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

NCT03308253 | Unknown Phase 4 DMC

• 1 other identifier: Antimicrobial Beads
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection

  The primary outcome will be combined, superficial, deep or organ/space infection as defined by the CDC. The CDC definition for surgical site infection is one of the most widely used and is both the NSQUIP and NHSN definition.

  30 days

Secondary Outcomes (3)

• Wound Complication Rate

  30 day

• Surgical Graft Infection Rate

  90 day

• Bacterial Resistance

  30 day

Study Arms (2)

Standard of Care

OTHER

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

Other: Standard of Care

Antibiotic Impregnated Beads

EXPERIMENTAL

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

Device: Stimulan Rapid Cure; Drug: Vancomycin; Drug: Tobramycin

Interventions

Stimulan Rapid Cure DEVICE

Calcium sulfate dissolvable beads

Antibiotic Impregnated Beads

Vancomycin DRUG

0.5 g Vancomycin per patient

Antibiotic Impregnated Beads

Tobramycin DRUG

120 mg tobramycin per patient

Antibiotic Impregnated Beads

Standard of Care OTHER

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

Related Publications (2)

• Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.

  PMID: 41159585 DERIVED

• Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.

  PMID: 40260835 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Vancomycin; Tobramycin; Standard of Care

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michael C Stacey, DS

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Phillips, MSc

CONTACT

905-521-2100; phills3@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 12, 2017
• Study Start: July 16, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)