Condition category
Injury, Occupational Diseases, Poisoning
Date applied
09/07/2009
Date assigned
13/07/2009
Last edited
13/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mohit Bhandari

ORCID ID

Contact details

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

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 measures

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

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

http://www.mcmaster.ca/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes