drugset / Trial / NCT03308253

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

NCT03308253

Phase 4 Unknown 60 enrolled McMaster University
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2018-07-16
Primary completion
2019-06
Completion
2019-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Tobramycin Small molecule 120 mg
Subject Vancomycin Other / unclassified 0.5 g

Indications

No indication recorded.