Hand K-wire Infections in Operating Room Versus Ambulatory Setting

Hand Fracture Clinical Trial

Official title:

K-wire Infections in Operating Room Sterility Versus Ambulatory Setting Field Sterility: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870465
• Other study ID #: HHN-1
• Status: Completed
• Start date: September 29, 2016
• Est. completion date: September 29, 2021

Study information

• Verified date: March 2022
• Source: Horizon Health Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1042
• Est. completion date: September 29, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients presenting with an acute metacarpal or phalangeal fracture amenable to closed reduction and percutaneous pinning.

Exclusion Criteria:

1. Fractures that cannot be reduced in a closed manner necessitating open reduction internal fixation

2. Multiple fractures or significant injury requiring ORIF by other means - such as plate fixation

3. Existing infection

4. Pathologic fracture

5. CRIF performed during replantation or revascularization of digit

6. Concomitant injury (tendon injury, nerve injury, soft tissue loss requiring reconstructive procedure such as graft or flap)

7. Other disease according to investigator's judgment

Related Conditions & MeSH terms

• Communicable Diseases
• Hand Fracture
• Infection Due to Internal Fixation Pin
• Infections

Intervention

Procedure:
• Closed Reduction Internal Fixation
K-wires placed percutaneously through the skin to achieve fixation of a hand after reduction of the fracture in a closed manner.

Locations

Country	Name	City	State
Canada	St. Martha's Regional Hospital	Antigonish	Nova Scotia
Canada	Univeristy of Calgary	Calgary	Alberta
Canada	Dalhousie University	Halifax	Nova Scotia
Canada	McMaster University	Hamilton	Ontario
Canada	McGill University	Montréal	Quebec
Canada	University of Montreal	Montréal	Quebec
Canada	Fraser Health	New Westminster	British Columbia
Canada	Univeristy of Ottawa	Ottawa	Ontario
Canada	Horizon Health Network	Saint John	New Brunswick
Canada	Saint-Hyacinthe	Saint-Hyacinthe	Quebec
Canada	Memorial University	St. John's	Newfoundland and Labrador
Canada	University of Toronto	Toronto	Ontario
Canada	Lion's Gate Hospital	Vancouver	British Columbia
Canada	University of Manitoba	Winnipeg	Manitoba
Philippines	Philippine Orthopedic Center, Ma. Clara Corner Banawe Street	Quezon City

Sponsors (1)

Lead Sponsor	Collaborator
Horizon Health Network

Countries where clinical trial is conducted

Canada,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks post fixation
Secondary	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.	12 weeks post fixation