Fluid Lavage of Open Wounds (FLOW)

ISRCTN	ISRCTN33993149
DOI	https://doi.org/10.1186/ISRCTN33993149
ClinicalTrials.gov number	NCT00788398
Secondary identifying numbers	MCT-93173; FLOW-01

Submission date: 09/07/2009
Registration date: 13/07/2009
Last edited: 10/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mohit Bhandari
Scientific

293 Wellington Street North, Suite 110
Hamilton, Ontario
L8L 8E7
Canada

Study information

Study design	Multicentre blinded randomised controlled trial, using a 2 x 3 factorial design
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Fluid Lavage of Open Wounds (FLOW): a multicentre, blinded, factorial trial comparing alternative irrigating solutions and pressures in patients with open fractures
Study acronym	FLOW
Study objectives	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(s)	McMaster Faculty of Health Sciences/Hamilton Health Sciences Research Ethics Board approved on the 2nd September 2008 (ref: 08-268)
Health condition(s) or problem(s) studied	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
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 study start date	01/06/2009
Completion date	01/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	2280
Key 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
Key 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
Date of first enrolment	01/06/2009
Date of final enrolment	01/01/2012

Locations

Countries of recruitment

Australia
Canada
United States of America

Study participating centre

293 Wellington Street North, Suite 110

Hamilton, Ontario
L8L 8E7
Canada

Sponsor information

McMaster University (Canada)
University/education

CLARITY Research Group
293 Wellington Street North, Suite 110
Hamilton, Ontario
L8L 8E7
Canada

Website	http://www.mcmaster.ca/
"ROR"	https://ror.org/02fa3aq29

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-93173)

No information available

United States Department of Defense (USA) (Proposal Log No.: 07128039)

No information available

International Association for Dynamic Osteosynthesis (Association Internationale pour I'Ostéosynthèse Dynamique [AIOD]) (France) - Research Grant (ref: 080407-MBES)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol results	06/05/2010	10/04/2019	Yes	No
Results article	results	31/12/2015	10/04/2019	Yes	No
Results article	results	01/01/2019	10/04/2019	Yes	No

Editorial Notes

10/04/2019: Publication reference added.