Open FracturePhase 4PIVOTNCT06504992
Powdered Intrawound Vancomycin in Open Fractures Trial
A Phase 4 study testing Vancomycin 1000 MG in people with Open Fracture and Trauma, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this randomized control trial is to compare the rate of post-operative infection in patients with open fractures in upper or lower extremity long bones randomized to receive intra-operative intrawound topical vancomycin powder on their open fractures in addition to the current best practice of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Fracture, Trauma, Infection, Surgical Site
- What is being tested?
- Vancomycin 1000 MG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2024to 1 Sep 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- 18 years or older at time of surgery
- Patients with an open fracture classified as Gustilo Type I to IIIc in the clavicle, humerus, radius, ulna, metacarpals, upper extremity phalanges (fingers), femur, tibia, fibula and metatarsals and lower extremity phalanges (toes).
- Open fracture treated operatively with plate(s) and screw(s) hardware fixation and intramedullary fixation (IM nail).
- Able to attend standard of care follow up for six months post-operatively
Who cannot join
- Patients with known vancomycin allergy, drug administration reaction, or other sensitivities to vancomycin.
- Patients who have already had definitive fracture fixation before enrollment in the study
- Patients with open fracture already infected at time of enrollment
- Patients with current positive blood cultures (bacteremia) at time of enrollment (current, meaning they have not received treatment and now have negative most-recent blood cultures).
- Patients who have other forms of local antibiotics that are left in place at the end of the definitive fixation surgery (e.g., antibiotic loaded cement or polymethyl methacrylate (PMMA) beads)
- Patients who do not speak English
Show all 9Show fewer
- Patients who are currently pregnant
- Patients who are unable to provide consent and do not have a substitute decision maker able to provide consent
- Patients who will have severe difficulty with follow up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Madison Price, MD contact
About this study
Official title: Powdered Intrawound Vancomycin in Open Fractures: a Randomized Controlled Trial
The purpose of this randomized control trial is to compare the rate of post-operative infection in patients with open fractures in upper or lower extremity long bones randomized to receive intra-operative intrawound topical vancomycin powder on their open fractures in addition to the current best practice of intravenous antibiotics with irrigation and debridement compared to intravenous antibiotics with irrigation and debridement alone during definitive operative fixation of the fracture.
Read the detailed description
Primary Objective:
To evaluate the effect of intra-operative intrawound topical vancomycin powder on open fractures in addition to the current best practice of intravenous antibiotics with irrigation and debridement compared to intravenous antibiotics with irrigation and debridement alone during definitive fixation of the fracture on deep surgical site infection, defined as a post-operative surgical infection requiring return to the operating room for irrigation and debridement with or without hardware removal/revision within the first six months following surgery.
Secondary Objectives:
To evaluate the effect of intra-operative intrawound topical vancomycin powder on superficial surgical site infection, defined as a post-operative infection that required antibiotic treatment but no return to the operating room, readmissions to hospital for post-operative surgical infection (deep or superficial), and hardware failure, defined as hardware loosening, loss of fixation, hardware fracture, or hardware migration, visualized either on imaging or found intra-operatively.
To evaluate differences in microbe characteristics in cultures taken intra-operatively in the take-back irrigation and debridement surgery in patients with deep surgical site infection.
To evaluate if the effect of intra-operative intrawound topical vancomycin powder changes based on fracture and patient characteristics: upper extremity versus lower extremity, Gustilo Classification, patients with documented Methicillin-resistant Staphylococcus aureus (MRSA) colonization, and mechanism of injury.
To evaluate if certain fracture and patient characteristics: upper extremity versus lower extremity, Gustilo Classification, patients with documented Methicillin-resistant Staphylococcus aureus (MRSA) colonization, and by their mechanism of injury increases the risk of infection in both the treatment and control group.
- Conditions
- Open Fracture, Trauma, Infection, Surgical Site, Fractures, Open, Wound Infection, Fractures, Bone
- Being tested
- Vancomycin 1000 MG
- Keywords
- open fracture, vancomycin, infection, trauma, intrawound
- Medical subject headings
- Fractures, Open, Wounds and Injuries, Surgical Wound Infection, Wound Infection, Fractures, Bone, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin 1000 MGDrug
Also called Treatment
Powdered, intrawound vancomycin 1000 mg at the time of definitive surgery for open fracture fixation in addition to the current best practice of intravenous antibiotics with irrigation and debridement
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Powdered, intrawound vancomycin 1000 mg at the time of definitive surgery for open fracture fixation in addition to the current best practice of intravenous antibiotics with irrigation and debridement Receives: Drug: Vancomycin 1000 MG |
| Control | No intervention | Intravenous antibiotics with irrigation and debridement alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep surgical site infection
A post-operative surgical infection requiring return to the operating room for irrigation and debridement with or without hardware removal/revision after the definitive fixation.
