Fluid Lavage of Open Wounds
FLOW
2 other identifiers
interventional
2,540
5 countries
31
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2009
Longer than P75 for not_applicable
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2008
CompletedFirst Posted
Study publicly available on registry
November 10, 2008
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFebruary 11, 2016
February 1, 2016
5.6 years
November 7, 2008
February 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing.
within 12 months
Secondary Outcomes (1)
Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D
12 months
Study Arms (6)
Saline, gravity flow
ACTIVE COMPARATORSaline, Low Pressure
ACTIVE COMPARATORSaline, High Pressure
ACTIVE COMPARATORSoap, Gravity Flow
ACTIVE COMPARATORSoap, low pressure
ACTIVE COMPARATORSoap, high pressure
ACTIVE COMPARATORInterventions
Irrigation with Saline
Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)
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.
Eligibility Criteria
You may qualify if:
- Men or women who are skeletally mature.
- Fracture of any extremity with complete radiographs.
- Open fractures (Gustilo-Anderson Types I-IIIB) (Table 2)\*.
- Fracture requiring operative fixation.
- Provision of informed consent.
You may not qualify if:
- Open fractures with an associated vascular deficit (Gustilo-Anderson Type IIIC).
- Known allergy to detergents or castile soap ingredients.
- Previous wound infection or history of osteomyelitis in the injured extremity.
- Previous fracture with retained hardware in injured extremity that will interfere with new implant fixation.
- Surgical delay to operative wound management greater than 24 hours from hospital admission.
- Use of immunosuppressive medication within 6 months.
- Immunological deficient disease conditions (e.g. HIV).
- Fracture of the hand (metacarpals and phalanges).
- Fracture of the toes (phalanges).
- 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.
- Previous randomization in this study or a competing study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prisma Health-Upstatelead
- McMaster Universitycollaborator
- United States Department of Defensecollaborator
Study Sites (31)
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
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
Related Publications (7)
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.
PMID: 33986214DERIVEDPrada 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.
PMID: 33105456DERIVEDBusse 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.
PMID: 30579406DERIVEDSprague 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.
PMID: 29678204DERIVEDShea 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.
PMID: 29608532DERIVEDFLOW 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.
PMID: 26448371DERIVEDFlow 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.
PMID: 20459600DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyle J. Jeray, MD
Greenville Hospital System
- PRINCIPAL INVESTIGATOR
Bradley Petrisor, MD
Hamilton Health Sciences Corporation
- PRINCIPAL INVESTIGATOR
Mohit Bhandari, MD
McMaster University
- PRINCIPAL INVESTIGATOR
Gordan Guyatt, M.D.
McMaster University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2008
First Posted
November 10, 2008
Study Start
June 1, 2009
Primary Completion
January 1, 2015
Study Completion
April 1, 2015
Last Updated
February 11, 2016
Record last verified: 2016-02