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Completed

NCT Number: NCT01069315

Fluid Lavage of Open Wounds (FLOW): Pilot Trial

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.

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Key information

Conditions

Infection Infections Nonunion Wound Healing Problem

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Type of fluid lavage solution

Procedure

Comparison of castile soap solution vs. normal saline solution.

Type of fluid lavage pressure

Procedure

Comparison of low pressure vs. high pressure.

Primary outcomes

  1. The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion).

    Time frame: one year

Secondary outcomes

  1. The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions.

    Time frame: 1 year

  2. 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).

    Time frame: 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.

  3. 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).

    Time frame: 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.

  4. 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)

    Time frame: 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.

  5. 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Orthopaedic Trauma Association
  • The Physicians' Services Incorporated Foundation

Registry information

Official study 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

Acronym: FLOW

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 17, 2010
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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