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Topical Gentamicin and Vancomycin for Vascular Surgical Site Infection Prophylaxis

NCT04238923 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2020-01-30

No results posted yet for this study

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.

Conditions

  • Vascular Diseases
  • Peripheral Vascular Disease
  • Surgical Site Infection
  • Bypass Complication

Interventions

DRUG

Topical vancomycin paste (1g vancomycin powder + 4mL sterile saline) and Collatamp G gentamicin-eluting sponge (Azralez Pharmaceuticals; 2.0mg gentamicin sulphate/cm2 to cover wound)

Topical vancomycin paste and gentamicin-eluting collagen sponge will be applied directly to the deep layers of the wound following reconstruction, prior to closure.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Luc Dubois, MD, MSc · London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2021-05-01
Completion
2021-07-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04238923 on ClinicalTrials.gov