Surgical Site InfectionPhase 4NCT03308253
Study for Antibiotic Impregnated Calcium Sulfate Beads as Prophylaxis for Surgical Site Infection
A Phase 4 study testing Stimulan Rapid Cure, Vancomycin and Tobramycin in people with Surgical Site Infection, run by McMaster University at 1 site in Canada.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Stimulan Rapid Cure, Vancomycin and Tobramycin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jul 2018to Jul 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Steven Phillips, MSc, 905-521-2100 ext. 44167, phills3@mcmaster.ca
Michael C Stacey
About this study
Official title: Pilot Study for Antibiotic Impregnated Calcium Sulfate Beads as Prophylaxis for Surgical Site Infection in Vascular Surgery Patients
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.
Read the detailed description
The initial pilot will consist of 30 patients per arm and will provide estimates of effect size, event rates, and recruitment rates. It will mirror the final study in terms of methodology. This will occur at the Hamilton General Hospital (Hamilton, ON. Canada)
Patients will be randomized to either the exposure group or control group by the study coordinator. Patients will be block randomized among surgeons (6), so that each surgeon has an equal number of patients in the control and exposure arms. Randomization will occur once an operative date has been booked for a patient. The arm they are assigned to will be how the patient is treated, regardless of if they are cancelled and re-booked. Should patients be done as an emergency procedure, prior to their index procedure (when the beads would be implanted), they will be excluded from the study. As no intervention has occurred at this point, there will be no informative loss to follow-up or censoring and therefore this will not impact validity of the design. We are unable to provide beads for emergency procedures, as the research pharmacy is not open.
The research coordinator will inform the research pharmacy to produce calcium sulfate beads impregnated with Vancomycin (1g) and Tobramycin (240mg) for the exposure arm. The control arm will receive standard care. The only difference between standard care and the treatment arm is the use of the antibiotic calcium sulfate beads. Beads will be delivered in a sterile manner to the OR. For each patient half of a standard 10cc kit will be delivered (5cc of Stimulan Calcium Sulfate). As the beads are being applied only to a groin incision(s) this will provide an adequate volume of beads. It will also prevent insertion of excess beads.
Surgeons will insert the beads loosely within the soft tissue of groin incisions, so as not to distort the normal anatomy. This technique will be discussed with all surgeons prior to pilot initiation as a group. This will aim to standardize the method among involved surgeons. At the end of the study we will complete a focus group with surgeons to discuss their experience using the beads to better inform the protocol for the final RCT. Patients are randomized as a unit and therefore, if there are bilateral groin incisions, both will be treated as per their randomization.
Patients will be blinded to which treatment they receive. The beads are believed to be non-detectable to the patient. Only by means of wound dehiscence would a patient be expected to determine their treatment group. For practical reasons the surgeon cannot be blinded to treatment. Nurse assessors and study authors conducting review of patient records will be blinded to patient treatment.
Patients will be recruited from all patients consented for an included procedure at HGH. A study coordinator or a resident will obtain consent. The patient's primary physician will not be involved in the consent process.
- Conditions
- Surgical Site Infection
- Being tested
- Stimulan Rapid Cure, Vancomycin, Tobramycin, Standard of Care
- Keywords
- Vascular Surgery, Surgical Site Infection, Prophylactic Antibiotics, Implantable Beads
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulan Rapid CureDevice
Calcium sulfate dissolvable beads
VancomycinDrug
0.5 g Vancomycin per patient
TobramycinDrug
120 mg tobramycin per patient
Standard of CareOther
Standard of care provided at Hamilton General Hospital consisting of dressings for the wound.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Patients will receive the standard of care for vascular procedures as it is provided at Hamilton General Hospital Receives: 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. Receives: Device: Stimulan Rapid Cure; Drug: Vancomycin; Drug: Tobramycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (3)
Wound Complication Rate
Wound complications will be defined as: wound dehiscence, skin edge necrosis, hematoma, seroma, increased wound exudate, graft exposure. These will be measured with a standardized form, by the blinded nurse assessor, at each follow-up appointment. They will additionally be assessed by the author reviewing patient records at thirty days. If imaging is required for diagnosis of hematoma or seroma, the result will be collected from the imaging records, and treated as consistent with the conclusions of the formal imaging report.
Measured: 30 day
Surgical Graft Infection Rate
Graft infection is defined as; diagnosis by surgeon or surgical designate requiring re-operation or prolonged course of antibiotic therapy. An author blinded to patient treatment will review the records of the patient including patient charts, antibiotic prescriptions, home care and ID referrals and record the information in a standardized form for this endpoint.
