Status:
UNKNOWN
Study for Antibiotic Impregnated Calcium Sulfate Beads as Prophylaxis for Surgical Site Infection
Lead Sponsor:
McMaster University
Conditions:
Surgical Site Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The CDC quotes a rate of wound infection of 2-5% for inpatient surgery. Patients undergoing a vascular operation, however, are generally at an increased risk of wound infection with rates often close ...
Detailed Description
The initial pilot will consist of 30 patients per arm and will provide estimates of effect size, event rates, and recruitment rates. It will mirror the final study in terms of methodology. This will o...
Eligibility Criteria
Inclusion
- Men and women aged \> 18
- Undergoing a revascularization procedure involving the femoral artery and requiring either unilateral or bilateral groin incision
- BMI \> 30
- Presence of one of the following: current smoker, diabetes requiring pharmacologic intervention, previous re-vascularization procedure
Exclusion
- Any patient with a current infection or requiring ongoing use of antibiotics
- Any patient who otherwise has an indication requiring the use of antibiotic impregnated material
- Known allergy or sensitivity to tobramycin or vancomycin
- Grade 4 or 5 chronic kidney disease
- Moderate or severe hypercalcemia
- Any woman currently pregnant or planning on becoming pregnant during the course of the study
- Any patient involved in another study that, in the investigators opinion, is believed will interfere with the study
Key Trial Info
Start Date :
July 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03308253
Start Date
July 16 2018
End Date
July 1 2019
Last Update
July 19 2018
Active Locations (1)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2