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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Canada

Philippines1 site
  • Philippine Orthopedic Center, Ma. Clara Corner Banawe Street

    Quezon City

Other trials in Philippines

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 groups in NCT02870465
Study groupRoleWhat they receive
CRIF in operating roomPatients 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 roomPatients 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.

  1. 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)
  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.

  1. First posted17 Aug 2016 (estimated)
  2. Study start29 Sep 2016
  3. Primary completion29 Sep 2021
  4. Study completion29 Sep 2021

Resources

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)
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.

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.

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