Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00788398
Protocol/serial number
MCT-93173; FLOW-01
Study information
Scientific title
Fluid Lavage of Open Wounds (FLOW): a multicentre, blinded, factorial trial comparing alternative irrigating solutions and pressures in patients with open fractures
Acronym
FLOW
Study hypothesis
1. In patients operatively treated for open fractures of the extremity, irrigation with soap will result in lower rates of re-operations within one year after initial surgery as compared to saline
2. In patients operatively treated for open fractures of the extremity, irrigation at low pressure will result in lower rates of re-operations within one year after initial surgery as compared to high pressure
Ethics approval
McMaster Faculty of Health Sciences/Hamilton Health Sciences Research Ethics Board approved on the 2nd September 2008 (ref: 08-268)
Study design
Multicentre blinded randomised controlled trial, using a 2 x 3 factorial design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Open fracture wounds
Intervention
Irrigation of open fracture wound with one of the following:
1. Saline solution delivered at gravity pressure (1 - 2 psi)
2. Saline solution delivered with an irrigator at low pressure (5 - 10 psi)
3. Saline solution delivered with an irrigator at high pressure (greater than 20 psi)
4. Castile soap solution (80 ml per 3 litres saline) delivered at gravity pressure (1 - 2 psi)
5. Castile soap solution (80 ml per 3 litres saline) delivered with an irrigator at low pressure (5 - 10 psi)
6. Castile soap solution (80 ml per 3 litres saline) delivered with an irrigator at high pressure (greater than 20 psi)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Re-operation within 12 months post-initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing.
Secondary outcome measures
Patient function and quality of life measured by the 12-item Short Form (SF-12) and the EuroQol-5D, assessed at 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months.
Overall trial start date
01/06/2009
Overall trial end date
01/01/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men or women who are 18 years of age or older
2. Fracture of any extremity with complete radiographs
3. Open fractures (Gustilo-Anderson Types I-IIIB)
4. Fracture requiring operative fixation
5. Provision of informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2280
Participant exclusion criteria
1. Open fractures with an associated vascular deficit (Gustilo-Anderson Type IIIC)
2. Known allergy to detergents or castile soap ingredients
3. Previous wound infection or history of osteomyelitis in the injured extremity
4. Previous fracture with retained hardware in injured extremity that will interfere with new implant fixation
5. Surgical delay to operative wound management greater than 24 hours from hospital admission
6. Use of immunosuppressive medication within 6 months
7. Immunological deficient disease conditions (e.g., human immunodeficiency virus [HIV])
8. Fracture of the hand (metacarpals and phalanges)
9. Fracture of the toes (phalanges)
10. Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
11. Previous randomisation in this study or a competing study
12. Patient is a prisoner or is at high risk of incarceration during the follow-up period
Recruitment start date
01/06/2009
Recruitment end date
01/01/2012
Locations
Countries of recruitment
Australia, Canada, United States of America
Trial participating centre
293 Wellington Street North, Suite 110
Hamilton, Ontario
L8L 8E7
Canada
Sponsor information
Organisation
McMaster University (Canada)
Sponsor details
CLARITY Research Group
293 Wellington Street North
Suite 110
Hamilton
Ontario
L8L 8E7
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-93173)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
United States Department of Defense (USA) (Proposal Log No.: 07128039)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
International Association for Dynamic Osteosynthesis (Association Internationale pour I'Ostéosynthèse Dynamique [AIOD]) (France) - Research Grant (ref: 080407-MBES)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list