Topical Gentamicin and Vancomycin for Vascular Surgical Site Infection Prophylaxis

NCT04238923 | Unknown Phase 2 FDA Drug

• 1 other identifier: 115156
• Study Type: interventional
• Target: 356
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of participants with surgical site infection (%)

  Per CDC definition and according to Szilagyi classification

  90 days

Secondary Outcomes (5)

• Length of stay

  Perioperative period

• Number of Emergency Department Visits

  90 days

• Number of participants dying of any cause

  90 days

• Number of participants requiring re-operation

  90 days

• Number of participants requiring major lower limb amputation

  90 days

Study Arms (2)

Topical Gentamicin and Vancomycin

EXPERIMENTAL

Immediately prior to closure of the incision, 1g of vancomycin will be mixed in 4mL of normal saline and applied as a paste directly to the muscle, fascia and subcutaneous tissue. Gentamicin-eluting collagen sponges will be cut to the appropriate size to cover the defect and applied after application of vancomycin. Following closure, the surgical site will be covered with a sterile dressing and left in place for 48hrs.

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)

Control

NO INTERVENTION

The surgical wound is closed in the standard fashion with 3 layer closure with staples for skin. Following closure, the surgical site will be covered with a sterile dressing and left in place for 48hrs.

Interventions

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) DRUG

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

Topical Gentamicin and Vancomycin

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Related Publications (30)

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MeSH Terms

Conditions

Vascular Diseases; Peripheral Vascular Diseases; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luc Dubois, MD, MSc

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominic S LeBlanc, MD

CONTACT

5196858500; dominic.leblanc@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 23, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: July 1, 2021
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share