Measured: Within six months of definitive surgical orthopedic fixation
Secondary outcomes (7)
Superficial surgical site infection
A post-operative infection that required antibiotic treatment but no return to the operating room
Measured: Within six months of definitive surgical orthopedic fixation
Hardware failure visualized either on imaging or found intra-operatively, until six months post definitive fixation
Hardware loosening, loss of fixation, hardware fracture, or hardware migration visualized either on imaging or found intra-operatively
Measured: Up until six months following definitive fixation
Microbe sensitivity
In patients with deep surgical site infection, the gram stain and sensitivity and resistance to antibiotics of cultures taken intra-operatively in the take-back irrigation and debridement surgery
Measured: Up until six months following definitive fixation
Fracture location
Whether the fracture is in the upper extremity: clavicle, humerus, radius, ulna, metacarpals and phalanges (fingers) versus lower extremity: femur, tibia, fibula, metatarsals, and phalanges (toes).
Measured: At time of initial open fracture
Fracture Gustilo Classification
Open fracture classification from Type I to IIIc that classifies open fractures based on extent of bone, soft tissue and vascular injuries.
Measured: At time of definitive surgical orthopedic fixation.
Mechanism of injury
Mechanism of injury will be categorized as:
- Motor vehicle collision: car occupant, pedestrian, motorcyclist, other ii. Other Vehicle Accident: all-terrain vehicle (ATV), bicycle, snowmobile iii. Fall: from own height (slip/stumble), from height less than or equal to 3 metres, from height greater than 3 metres iv. Laceration v. Striking with blunt object (unintentional) vi. Crush injury vii. Sport related injury viii. Interpersonal violence: stabbing, striking with sharp object (e.g., machete), striking with blunt object, gunshot, other
Measured: At time of initial open fracture
MRSA colonization
Nasal swab for MRSA that is routinely taken for all patients admitted to the study's hospital
Measured: During initial admission to hospital for open fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open FractureStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized controlled trial blinded to participants and end-point assessors. Participants will be randomized to either receiving the treatment, intra-operative intrawound topical vancomycin powder on open fractures in addition to intravenous antibiotics with irrigation and debridement, or the control, intravenous antibiotics with irrigation and debridement alone.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Health Sciences Centre, Winnipeg, Manitoba
- Responsible party
- Principal investigator, Madison Price, University of Manitoba
- Investigators
- Gabriel Larose, MD, MSc, FRCSC, Principal investigator, University of ManitobaMadison Price, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504992
- Sponsor's protocol ID
- HS26510 (B2024:071)
- Acronym
- PIVOT
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Powdered Intrawound Vancomycin in Open Fractures: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06504992
- Acronym / sponsor ID
- PIVOT / HS26510 (B2024:071)
- Conditions
- Open Fracture, Trauma, Infection, Surgical Site, Fractures, Open, Wound Infection, Fractures, Bone
- Keywords
- open fracture, vancomycin, infection, trauma, intrawound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Health Sciences Centre, Winnipeg, Manitoba
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 17 Jul 2024 (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 purpose of this randomized control trial is to compare the rate of post-operative infection in patients with open fractures in upper or lower extremity long bones randomized to receive intra-operative intrawound topical vancomycin powder on their open fractures in addition to the current best practice of intravenous antibiotics with irrigation and debridement compared to intravenous antibiotics with irrigation and debridement alone during definitive operative fixation of the fracture.
Detailed description
Primary Objective:
To evaluate the effect of intra-operative intrawound topical vancomycin powder on open fractures in addition to the current best practice of intravenous antibiotics with irrigation and debridement compared to intravenous antibiotics with irrigation and debridement alone during definitive fixation of the fracture on deep surgical site infection, defined as a post-operative surgical infection requiring return to the operating room for irrigation and debridement with or without hardware removal/revision within the first six months following surgery.
Secondary Objectives:
To evaluate the effect of intra-operative intrawound topical vancomycin powder on superficial surgical site infection, defined as a post-operative infection that required antibiotic treatment but no return to the operating room, readmissions to hospital for post-operative surgical infection (deep or superficial), and hardware failure, defined as hardware loosening, loss of fixation, hardware fracture, or hardware migration, visualized either on imaging or found intra-operatively.
