Fluid Lavage of Open Wounds (FLOW): Pilot Trial
- Conditions
- Wound Healing ProblemNonunionInfection
- Interventions
- Procedure: Type of fluid lavage solutionProcedure: Type of fluid lavage pressure
- Registration Number
- NCT01069315
- Lead Sponsor
- McMaster University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
- skeletally mature
- sustained an open fracture of the appendicular skeleton (type I to IIIb).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Soap solution and High pressure Type of fluid lavage solution Irrigation with soap solution delivered at high pressure Normal saline and Low pressure Type of fluid lavage pressure Irrigation with saline solution delivered at low pressure Normal saline and High pressure Type of fluid lavage solution Irrigation with normal saline delivered at high pressure Soap solution and High pressure Type of fluid lavage pressure Irrigation with soap solution delivered at high pressure Normal saline and Low pressure Type of fluid lavage solution Irrigation with saline solution delivered at low pressure Soap solution and Low pressure Type of fluid lavage pressure Irrigation with soap solution delivered at low pressure Normal saline and High pressure Type of fluid lavage pressure Irrigation with normal saline delivered at high pressure Soap solution and Low pressure Type of fluid lavage solution Irrigation with soap solution delivered at low pressure
- Primary Outcome Measures
Name Time Method The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion). one year
- Secondary Outcome Measures
Name Time Method 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). 1 year Solution and pressure were analyzed separately for this outcome. The SF-12 summary scores (PCS-12 and MCS-12) ranges from 0 to 100. Higher scores indicate that a person has better health status, while lower scores indicate poorer health status. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.
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) one year Solution and pressure were analyzed separately for this outcome. The SF-12 summary scores (PCS-12 and MCS-12) ranges from 0 to 100. Higher scores indicate that a person has better health status, while lower scores indicate poorer health status. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.
The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. 1 year 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). one year Solution and pressure were analyzed separately for this outcome. The EQ-5D summary score ranges from 0 to 1. Higher scores indicate that a person has a better health-related quality of life, while lower scores indicate worse health-related quality of life. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.
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) one year Solution and pressure were analyzed separately for this outcome. The EQ-5D summary score ranges from 0 to 1. Higher scores indicate that a person has a better health-related quality of life, while lower scores indicate worse health-related quality of life. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months.
Trial Locations
- Locations (9)
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
University of Missouri Health Care
🇺🇸Columbia, Missouri, United States
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Ottawa Hospital - Civic Campus
🇨🇦Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
East Texas Medical Centre
🇺🇸Tyler, Texas, United States
Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Sancheti Institute for Orthopaedics & Rehabilitation
🇮🇳Pune, Maharashtra, India
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada