of the sponsor's last update on 28 Oct 2024. 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 Pakistan. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qaiser Aziz qaiserazizdr@hotmail.com, FCPS (+923362405480, qaiserazizdr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of sternal wound infections (SWIs) following cardiac surgery (time frame: he patients will be evaluated at three key time points: 48 hours post-surgery 7 days post-surgery 1 month post-surgery). 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 28 Oct 2024.