Hand K-wire Infections in Operating Room Versus Ambulatory Setting

NCT ID: NCT02870465

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1042 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-29
• Study Completion Date: 2021-09-29

Brief 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.

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.

Conditions

Hand Fracture; Infection Due to Internal Fixation Pin

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Closed Reduction Internal Fixation

Intervention Type: PROCEDURE

K-wires placed percutaneously through the skin to achieve fixation of a hand after reduction of the fracture in a closed manner.

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).

Closed Reduction Internal Fixation

Intervention Type: PROCEDURE

K-wires placed percutaneously through the skin to achieve fixation of a hand after reduction of the fracture in a closed manner.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Horizon Health Network

OTHER

Sponsor Role: lead

Responsible Party

Don Lalonde MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donald Lalonde, MD

Role: PRINCIPAL_INVESTIGATOR

Horizon Health Network

Locations

Univeristy of Calgary

Calgary, Alberta, Canada

Fraser Health

New Westminster, British Columbia, Canada

Lion's Gate Hospital

Vancouver, British Columbia, Canada

University of Manitoba

Winnipeg, Manitoba, Canada

Horizon Health Network

Saint John, New Brunswick, Canada

Memorial University

St. John's, Newfoundland and Labrador, Canada

St. Martha's Regional Hospital

Antigonish, Nova Scotia, Canada

Dalhousie University

Halifax, Nova Scotia, Canada

McMaster University

Hamilton, Ontario, Canada

Univeristy of Ottawa

Ottawa, Ontario, Canada

University of Toronto

Toronto, Ontario, Canada

McGill University

Montreal, Quebec, Canada

University of Montreal

Montreal, Quebec, Canada

Saint-Hyacinthe

Saint-Hyacinthe, Quebec, Canada

Philippine Orthopedic Center, Ma. Clara Corner Banawe Street

Quezon City, , Philippines

Countries

Canada; Philippines

Other Identifiers

HHN-1

Identifier Type: -

Identifier Source: org_study_id