Hand K-wire Infections in Operating Room Versus Ambulatory Setting

NCT02870465 | Completed

• 1 other identifier: HHN-1
• Study Type: observational
• Target: 1,042
• Locations: 2 countries
• Sites: 15

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.

Conditions

Hand Fracture; Infection Due to Internal Fixation Pin

Keywords

outpatient versus operating room; k wire infection; closed reduction internal fixation

Outcome Measures

Primary Outcomes (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.

  12 weeks post fixation

Secondary Outcomes (1)

• Complication rate post closed reduction internal fixation

  12 weeks post fixation

Study Arms (2)

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.

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).

Procedure: Closed Reduction Internal Fixation

Interventions

Closed Reduction Internal Fixation PROCEDURE

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

CRIF in operating room; CRIF outside of operating room

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who present to the emergency department or Plastic Surgery clinic after a hand trauma causing a metacarpal or phalangeal fracture.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Horizon Health Network: lead

Study Sites (15)

Univeristy of Calgary

Calgary, Alberta, T2N 4L7, Canada

Location

Fraser Health

New Westminster, British Columbia, Canada

Location

Lion's Gate Hospital

Vancouver, British Columbia, V7L 2P9, Canada

Location

University of Manitoba

Winnipeg, Manitoba, Canada

Location

Horizon Health Network

Saint John, New Brunswick, E2L 4L4, Canada

Location

Memorial University

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

St. Martha's Regional Hospital

Antigonish, Nova Scotia, Canada

Location

Dalhousie University

Halifax, Nova Scotia, B3H3A7, Canada

Location

McMaster University

Hamilton, Ontario, L8P 3A9, Canada

Location

Univeristy of Ottawa

Ottawa, Ontario, K1Y 4E9, Canada

Location

University of Toronto

Toronto, Ontario, Canada

Location

McGill University

Montreal, Quebec, Canada

Location

University of Montreal

Montreal, Quebec, Canada

Location

Saint-Hyacinthe

Saint-Hyacinthe, Quebec, Canada

Location

Philippine Orthopedic Center, Ma. Clara Corner Banawe Street

Quezon City, Philippines

Location

Study Officials

• Donald Lalonde, MD

  Horizon Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 17, 2016
• Study Start: September 29, 2016
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1); CA (14)