Topical Vancomycin Over Sternal Edge in Cardiac Surgery

NCT04500275 | Completed Phase 4

• 1 other identifier: A-BR-109-013
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-blind 1:1 randomized controlled trial based on the hypothesis that topical application of vancomycin paste over sternum edge is safe and can reduce sternal wound infection after elective cardiac surgery. Vancomycin paste will be prepared using 2.5 g of vancomycin mixed with 2 ml normal saline. Vancomycin paste as control or 2 ml normal saline as placebo will be spread on sternal edge immediately after sternotomy and before sternal closure. The safety of Vancomycin paste over sternum edge will be assessed according to postoperative serum Vancomycin exposure and potential side effects such as renal toxicity or bacterial resistance. Effect of topical Vancomycin on incidence of postoperative sternal wound infection will be assessed on postoperative 7, 30, and 90 days.

Conditions

Sternal Wound Infection

Outcome Measures

Primary Outcomes (3)

• Sternal wound infection condition on postoperative day 7

  Sternal wound condition evaluate by study nursing practitioner, according to the definition of sternal wound infection based on the Centers for Disease Control and Prevention. 1. Depths 1 and 2 limited to the subcuticular and subcutaneous layers with no involvement of the sternum are defined as a superficial sternal infection (SSI). 2. Depths 3 and 4, which involved the sternal bone or wires and collections beneath the sternum, are defined as deep sternal infection (DSI). 3. A wound was considered infected only if a positive culture was obtained. The sternal wound condition will be coded as "non-infection", "SSI", "DSI"

  postoperative day 7

• Sternal wound infection condition on postoperative day 30

  Sternal wound condition evaluate by study nursing practitioner, according to the definition of sternal wound infection based on the Centers for Disease Control and Prevention. 1. Depths 1 and 2 limited to the subcuticular and subcutaneous layers with no involvement of the sternum are defined as a superficial sternal infection (SSI). 2. Depths 3 and 4, which involved the sternal bone or wires and collections beneath the sternum, are defined as deep sternal infection (DSI). 3. A wound was considered infected only if a positive culture was obtained. The sternal wound condition will be coded as "non-infection", "SSI", "DSI"

  postoperative day 30

• Sternal wound infection condition on postoperative day 90

  Sternal wound condition evaluate by study nursing practitioner, according to the definition of sternal wound infection based on the Centers for Disease Control and Prevention. 1. Depths 1 and 2 limited to the subcuticular and subcutaneous layers with no involvement of the sternum are defined as a superficial sternal infection (SSI). 2. Depths 3 and 4, which involved the sternal bone or wires and collections beneath the sternum, are defined as deep sternal infection (DSI). 3. A wound was considered infected only if a positive culture was obtained. The sternal wound condition will be coded as "non-infection", "SSI", "DSI"

  postoperative day 90

Secondary Outcomes (3)

• Serum Vancomycin exposure on postoperative day 0

  postoperative day 0

• Serum Vancomycin exposure on postoperative day 3

  postoperative day 3

• Serum Vancomycin exposure on postoperative day 7

  postoperative day 7

Study Arms (2)

Vancomycin group

EXPERIMENTAL

i. Timing of application: the Vancomycin (China Chemical \& Pharmaceutical Co., Ltd., CCPC, Taiwan R.O.C.) paste will be spread on sternal edge immediately after sternotomy and before sternal closure. ii. Regimen: The Vancomycin paste will be prepared using 2.5 g of Vancomycin powder mixed with 2 ml normal saline for each time. A total of 5 g of Vancomycin powder will be applied during the cardiac surgery.

Drug: Vancomycin Hydrochloride

Placebo group

PLACEBO COMPARATOR

2 ml normal saline will be spread on sternal edge immediately after sternotomy and before sternal closure.

