Fluid Lavage of Open Wounds (FLOW): Pilot Trial

This study has been completed.
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
Orthopaedic Trauma Association
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT01069315
First received: February 16, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Infection
Wound Healing Problem
Nonunion
Procedure: Type of fluid lavage solution
Procedure: Type of fluid lavage pressure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • The number of re-operations (all subsequent operative procedures to treat an infection, a wound healing problem, or a nonunion). [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of all operative and non-operatively managed infections, wound healing problems, and nonunions. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Health- related quality of life and physical function measured by the SF-12 and the EQ-5D questionnaires. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: July 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normal saline and 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 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 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 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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069315

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mohit Bhandari, McMaster University
ClinicalTrials.gov Identifier: NCT01069315     History of Changes
Other Study ID Numbers: 05-299
Study First Received: February 16, 2010
Last Updated: February 16, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
open wound
solution
pressure
randomized

Additional relevant MeSH terms:
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014