Measured: 90 day
Bacterial Resistance
In the event of infection requiring laboratory samples, screening for resistant bacteria will be performed. Bacterial cultures will be performed in order to determine the presence of tobramycin or vancomycin resistant strains.
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start16 Jul 2018
- Primary completionJun 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael C Stacey, DS, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308253
- Sponsor's protocol ID
- Antimicrobial Beads
- Status last verified
- Jul 2018
- First submitted
- 3 Oct 2017
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared for this pilot study.
Publications
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.
PubMed 41159585Cristino 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.
PubMed 40260835
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Antibiotic Impregnated Calcium Sulfate Beads as Prophylaxis for Surgical Site Infection in Vascular Surgery Patients
- ClinicalTrials.gov ID
- NCT03308253
- Acronym / sponsor ID
- Antimicrobial Beads
- Conditions
- Surgical Site Infection
- Keywords
- Vascular Surgery, Surgical Site Infection, Prophylactic Antibiotics, Implantable Beads
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 12 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The initial pilot will consist of 30 patients per arm and will provide estimates of effect size, event rates, and recruitment rates. It will mirror the final study in terms of methodology. This will occur at the Hamilton General Hospital (Hamilton, ON. Canada)
Patients will be randomized to either the exposure group or control group by the study coordinator. Patients will be block randomized among surgeons (6), so that each surgeon has an equal number of patients in the control and exposure arms. Randomization will occur once an operative date has been booked for a patient. The arm they are assigned to will be how the patient is treated, regardless of if they are cancelled and re-booked. Should patients be done as an emergency procedure, prior to their index procedure (when the beads would be implanted), they will be excluded from the study. As no intervention has occurred at this point, there will be no informative loss to follow-up or censoring and therefore this will not impact validity of the design. We are unable to provide beads for emergency procedures, as the research pharmacy is not open.
The research coordinator will inform the research pharmacy to produce calcium sulfate beads impregnated with Vancomycin (1g) and Tobramycin (240mg) for the exposure arm. The control arm will receive standard care. The only difference between standard care and the treatment arm is the use of the antibiotic calcium sulfate beads. Beads will be delivered in a sterile manner to the OR. For each patient half of a standard 10cc kit will be delivered (5cc of Stimulan Calcium Sulfate). As the beads are being applied only to a groin incision(s) this will provide an adequate volume of beads. It will also prevent insertion of excess beads.
Surgeons will insert the beads loosely within the soft tissue of groin incisions, so as not to distort the normal anatomy. This technique will be discussed with all surgeons prior to pilot initiation as a group. This will aim to standardize the method among involved surgeons. At the end of the study we will complete a focus group with surgeons to discuss their experience using the beads to better inform the protocol for the final RCT. Patients are randomized as a unit and therefore, if there are bilateral groin incisions, both will be treated as per their randomization.
Patients will be blinded to which treatment they receive. The beads are believed to be non-detectable to the patient. Only by means of wound dehiscence would a patient be expected to determine their treatment group. For practical reasons the surgeon cannot be blinded to treatment. Nurse assessors and study authors conducting review of patient records will be blinded to patient treatment.
Patients will be recruited from all patients consented for an included procedure at HGH. A study coordinator or a resident will obtain consent. The patient's primary physician will not be involved in the consent process.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Other: Standard of CarePatients will receive the standard of care for vascular procedures as it is provided at Hamilton General Hospital |
| Antibiotic Impregnated Beads | Experimental | Device: Stimulan Rapid Cure, Drug: Vancomycin, Drug: TobramycinPatients will have their wound packed with calcium sulfate beads prior to closing. The beads will be infused with the antibiotics vancomycin and tobramycin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimulan Rapid CureCalcium sulfate dissolvable beads | Device | Antibiotic Impregnated Beads |
| Vancomycin0.5 g Vancomycin per patient | Drug | Antibiotic Impregnated Beads |
| Tobramycin120 mg tobramycin per patient | Drug | Antibiotic Impregnated Beads |
| Standard of CareStandard of care provided at Hamilton General Hospital consisting of dressings for the wound. | Other | Standard of Care |
Primary outcome
Surgical Site Infection
Time frame: 30 days
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.
3 secondary outcomes
Wound Complication Rate
Time frame: 30 day
Surgical Graft Infection Rate
Time frame: 90 day
Bacterial Resistance
Time frame: 30 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Derived from this study: PubMed 41159585Correia 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.
- Derived from this study: PubMed 40260835Cristino 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.
- Individual participant dataSharing planned: No. Individual patient data will not be shared for this pilot study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael C Stacey, DS principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stimulan Rapid Cure, Vancomycin and Tobramycin in people with Surgical Site Infection, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven Phillips, MSc (905-521-2100 ext. 44167, phills3@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308253, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.