Hand FractureNCT02870465
Hand K-wire Infections in Operating Room Versus Ambulatory Setting
An observational study of Hand Fracture and Infection Due to Internal Fixation Pin, run by Horizon Health Network at 15 sites in 2 countries.
Trial summary
The main objective of this non-interventional, observational study is to analyze the rate and type of infection complications while performing closed reduction internal fixation (CRIF) of hand fractures in the operating room versus an ambulatory setting. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hand Fracture, Infection Due to Internal Fixation Pin
- What is being tested?
- Closed Reduction Internal Fixation
- Type of treatment
- Surgery or procedure
- How many people
- 1,042 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 29 Sep 2016to 29 Sep 2021
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who present to the emergency department or Plastic Surgery clinic after a hand trauma causing a metacarpal or phalangeal fracture.
Who may be able to join
- 1. Adult patients presenting with an acute metacarpal or phalangeal fracture amenable to closed reduction and percutaneous pinning.
Who cannot join
- Fractures that cannot be reduced in a closed manner necessitating open reduction internal fixation
- Multiple fractures or significant injury requiring ORIF by other means - such as plate fixation
- Existing infection
- Pathologic fracture
- CRIF performed during replantation or revascularization of digit
- Concomitant injury (tendon injury, nerve injury, soft tissue loss requiring reconstructive procedure such as graft or flap)
- Other disease according to investigator's judgment
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Canada14 sites
St. Martha's Regional Hospital
Antigonish Nova Scotia, Nova Scotia
Univeristy of Calgary
Calgary, Alberta, T2N 4L7
Dalhousie University
Halifax, Nova Scotia, B3H3A7
McMaster University
Hamilton, Ontario, L8P 3A9
McGill University
Montreal, Quebec
University of Montreal
Montreal, Quebec
Fraser Health
New Westminster, British Columbia
Univeristy of Ottawa
Ottawa, Ontario, K1Y 4E9
Horizon Health Network
Saint John, New Brunswick, E2L 4L4
Saint-Hyacinthe
Saint-Hyacinthe, Quebec
Memorial University
St. John's, Newfoundland and Labrador, A1B 3V6
University of Toronto
Toronto, Ontario
Lion's Gate Hospital
Vancouver, British Columbia, V7L 2P9
University of Manitoba
Winnipeg, Manitoba
Philippines1 site
Philippine Orthopedic Center, Ma. Clara Corner Banawe Street
Quezon City
About this study
Official title: K-wire Infections in Operating Room Sterility Versus Ambulatory Setting Field Sterility: A Prospective Cohort Study
The main objective of this non-interventional, observational study is to analyze the rate and type of infection complications while performing closed reduction internal fixation (CRIF) of hand fractures in the operating room versus an ambulatory setting. The investigators will do so by prospectively collecting data on the type of fracture, handedness, co-morbidities, duration of treatment, number and type of K-wires, duration of fixation and complication rate. Patients presenting with hand fractures to the emergency room will be recruited. Patients will be recruited in multiple centres across Canada and managed according to the institutional standard. The complication type and rate will be recorded and analyzed to determine a difference of performing the procedure in the operating room or clinical setting.
Read the detailed description
The main objective of this study is to analyze the rate and type of infectious complications while performing closed reduction internal fixation (CRIF) of hand fractures in the operating room versus an ambulatory setting. The investigators will do so by prospectively collecting data into a hand fracture database, recording the type of fracture, handedness, co-morbidities, duration of treatment, number of K-wires, duration of fixation and complication rate. These will be recorded on a data collection form, which will be transcribed into a password protected excel spread sheet by Dr. Lalonde. The data will be de-identified and the patients will be assigned a number to place on the data collection sheet depending on order of presentation. The investigators will include all adult patients presenting with a metacarpal or phalangeal that is amenable to CRIF with K-wires.
The investigators will recruit patients prospectively from the emergency room or clinic referrals. All patients who meet the inclusion and exclusion criteria will be asked to participate by the attending surgeon or resident. The patients will be assigned a number according to chronological presentation. The patients will be recruited from academic centers in Canada. Three centers, Halifax, Toronto and McMaster, do not perform CRIF with K-wires in a clinical setting and thus will represent the main operating room cohort. The clinical setting CRIF cohort will be comprised of patients from St. John, Calgary, Ottawa, Vancouver and St John's where CRIF of hand fractures are routinely performed under local anaesthetic and field sterility. The characteristics of the injury, fracture, timing of injury, patient comorbidities which predispose to infections, handedness, smoking status, sex and age will be recorded.
