NCT00788398|CompletedDMC
Fluid Lavage of Open Wounds
FLOW
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FLOW
Sponsor study identifier
Secondary identifiers
interventional
2,540
5 countries
31
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
April 2015
Actual (reported)Open fracture wounds are a constant challenge to orthopaedic surgeons, with infections a common complication. There is currently little evidence as to which is the most effective way to wash out these wounds. This study is a multi-center, prospective, randomized study. The infection rates will be compared between irrigation using high pressure versus low pressure versus gravity flow, and also saline versus a soap solution as the irrigation solution. The results from this study will help to determine the best method of washing out open fractures wounds. In this study, all open wounds will be washed out using methods commonly used by orthopaedic surgeons
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 7, 2008
Actual (reported)November 10, 2008
Actual (reported)June 2009
Date type not reportedThis date has not been verified as actual or estimated.
January 2015
Actual (reported)April 2015
Actual (reported)Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing.
within 12 months
Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D
12 months
Irrigation with Saline
Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)
Univeristy of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of California-Irvine
Orange, California, 92868, United States
University of California- San Francisco
San Francisco, California, 94110, United States
Wishard Health Services, Indiana University
Indianapolis, Indiana, 46202, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 49503, United States
Hennepin County Medical Center
Tornetta P 3rd, Della Rocca GJ, Morshed S, Jones C, Heels-Ansdell D, Sprague S, Petrisor B, Jeray KJ, Del Fabbro G, Bzovsky S, Bhandari M; FLOW Investigators. Risk Factors Associated With Infection in Open Fractures of the Upper and Lower Extremities. J Am Acad Orthop Surg Glob Res Rev. 2020 Dec 8;4(12):e20.00188. doi: 10.5435/JAAOSGlobal-D-20-00188.
Prada C, Marcano-Fernandez FA, Schemitsch EH, Bzovsky S, Jeray K, Petrisor B, Bhandari M, Sprague S; FLOW Investigators. Timing and Management of Surgical Site Infections in Patients With Open Fracture Wounds: A Fluid Lavage of Open Wounds Cohort Secondary Analysis. J Orthop Trauma. 2021 Mar 1;35(3):128-135. doi: 10.1097/BOT.0000000000001912.
Kyle J. Jeray, MD
Greenville Hospital System
Bradley Petrisor, MD
Hamilton Health Sciences Corporation
Mohit Bhandari, MD
McMaster University
Gordan Guyatt, M.D.
McMaster University
2,540 participants (actual enrollment reported by the registry).
First Submitted
November 7, 2008
First Posted
November 10, 2008
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Bupivacaine Application on Postthyroidectomy Pain
Gravity flow irrigation will be standardized across participating centers as 3L bags of normal saline (alone or with soap solution) suspended 6-8 feet above floor level using an I.V. pole. Irrigation tubing (measuring 1/4 - 3/8 inch inner diameter) will be connected to the 3L bag and secured with a stopcock (or compressive device) until ready for use.
Irrigation with the Stryker SurgiLav System. At the low pressure setting delivers 5.9 p.s.i. pressure. The high-flow irrigator tip will be held perpendicular to and 5cm above the wound. Irrigation with the Zimmer PulsaVac. For low pressure delivery, the shower tip will be used at the low pressure setting which delivers a pressure of 5.8 p.s.i.
Irrigation with the Stryker SurgiLav System. For the high pressure delivery, the multi-orifice tip will be used at the high setting which delivers a pressure of 30 p.s.i. Irrigation with the Zimmer PulsaVac System: For the high pressure delivery the shower tip will be used at the high pressure setting which delivers a pressure of 23 p.s.i.
Contact the study team to confirm eligibility.
Minneapolis, Minnesota, 55415, United States
University of Missouri Health Care
Columbia, Missouri, 65212, United States
St. Louis University
St Louis, Missouri, 63110, United States
Duke University
Durham, North Carolina, 27710, United States
Miami Valley Hospital/Wright State University
Dayton, Ohio, 45409, United States
University of Pittsburg
Pittsburgh, Pennsylvania, United States
Greenville Hospital System
Greenville, South Carolina, 29605, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
The Alfred
Prahran, VIC 3181, Australia
Royal Columbian Hospital-New Wesminster
New Westminster, British Columbia, V3L 5P5, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Health Sciences Winnipeg
Winnipeg, Manitoba, R3A 1R9, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 3A7, Canada
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2, Canada
McMaster University
Hamilton, Ontario, Canada
London Health Sciences
London, Ontario, Canada
Ottawa Hospital- Civic
Ottawa, Ontario, K1V 4E9, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5C 1R6, Canada
McGill University Health Centre
Montreal, Quebec, H3G-1A4, Canada
Hospital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5, Canada
Hôpital de l'Enfant-Jésus
Québec, Quebec, Canada
Université de Sherbrooke
Sherbrooke, Quebec, Canada
Sancheti Institute
Prune, India
Ulleval University Hospital
Oslo, Norway
Busse JW, Heels-Ansdell D, Makosso-Kallyth S, Petrisor B, Jeray K, Tufescu T, Laflamme Y, McKay P, McCabe RE, Le Manach Y, Bhandari M; Fluid Lavage of Open Wounds Investigators. Patient coping and expectations predict recovery after major orthopaedic trauma. Br J Anaesth. 2019 Jan;122(1):51-59. doi: 10.1016/j.bja.2018.06.021. Epub 2018 Aug 6.
Sprague S, Tornetta P 3rd, Slobogean GP, O'Hara NN, McKay P, Petrisor B, Jeray KJ, Schemitsch EH, Sanders D, Bhandari M; FLOW Investigators. Are large clinical trials in orthopaedic trauma justified? BMC Musculoskelet Disord. 2018 Apr 20;19(1):124. doi: 10.1186/s12891-018-2029-3.
Shea P, O'Hara NN, Sprague SA, Bhandari M, Petrisor BA, Jeray KJ, Zhan M, Slobogean GP, Pensy RA; Fluid Lavage in Open Wounds Investigators. Wound Surface Area as a Risk Factor for Flap Complications among Patients with Open Fractures. Plast Reconstr Surg. 2018 Jul;142(1):228-236. doi: 10.1097/PRS.0000000000004418.
FLOW Investigators; Bhandari M, Jeray KJ, Petrisor BA, Devereaux PJ, Heels-Ansdell D, Schemitsch EH, Anglen J, Della Rocca GJ, Jones C, Kreder H, Liew S, McKay P, Papp S, Sancheti P, Sprague S, Stone TB, Sun X, Tanner SL, Tornetta P 3rd, Tufescu T, Walter S, Guyatt GH. A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds. N Engl J Med. 2015 Dec 31;373(27):2629-41. doi: 10.1056/NEJMoa1508502. Epub 2015 Oct 8.
Flow Investigators. Fluid lavage of open wounds (FLOW): design and rationale for a large, multicenter collaborative 2 x 3 factorial trial of irrigating pressures and solutions in patients with open fractures. BMC Musculoskelet Disord. 2010 May 6;11:85. doi: 10.1186/1471-2474-11-85.
Primary Completion
January 2015
Actual (reported)Study Completion
April 2015
Actual (reported)Last Updated
February 11, 2016
Record last verified: 2016-02
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