Other: Normal Saline

Interventions

Vancomycin Hydrochloride DRUG

Vancomycin will be spread on sternal edge immediately after sternotomy and before sternal closure

Also known as: vancomycin® (China Chemical & Pharmaceutical Co., Ltd. (CCPC / Taiwan))

Vancomycin group

Normal Saline OTHER

2 ml normal saline will be spread on sternal edge immediately after sternotomy and before sternal closure

Also known as: Isotonic Sodium chloride 0.9% 20ml/amp (Sintong Taiwan Biotech Company, Limited.)

Placebo group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients admitted for elective cardiac surgery via first-time full sternotomy, such as coronary artery disease, valvular heart disease, adult congenital heart disease, aortic aneurysm.

You may not qualify if:

• redo sternotomy surgery
• minimal invasive or non-full-sternotomy cardiac surgery
• emergent surgery with preoperative shock or cardiopulmonary resuscitation
• heart transplant or ventricular assist device surgery
• patients who have any preoperative mechanical support including IABP, ECMO, or ventricular assist device
• evidence of Vancomycin allergy
• preexisting infection requiring preoperative regular antibiotics
• perioperative immunosuppressive requirement
• Patients with known cephalosporin or beta-lactam allergy who requires Vancomycin plus Gentamicin for intravenous prophylaxis will also be excluded because the intravenous Vancomycin will affect the further measurement of serum Vancomycin level after topical application

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 台南市, 704, Taiwan

Location

Related Publications (6)

• Lazar HL, Ketchedjian A, Haime M, Karlson K, Cabral H. Topical vancomycin in combination with perioperative antibiotics and tight glycemic control helps to eliminate sternal wound infections. J Thorac Cardiovasc Surg. 2014 Sep;148(3):1035-8; 1038-40. doi: 10.1016/j.jtcvs.2014.06.045. Epub 2014 Jul 2.

  PMID: 25129595 BACKGROUND

• Lazar HL, Barlam T, Cabral H. The effect of topical vancomycin applied to sternotomy incisions on postoperative serum vancomycin levels. J Card Surg. 2011 Sep;26(5):461-5. doi: 10.1111/j.1540-8191.2011.01300.x.

  PMID: 21951032 BACKGROUND

• Lander HL, Ejiofor JI, McGurk S, Tsuyoshi K, Shekar P, Body SC. Vancomycin Paste Does Not Reduce the Incidence of Deep Sternal Wound Infection After Cardiac Operations. Ann Thorac Surg. 2017 Feb;103(2):497-503. doi: 10.1016/j.athoracsur.2016.10.020. Epub 2016 Dec 24.

  PMID: 28027730 BACKGROUND

• Vander Salm TJ, Okike ON, Pasque MK, Pezzella AT, Lew R, Traina V, Mathieu R. Reduction of sternal infection by application of topical vancomycin. J Thorac Cardiovasc Surg. 1989 Oct;98(4):618-22.

  PMID: 2796369 BACKGROUND

• Lazar HL, Salm TV, Engelman R, Orgill D, Gordon S. Prevention and management of sternal wound infections. J Thorac Cardiovasc Surg. 2016 Oct;152(4):962-72. doi: 10.1016/j.jtcvs.2016.01.060. Epub 2016 Aug 8. No abstract available.

  PMID: 27555340 BACKGROUND

• Hamman BL, Stout LY, Theologes TT, Sass DM, da Graca B, Filardo G. Relation between topical application of platelet-rich plasma and vancomycin and severe deep sternal wound infections after a first median sternotomy. Am J Cardiol. 2014 Apr 15;113(8):1415-9. doi: 10.1016/j.amjcard.2013.12.046. Epub 2014 Jan 31.

  PMID: 24576548 BACKGROUND

MeSH Terms

Interventions

Vancomycin; Long-Term Synaptic Depression; Saline Solution; Sodium Chloride; Adenosine Monophosphate

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• MENG-TA TSAI, MD

  National Cheng Kung University Hospital, Tainan, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Cardiovascular Surgery, Department of Surgery

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: August 5, 2020
• Study Start: July 1, 2020
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)