Home » Trials » SLCTR/2026/024
Effect of Vancomycin applied over transected sternal edges on the rate of wound infections in patients undergoing Coronary Artery Bypass Grafting at National Hospital Kandy, Sri Lanka: A randomized controlled trial
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SLCTR Registration Number
SLCTR/2026/024
Date of Registration
The date of last modification
Sep 15, 2026
Scientific Title of Trial
Effect of Vancomycin applied over transected sternal edges on the rate of wound infections in patients undergoing Coronary Artery Bypass Grafting at National Hospital Kandy, Sri Lanka: A randomized controlled trial
Public Title of Trial
Effect of Vancomycin applied over transected sternal edges on the rate of wound infections compared to standard of care in patients undergoing Coronary Artery Bypass Grafting at National Hospital Kandy, Sri Lanka: A randomized controlled trial
Disease or Health Condition(s) Studied
Ischemic heart disease, Coronary bypass surgery
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1343-5284
Any other number(s) assigned to the trial and issuing authority
2026/EC/11
What is the research question being addressed?
Does the local application of vancomycin over the transected sternal edges during coronary artery bypass grafting reduce the rate of postoperative surgical site infections compared with standard care among patients treated at National Hospital Kandy, Sri Lanka?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Phase 3
Intervention(s) planned
Study setting: Cardiothoracic Surgical Unit, National Hospital Kandy, Sri Lanka.
Randomization: Individual participants will be randomized in a 1:1 ratio using block randomization with variable block sizes of 4, 6 and 8. The randomization sequence will be generated before study commencement using the Sealed Envelope blocked randomization system. Unit of randomization: Individual participant. Allocation concealment: The randomization codes will be kept securely under lock and key by the ward master/sister in the preoperative ward. The ward master/sister will communicate the allocation to the lead operating-theatre nurse by telephone immediately before sternal closure. The lead nurse will inform the trial team of the allocation.
Intervention: Vancomycin 2 g, prepared as a paste and applied topically over the transected sternal edges once, immediately before sternal closure, after the previously applied bone wax has been scraped off. The application is performed following the coronary artery bypass grafting operation by the consultant cardiothoracic surgeon or a trained medical officer. Control: Standard care. After the previously applied bone wax is scraped off, the sternum is closed according to routine unit practice without application of vancomycin. No study vancomycin is administered to the control group.
Standard care: Both groups undergo CABG and routine perioperative/postoperative care according to the National Hospital Kandy cardiothoracic unit standard practice, including the usual antibiotic cover. Blinding: Participants and outcome assessors will be blinded to allocation. The surgical team administering the intervention cannot be blinded because allocation is required immediately before sternal closure. Outcome assessments will be performed by medical officers/consultants who are blinded to the intervention
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Incidence of postoperative sternal surgical site/wound infection, assessed by wound inspection for discharge and pain, measurement of temperature for fever with or without FBC, CRP as indicated |
[ postoperative 5 days , 1 month and 3 months intervals ] |
Secondary outcome(s)
|
1.
Postoperative hospital length of stay, measured in days from surgery/admission until hospital discharge. |
[ At the time of discharge ] |
|
2.
Dose and duration of the usual perioperative antibiotic cover received by each participant, recorded from the treatment/medication records |
[ Time of discharge, 3 weeks and 3 months ] |
|
3.
Use of additional antibiotics on top of the usual antibiotic cover for patients undergoing coronary artery bypass grafting and National hospital Kandy – Number of days |
[ Time of discharge, 3 weeks and 3 months ] |
|
4.
Clinical findings related to sternal wound healing an infections during scheduled follow-up assessments at postoperative day 5 |
[ Postoperative day 5 ] |
Target number/sample size
60, 30 in each arm
Countries of recruitment
Sri Lanka
Anticipated start date
2026-09-25
Anticipated end date
2028-02-28
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
No
Regulatory approvals
Ethical review committee, Faculty of Medicine, University of Peradeniya.
Status
Approved
Date of Approval
2026-06-21
Approval number
2026/EC/11
Details of Ethics Review Committee
| Name: | Ethical review committee, Faculty of Medicine, University of Peradeniya. |
| Institutional Address: | Faculty of Medicine, University of Peradeniya. |
| Telephone: | 081-2389106 |
| Email: | chairperson.erc@med.pdn.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr. Muditha Lansakara
Consultant Cardiothoracic Surgeon
Cardiothoracic Surgery Unit,
National hospital,
Kandy,
Sri Lanka
071-0316907
071- 8480625
mudithalansa@yahoo.co.in
Contact Person for Public Queries
Dr. Muditha Lansakara
Consultant Cardiothoracic Surgeon
Cardiothoracic Surgery Unit,
National hospital,
Kandy,
Sri Lanka
071-0316907
071- 8480625
mudithalansa@yahoo.co.in
Primary study sponsor/organization
Cardiothoracic Surgical Unit/Department, National Hospital Kandy, Sri Lanka
National hospital,
Kandy,
Sri Lanka
071-0316907
https://nhkandy.org/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
On request with the approval of study team and the hospital administration
Study protocol available
Yes
Protocol version and date
Version II, 06.05.2026
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