To evaluate differences in microbe characteristics in cultures taken intra-operatively in the take-back irrigation and debridement surgery in patients with deep surgical site infection.
To evaluate if the effect of intra-operative intrawound topical vancomycin powder changes based on fracture and patient characteristics: upper extremity versus lower extremity, Gustilo Classification, patients with documented Methicillin-resistant Staphylococcus aureus (MRSA) colonization, and mechanism of injury.
To evaluate if certain fracture and patient characteristics: upper extremity versus lower extremity, Gustilo Classification, patients with documented Methicillin-resistant Staphylococcus aureus (MRSA) colonization, and by their mechanism of injury increases the risk of infection in both the treatment and control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a randomized controlled trial blinded to participants and end-point assessors. Participants will be randomized to either receiving the treatment, intra-operative intrawound topical vancomycin powder on open fractures in addition to intravenous antibiotics with irrigation and debridement, or the control, intravenous antibiotics with irrigation and debridement alone.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Vancomycin 1000 MGPowdered, intrawound vancomycin 1000 mg at the time of definitive surgery for open fracture fixation in addition to the current best practice of intravenous antibiotics with irrigation and debridement |
| Control | No intervention | –Intravenous antibiotics with irrigation and debridement alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older at time of surgery
- Patients with an open fracture classified as Gustilo Type I to IIIc in the clavicle, humerus, radius, ulna, metacarpals, upper extremity phalanges (fingers), femur, tibia, fibula and metatarsals and lower extremity phalanges (toes).
- Open fracture treated operatively with plate(s) and screw(s) hardware fixation and intramedullary fixation (IM nail).
- Able to attend standard of care follow up for six months post-operatively
Key exclusion criteria (9 listed)
- Patients with known vancomycin allergy, drug administration reaction, or other sensitivities to vancomycin.
- Patients who have already had definitive fracture fixation before enrollment in the study
- Patients with open fracture already infected at time of enrollment
- Patients with current positive blood cultures (bacteremia) at time of enrollment (current, meaning they have not received treatment and now have negative most-recent blood cultures).
- Patients who have other forms of local antibiotics that are left in place at the end of the definitive fixation surgery (e.g., antibiotic loaded cement or polymethyl methacrylate (PMMA) beads)
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 |
|---|---|---|
| Vancomycin 1000 MGAlso: TreatmentPowdered, intrawound vancomycin 1000 mg at the time of definitive surgery for open fracture fixation in addition to the current best practice of intravenous antibiotics with irrigation and debridement | Drug | Treatment |
Primary outcome
Deep surgical site infection
Time frame: Within six months of definitive surgical orthopedic fixation
A post-operative surgical infection requiring return to the operating room for irrigation and debridement with or without hardware removal/revision after the definitive fixation.
7 secondary outcomes
Superficial surgical site infection
Time frame: Within six months of definitive surgical orthopedic fixation
Hardware failure visualized either on imaging or found intra-operatively, until six months post definitive fixation
Time frame: Up until six months following definitive fixation
Microbe sensitivity
Time frame: Up until six months following definitive fixation
Fracture location
Time frame: At time of initial open fracture
Fracture Gustilo Classification
Time frame: At time of definitive surgical orthopedic fixation.
Mechanism of injury
Time frame: At time of initial open fracture
MRSA colonization
Time frame: During initial admission to hospital for open fracture
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Open Fracture
Not yet recruiting
Comparison of GMI, PNF, and Standard Care for Post-Traumatic Elbow Stiffness Rehabilitation in Adults
Elbow Stiffess, Rehabilitation Treatment
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
RecruitingPhase 4
Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures
Opioid Use, Fractures, Bone
Recruiting
Pericapsular Nerve Group (PENG) Block on Postoperative Pain Management After Acetabular Fracture Fixation
Acetabular Fractures
Not yet recruiting
Study on Outcomes of Proximal Humerus Fractures
Proximal Humerus Fracture
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.
Madison Price, MD contact
Gabriel Larose, MD, MSc, FRCSC principal investigator
University of Manitoba
Madison Price, MD principal investigator
University of Manitoba
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 Vancomycin 1000 MG in people with Open Fracture and Trauma, run by University of Manitoba 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 9 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: opening soon, as of the sponsor's last update on 19 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Larose, MD, MSc, FRCSC (2047872261, glarose@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep surgical site infection (time frame: Within six months of definitive surgical orthopedic fixation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2024.