All procedures in the operating room or the clinic area will be performed under the anaesthetic that is standard in that center. A procedure will be deemed "field sterility" if the usual surgical preparation of povidone-iodine or isopropyl alcohol-chlorohexidine gluconate and sterile drape is performed with sterile gloves and masks but without surgical gowns. In the outpatient clinic area, a basic tray will be used along with the K-wire driver and wire-cutters. A mini C-arm fluoroscopy machine is used to visualize the reduction and placement of the K-wires. The patients will then be dressed with a non-antibiotic containing dressing and splinted. The surgical information such as number and type of K-wires, OR time, type of anaesthesia, place of operation, and antibiotic use will be recorded. There will be no additional pin site care offered, as there is no standard accepted method to decrease pin-tract infection. They will be followed up as per the local protocol.
The patients will be instructed that if they are concerned regarding a complication or infection that they must present to their attending surgeon or other plastic surgery colleague covering outpatient calls. They will be provided a contact number for after hours. The necessity to contact the attending team will be stressed to improve documentation of complications and ensure that the proper diagnosis of an infection will be made and appropriate antibiotic coverage started. If the patient is to present to the emergency department or family physician, improper antibiotic coverage may be started for a patient presenting with normal wound healing, which will falsely elevate the incidence of recorded hand infections. The patient will be followed until K-wire removal around 3 to 4 weeks, as per local protocol, and the duration of K-wire fixation will be recorded along with any complications.
- Being tested
- Closed Reduction Internal Fixation
- Keywords
- outpatient versus operating room, k wire infection, closed reduction internal fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed Reduction Internal FixationProcedure or surgery
K-wires placed percutaneously through the skin to achieve fixation of a hand after reduction of the fracture in a closed manner.
| Study group | Role | What they receive |
|---|---|---|
| CRIF in operating room | Patients who present with a hand fracture amendable to closed reduction internal fixation (CRIF) who are managed in the operating room. Receives: Procedure: Closed Reduction Internal Fixation | |
| CRIF outside of operating room | Patients who present with a hand fracture amendable to closed reduction internal fixation (CRIF) who are managed outside of the operating room (i.e.: in clinical setting, the emergency department or minor procedures area). Receives: Procedure: Closed Reduction Internal Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection rate post closed reduction internal fixation
The rate of infections after K-wire fixation of hand fractures. K-wire infection will be diagnosed if two of the three following criteria are met: i) surrounding cellulitis greater than 5mm of diameter around K wire site (more than normal inflammation) ii) purulent drainage from the pin site and iii) bacteriologic evidence of infection (ie: positive cultures). X-ray evidence of osteomyelitis will also be considered for diagnosis of late infection.
Measured: 12 weeks post fixation
Secondary outcomes (1)
Complication rate post closed reduction internal fixation
The rate of other complications after K-wire fixation of hand fractures. These include issues such as malunion and nonunion.
Measured: 12 weeks post fixation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study start29 Sep 2016
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand FractureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,042 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horizon Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Don Lalonde MD, Horizon Health Network
- Investigators
- Donald Lalonde, MD, Principal investigator, Horizon Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870465
- Sponsor's protocol ID
- HHN-1
- Status last verified
- Mar 2022
- First submitted
- 12 Aug 2016
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Patient information will be recorded using a corresponding number based on their order of presentation. The data will be presented or published as an average of all patients in the study.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- K-wire Infections in Operating Room Sterility Versus Ambulatory Setting Field Sterility: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02870465
- Acronym / sponsor ID
- HHN-1
- Keywords
- outpatient versus operating room, k wire infection, closed reduction internal fixation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,042 participants (actual)
- Lead sponsor
- Horizon Health NetworkUniversity, hospital or other
- Study start
- 29 Sep 2016 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 17 Aug 2016 (estimated)
- 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 main objective of this non-interventional, observational study is to analyze the rate and type of infection complications while performing closed reduction internal fixation (CRIF) of hand fractures in the operating room versus an ambulatory setting. The investigators will do so by prospectively collecting data on the type of fracture, handedness, co-morbidities, duration of treatment, number and type of K-wires, duration of fixation and complication rate. Patients presenting with hand fractures to the emergency room will be recruited. Patients will be recruited in multiple centres across Canada and managed according to the institutional standard. The complication type and rate will be recorded and analyzed to determine a difference of performing the procedure in the operating room or clinical setting.
Detailed description
The main objective of this study is to analyze the rate and type of infectious complications while performing closed reduction internal fixation (CRIF) of hand fractures in the operating room versus an ambulatory setting. The investigators will do so by prospectively collecting data into a hand fracture database, recording the type of fracture, handedness, co-morbidities, duration of treatment, number of K-wires, duration of fixation and complication rate. These will be recorded on a data collection form, which will be transcribed into a password protected excel spread sheet by Dr. Lalonde. The data will be de-identified and the patients will be assigned a number to place on the data collection sheet depending on order of presentation. The investigators will include all adult patients presenting with a metacarpal or phalangeal that is amenable to CRIF with K-wires.
