Topical Gentamicin and Vancomycin for Vascular Surgical Site Infection Prophylaxis

• Status: Not yet recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Many patients who undergo vascular surgery to improve the blood flow to their legs are at risk of developing an infection in the surgical site and are then at risk of serious complications such as hospital readmission, failure of the surgical procedure and lower limb amputation. Surgical site infections may be reduced in high-risk patients by applying two commonly used antibiotics (gentamicin and vancomycin) into the surgical incision at the end of the surgical procedure. This will be compared to the standard of care treatment at London Health Sciences Center.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: Anti-Infective Agents; Anti-Infective Agents, Local; Gentamicins; Vancomycin

Criteria

Inclusion Criteria:

Patients identified as requiring lower extremity bypass for peripheral arterial disease by their consultant surgeon with high-risk features for vascular surgical site infection including,

• BMI >30

• Dialysis dependence

• Redo surgery

• Diabetes mellitus (type 1 or 2)

• Tissue loss (ischemic ulceration or gangrene of the feet)

Exclusion Criteria:

• Patient does not provide informed consent for surgery or study

• Patient received antibiotics for an active infection within 7 days prior to surgery

• Patient has an allergy to gentamicin or vancomycin

• Patient has a pre-existing infection of the surgical site