Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2540 participants
INTERVENTIONAL
2009-06-30
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Saline, gravity flow
Saline Solution
Irrigation with Saline
Gravity Flow Irrigation
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.
Saline, Low Pressure
Saline Solution
Irrigation with Saline
Low Pressure Irrigation
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.
Saline, High Pressure
Saline Solution
Irrigation with Saline
High Pressure
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.
Soap, Gravity Flow
Soap solution
Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)
Gravity Flow Irrigation
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.
Soap, low pressure
Soap solution
Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)
Low Pressure Irrigation
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.
Soap, high pressure
Soap solution
Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)
High Pressure
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.
Interventions
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Saline Solution
Irrigation with Saline
Soap solution
Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)
Gravity Flow Irrigation
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.
Low Pressure Irrigation
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.
High Pressure
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.
Eligibility Criteria
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Inclusion Criteria
2. Fracture of any extremity with complete radiographs.
3. Open fractures (Gustilo-Anderson Types I-IIIB) (Table 2)\*.
4. Fracture requiring operative fixation.
5. Provision of informed consent.
Exclusion Criteria
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. 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 randomization in this study or a competing study.
14 Years
85 Years
ALL
No
Sponsors
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McMaster University
OTHER
United States Department of Defense
FED
Prisma Health-Upstate
OTHER
Responsible Party
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Principal Investigators
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Kyle J. Jeray, MD
Role: PRINCIPAL_INVESTIGATOR
Greenville Hospital System
Bradley Petrisor, MD
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences Corporation
Mohit Bhandari, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Gordan Guyatt, M.D.
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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Univeristy of Alabama at Birmingham
Birmingham, Alabama, United States
University of California-Irvine
Orange, California, United States
University of California- San Francisco
San Francisco, California, United States
Wishard Health Services, Indiana University
Indianapolis, Indiana, United States
Lahey Clinic
Burlington, Massachusetts, United States
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
University of Missouri Health Care
Columbia, Missouri, United States
St. Louis University
St Louis, Missouri, United States
Duke University
Durham, North Carolina, United States
Miami Valley Hospital/Wright State University
Dayton, Ohio, United States
University of Pittsburg
Pittsburgh, Pennsylvania, United States
Greenville Hospital System
Greenville, South Carolina, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
The Alfred
Prahran, , Australia
Royal Columbian Hospital-New Wesminster
New Westminster, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Health Sciences Winnipeg
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
McMaster University
Hamilton, Ontario, Canada
London Health Sciences
London, Ontario, Canada
Ottawa Hospital- Civic
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Hospital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Hôpital de l'Enfant-Jésus
Québec, Quebec, Canada
Université de Sherbrooke
Sherbrooke, Quebec, Canada
Sancheti Institute
Prune, , India
Ulleval University Hospital
Oslo, , Norway
Countries
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References
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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.
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.
Other Identifiers
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W81XWH-08-1-0473
Identifier Type: -
Identifier Source: secondary_id
GHS-03-08-06
Identifier Type: -
Identifier Source: org_study_id
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