The investigators will recruit patients prospectively from the emergency room or clinic referrals. All patients who meet the inclusion and exclusion criteria will be asked to participate by the attending surgeon or resident. The patients will be assigned a number according to chronological presentation. The patients will be recruited from academic centers in Canada. Three centers, Halifax, Toronto and McMaster, do not perform CRIF with K-wires in a clinical setting and thus will represent the main operating room cohort. The clinical setting CRIF cohort will be comprised of patients from St. John, Calgary, Ottawa, Vancouver and St John's where CRIF of hand fractures are routinely performed under local anaesthetic and field sterility. The characteristics of the injury, fracture, timing of injury, patient comorbidities which predispose to infections, handedness, smoking status, sex and age will be recorded.
All procedures in the operating room or the clinic area will be performed under the anaesthetic that is standard in that center. A procedure will be deemed "field sterility" if the usual surgical preparation of povidone-iodine or isopropyl alcohol-chlorohexidine gluconate and sterile drape is performed with sterile gloves and masks but without surgical gowns. In the outpatient clinic area, a basic tray will be used along with the K-wire driver and wire-cutters. A mini C-arm fluoroscopy machine is used to visualize the reduction and placement of the K-wires. The patients will then be dressed with a non-antibiotic containing dressing and splinted. The surgical information such as number and type of K-wires, OR time, type of anaesthesia, place of operation, and antibiotic use will be recorded. There will be no additional pin site care offered, as there is no standard accepted method to decrease pin-tract infection. They will be followed up as per the local protocol.
The patients will be instructed that if they are concerned regarding a complication or infection that they must present to their attending surgeon or other plastic surgery colleague covering outpatient calls. They will be provided a contact number for after hours. The necessity to contact the attending team will be stressed to improve documentation of complications and ensure that the proper diagnosis of an infection will be made and appropriate antibiotic coverage started. If the patient is to present to the emergency department or family physician, improper antibiotic coverage may be started for a patient presenting with normal wound healing, which will falsely elevate the incidence of recorded hand infections. The patient will be followed until K-wire removal around 3 to 4 weeks, as per local protocol, and the duration of K-wire fixation will be recorded along with any complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRIF in operating room | – | Procedure: Closed Reduction Internal FixationPatients who present with a hand fracture amendable to closed reduction internal fixation (CRIF) who are managed in the operating room. |
| CRIF outside of operating room | – | Procedure: Closed Reduction Internal FixationPatients who present with a hand fracture amendable to closed reduction internal fixation (CRIF) who are managed outside of the operating room (i.e.: in clinical setting, the emergency department or minor procedures area). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who present to the emergency department or Plastic Surgery clinic after a hand trauma causing a metacarpal or phalangeal fracture.
Key inclusion criteria (1 listed)
- 1. Adult patients presenting with an acute metacarpal or phalangeal fracture amenable to closed reduction and percutaneous pinning.
Key exclusion criteria (7 listed)
- Fractures that cannot be reduced in a closed manner necessitating open reduction internal fixation
- Multiple fractures or significant injury requiring ORIF by other means - such as plate fixation
- Existing infection
- Pathologic fracture
- CRIF performed during replantation or revascularization of digit
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 |
|---|---|---|
| Closed Reduction Internal FixationK-wires placed percutaneously through the skin to achieve fixation of a hand after reduction of the fracture in a closed manner. | Procedure or surgery | CRIF in operating room, CRIF outside of operating room |
Primary outcome
Infection rate post closed reduction internal fixation
Time frame: 12 weeks post fixation
The rate of infections after K-wire fixation of hand fractures. K-wire infection will be diagnosed if two of the three following criteria are met: i) surrounding cellulitis greater than 5mm of diameter around K wire site (more than normal inflammation) ii) purulent drainage from the pin site and iii) bacteriologic evidence of infection (ie: positive cultures). X-ray evidence of osteomyelitis will also be considered for diagnosis of late infection.
1 secondary outcome
Complication rate post closed reduction internal fixation
Time frame: 12 weeks post fixation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No. Patient information will be recorded using a corresponding number based on their order of presentation. The data will be presented or published as an average of all patients in the 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.
Donald Lalonde, MD principal investigator
Horizon Health Network
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Fracture and Infection Due to Internal Fixation Pin, run by Horizon Health Network at 15 sites in 2 countries.
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 1 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: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada, Philippines. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection rate post closed reduction internal fixation (time frame: 12 weeks post 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 17 Mar 2022.