Comparing Antibiotic Cement Bead Pouch with Negative Pressure Wound Therapy for open tíbia fracture
Official title: Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
A Randomized Controlled Trial Comparing Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy for the Management of Severe Open Tibia Fracture Wounds
- Phase 3
- 2 groups
- Sites in New Westminster, Vancouver and 3 more cities
- Recruiting
Interventions
- Medication
Antibiotic Cement Bead Pouch
The antibiotic bead pouch provides an antibiotic delivery mechanism. It is made by combining polymethyl methacrylate (PMMA) cement with generic forms of vancomycin and tobramycin powder.
- Medical device
Negative Pressure Wound Therapy
Standard application of negative pressure wound therapy
Canadian Sites (5)
5 of 5 recruiting
- Recruiting
Royal Columbian Hospital
New Westminster, British Columbia
- Recruiting
University of British Columbia
Vancouver, British Columbia
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario
- Recruiting
London Health Sciences Centre
London, Ontario
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
Eligibility Criteria
See who this study is looking for31 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Medical contraindication to antibiotic beads, including previously known allergies or sensitivities to vancomycin and/or tobramycin.
- +Patients 18 years of age or older.
- +Severe open tibia fracture requiring more than one irrigation and debridement procedure to treat the open fracture.
- +Planned internal or external fixation for definitive fracture management.
- +Formal surgical debridement within 72 hours of their injury.
- +Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
- +Informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → obtained.
- +The exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are:
- +Due to the severity of injury, the treating surgeon does not believe limb salvage \>6 months is likely to be successful based on the emergency department or initial intraoperative assessment (prior to enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → and randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →).
- +Medical or injury contraindication to NPWT. Injury contraindications could include situations in which the NPWT could not be placed over a vascular graft or exposed neurovascular structure.
- +Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic (as applicable).
- +Incarceration.
- +Currently enrolled in a study that does not permit co-enrollment.
- +Unable to obtain informed consent due to language barriers.
- +Anticipated problems, in the judgment of research personnel, with maintaining follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → with the patient.
- +Prior enrollment in the trial.
- +Other reason to exclude the patient, as approved by the Methods Center.
- +Women of child-bearing potential who are pregnant or intending to become pregnant within the next 6 months.
- +Chronic or acute infection at or near the fracture siteTrial siteA hospital or clinic where a study is actually run.Read more → at the time of initial fracture surgery.
Exclusion
- −Medical contraindication to antibiotic beads, including previously known allergies or sensitivities to vancomycin and/or tobramycin.
- −Due to the severity of injury, the treating surgeon does not believe limb salvage \>6 months is likely to be successful based on the emergency department or initial intraoperative assessment (prior to enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → and randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →).
- −Medical or injury contraindication to NPWT. Injury contraindications could include situations in which the NPWT could not be placed over a vascular graft or exposed neurovascular structure.
- −Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic (as applicable).
- −Incarceration.
- −Currently enrolled in a study that does not permit co-enrollment.
- −Unable to obtain informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → due to language barriers.
- −Anticipated problems, in the judgment of research personnel, with maintaining follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → with the patient.
- −Prior enrollment in the trial.
- −Other reason to exclude the patient, as approved by the Methods Center.
- −Women of child-bearing potential who are pregnant or intending to become pregnant within the next 6 months.
- −Chronic or acute infection at or near the fracture siteTrial siteA hospital or clinic where a study is actually run.Read more → at the time of initial fracture surgery.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Antibiotic Cement Bead Pouch.
Registry label: A: Antibiotic Cement Bead Pouch
Group B, the comparison group, receives Negative Pressure Wound Therapy.
Registry label: B: Negative Pressure Wound Therapy (NPWT)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 312 people.
The study is currently expected to finish around October 2027.
The main measurement is taken over: 6 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Clinical status — measured over 6 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05615844 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Antibiotic Cement Bead PouchDrug
The antibiotic bead pouch provides an antibiotic delivery mechanism. It is made by combining polymethyl methacrylate (PMMA) cement with generic forms of vancomycin and tobramycin powder.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Negative Pressure Wound TherapyDevice
Standard application of negative pressure wound therapy
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 6 months.
The study as a whole is currently expected to finish around 2027-10-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 312 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 5 locations, including: New Westminster, British Columbia, Canada; Vancouver, British Columbia, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada; Ottawa, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The Beads vs Vac trial is a multi-centre randomized controlled trial of 312 participants with a severe open tibia fracture requiring multiple irrigation and debridement surgeries. Eligible participants will be randomized to receive either an antibiotic bead pouch or negative pressure wound therapy (NPWT) for their temporary open fracture wound management. Outcomes will be assessed at 6 weeks, 3 months, and 6 months post-surgery. The primary outcome will be a composite outcome to evaluate clinical status six months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) injury-related amputation of the lower extremity, 3) unplanned reoperation to manage wound complications, infection, or delayed fracture healing, and 4) clinical fracture healing as assessed using the Functional IndeX for Trauma (FIX-IT) instrument. The secondary outcomes will independently assess the four components of the primary outcome. This is a Phase III trial.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.