Clinical trial NCT01069315: Fluid Lavage of Open Wounds (FLOW): Pilot Trial
Official title: Fluid Lavage of Open Wounds (FLOW): A Multi-Center, Blinded, Factorial Pilot Trial Comparing Alternative Irrigating Solutions and Pressures in Patients With Open Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Wound Healing Problem
Nonunion
Keywords: open wound
solution
pressure
randomized
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
name: Orthopaedic Trauma Association
First posted: 2010-02-17
Enrollment: 111
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to investigate whether irrigation solution (soap vs. saline solution), or irrigation pressure (high vs. low) will decrease the rate of infection among patients with open fracture wounds.

Detailed description: Open fractures are an important source of morbidity and are associated with delayed union, nonunion, and infection. Preventing infection through meticulous irrigation and debridement is an important goal in management, and different lavage fluids and irrigation techniques (e.g. high or low pressure lavage) have been described for this purpose. There are, however, a limited number of randomized trials comparing irrigating solutions or irrigating technique. We compared the use of castile soap versus normal saline, as well as high versus low pressure pulsatile lavage on the rates of reoperations and complications in patients with open fracture wounds.

Eligibility criteria: Inclusion Criteria:

* skeletally mature
* sustained an open fracture of the appendicular skeleton (type I to IIIb).

Exclusion Criteria:

* vascular deficit
* \[any\] allergy to detergents or castile soap
* previous wound infection or osteomyelitis
* previous fracture with retained hardware in the injured extremity
* operative management more than 24 hours after injury
* use of immunosuppressive medication within six months
* immunological deficiency or disease conditions
* fractures of the hands (distal to the carpus) or toes

Primary outcomes:
measure: The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion).
timeFrame: one year
Secondary outcomes:
measure: The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions.
timeFrame: 1 year
measure: Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the SF-12 Questionnaire (Solution).
timeFrame: 1 year
measure: Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the EQ-5D Questionnaire (Solution).
timeFrame: one year
measure: Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the SF-12 Questionnaire (Pressure)
timeFrame: one year
measure: Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the EQ-5D Questionnaire (Pressure)
timeFrame: one year
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Tyler
country: United States
facility: East Texas Medical Centre
state: Texas
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital - Civic Campus
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Pune
country: India
facility: Sancheti Institute for Orthopaedics & Rehabilitation
state: Maharashtra
Study officials:
affiliation: McMaster University
name: Mohit Bhandari, MD, FRCSC
role: STUDY_CHAIR
affiliation: McMaster University
name: Mohit Bhandari, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Gordon Guyatt, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Kyle J Jeray, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
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