Fluid Lavage of Open Wounds (FLOW)

Not Applicable

Completed

• Conditions: Open fracture wounds; Injury, Occupational Diseases, Poisoning; Injury of unspecified body region

• Registration Number: ISRCTN33993149
• Lead Sponsor: McMaster University (Canada)

Brief Summary

1. 2010 protocol results in: https://www.ncbi.nlm.nih.gov/pubmed/20459600 (added 10/04/2019) 2. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26448371 (added 10/04/2019) 3. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30579406 (added 10/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-13
• Study Completion: 2012-01-01
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2280

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Re-operation within 12 months post-initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing.

Secondary Outcome Measures

Name	Time	Method
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.