Study for Antibiotic Impregnated Calcium Sulfate Beads as Prophylaxis for Surgical Site Infection

• Status: Unknown status
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

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 to 5-10%. Groin incisions are an additional risk factor for surgical site infections, with rates of wound infection being quoted from 10-15%, and even as high as 30% in high risk patients. The use of implantable calcium sulfate beads mixed with antibiotics may help to lower the rate of infection in these high risk patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Calcium, Dietary; Tobramycin; Vancomycin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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