Recruiting

Calcium Sulfate Beads

Sponsor:

McMaster University

Code:

NCT03308253

Conditions

Surgical Site Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stimulan Rapid Cure

Vancomycin

Tobramycin

Standard of Care

Study Details

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 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

Study ID

NCT03308253

Start date

Jul 16, 2018

Status verified date

Jul, 2018

Completion date

Jul, 2019

Anticipated

Primary completion date

Jun, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Standard of Care

Patients will receive the standard of care for vascular procedures as it is provided at Hamilton General Hospital

experimental: Antibiotic Impregnated Beads

Patients will have their wound packed with calcium sulfate beads prior to closing. The beads will be infused with the antibiotics vancomycin and tobramycin.

Interventions

Stimulan Rapid Cure

Calcium sulfate dissolvable beads

Vancomycin

0.5 g Vancomycin per patient

Tobramycin

120 mg tobramycin per patient

Standard of Care

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

Primary outcome measure

  • Surgical Site Infection [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Steven Phillips, MSc

905-521-2100phills3@mcmaster.ca

Locations

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Steven Phillips, MSc

905-521-2100phills3@mcmaster.ca

Principal Investigator:

Michael C Stacey

More Information

Sponsor

McMaster University

Last update posted

Jul 19, 2018

Last verified

Jul, 2018

Keywords

  • Vascular Surgery
  • Surgical Site Infection
  • Prophylactic Antibiotics
  • Implantable Beads

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2018-07-19.