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

NCT03308253 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-07-19

No results posted yet for this study

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.

Conditions

  • Surgical Site Infection

Interventions

DEVICE

Stimulan Rapid Cure

Calcium sulfate dissolvable beads

DRUG

Vancomycin

0.5 g Vancomycin per patient

DRUG

Tobramycin

120 mg tobramycin per patient

OTHER

Standard of Care

Standard of care provided at Hamilton General Hospital consisting of dressings for the wound.

Sponsors & Collaborators

Principal Investigators

  • Michael C Stacey, DS · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2019-06-30
Completion
2019-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03308253 on ClinicalTrials.gov