Fluid Lavage of Open Wounds (FLOW): Pilot Trial (FLOW)

March 15, 2019 updated by: McMaster University

Fluid Lavage of Open Wounds (FLOW): A Multi-Center, Blinded, Factorial Pilot Trial Comparing Alternative Irrigating Solutions and Pressures in Patients With Open Fractures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2A7
        • Queen Elizabeth II Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8L 8E7
        • Hamilton Health Sciences
      • Ottawa, Ontario, Canada
        • Ottawa Hospital - Civic Campus
      • Toronto, Ontario, Canada
        • St. Michael's Hospital
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre
  • India
    • Maharashtra
      • Pune, Maharashtra, India
        • Sancheti Institute for Orthopaedics & Rehabilitation
  • United States
    • Missouri
      • Columbia, Missouri, United States
        • University of Missouri Health Care
    • South Carolina
      • Greenville, South Carolina, United States
        • Greenville Hospital System
    • Texas
      • Tyler, Texas, United States
        • East Texas Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normal saline and High pressure
Irrigation with normal saline delivered at high pressure
Procedure: Type of fluid lavage solution
Comparison of castile soap solution vs. normal saline solution.
Procedure: Type of fluid lavage pressure
Comparison of low pressure vs. high pressure.
Experimental: Soap solution and High pressure
Irrigation with soap solution delivered at high pressure
Procedure: Type of fluid lavage solution
Comparison of castile soap solution vs. normal saline solution.
Procedure: Type of fluid lavage pressure
Comparison of low pressure vs. high pressure.
Experimental: Normal saline and Low pressure
Irrigation with saline solution delivered at low pressure
Procedure: Type of fluid lavage solution
Comparison of castile soap solution vs. normal saline solution.
Procedure: Type of fluid lavage pressure
Comparison of low pressure vs. high pressure.
Experimental: Soap solution and Low pressure
Irrigation with soap solution delivered at low pressure
Procedure: Type of fluid lavage solution
Comparison of castile soap solution vs. normal saline solution.
Procedure: Type of fluid lavage pressure
Comparison of low pressure vs. high pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions.
Time Frame: 1 year
1 year
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.
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).
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.
one year
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.
one 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 (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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

The Physicians' Services Incorporated Foundation
Orthopaedic Trauma Association

Investigators

  • Study Chair: Mohit Bhandari, MD, FRCSC, McMaster University
  • Principal Investigator: Mohit Bhandari, MD, FRCSC, McMaster University
  • Principal Investigator: Gordon Guyatt, MD, FRCSC, McMaster University
  • Principal Investigator: Kyle J Jeray, MD, FRCSC, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (Estimate)

February 17, 2010

Study Record Updates

Last Update Posted (Actual)

March 18, 2019

Last Update Submitted That Met QC Criteria

March 15, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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