Fluid Lavage of Open Wounds (FLOW)

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ClinicalTrials.gov Identifier: NCT00788398

Recruitment Status : Completed

First Posted : November 10, 2008

Last Update Posted : February 11, 2016

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

McMaster University

United States Department of Defense

Information provided by (Responsible Party):

Prisma Health-Upstate

Study Description

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

Condition or disease	Intervention/treatment	Phase
Open Fracture Wounds	Procedure: Saline Solution Procedure: Soap solution Procedure: Gravity Flow Irrigation Procedure: Low Pressure Irrigation Procedure: High Pressure	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2540 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Fluid Lavage of Open Wounds (FLOW): A Multi-center, Blinded, Factorial Trial Comparing Alternative Irrigating Solutions and Pressures in Patients With Open Fractures
Study Start Date :	June 2009
Actual Primary Completion Date :	January 2015
Actual Study Completion Date :	April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures Wounds and Injuries

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Saline, gravity flow	Procedure: Saline Solution Irrigation with Saline Procedure: 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.
Active Comparator: Saline, Low Pressure	Procedure: Saline Solution Irrigation with Saline Procedure: 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.
Active Comparator: Saline, High Pressure	Procedure: Saline Solution Irrigation with Saline Procedure: 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.
Active Comparator: Soap, Gravity Flow	Procedure: Soap solution Irrigation with Castile Soap Solution (80 ml per 3L bag of saline) Procedure: 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.
Active Comparator: Soap, low pressure	Procedure: Soap solution Irrigation with Castile Soap Solution (80 ml per 3L bag of saline) Procedure: 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.
Active Comparator: Soap, high pressure	Procedure: Soap solution Irrigation with Castile Soap Solution (80 ml per 3L bag of saline) Procedure: 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:	14 Years to 85 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788398

Locations

Show 31 study locations

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United States, Alabama
Univeristy of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California-Irvine
Orange, California, United States, 92868
University of California- San Francisco
San Francisco, California, United States, 94110
United States, Indiana
Wishard Health Services, Indiana University
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Michigan
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
University of Missouri Health Care
Columbia, Missouri, United States, 65212
St. Louis University
St. Louis, Missouri, United States, 63110
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Miami Valley Hospital/Wright State University
Dayton, Ohio, United States, 45409
United States, Pennsylvania
University of Pittsburg
Pittsburg, Pennsylvania, United States
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Australia
The Alfred
Prahran, Australia, VIC 3181
Canada, British Columbia
Royal Columbian Hospital-New Wesminster
New Westminster, British Columbia, Canada, V3L 5P5
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Health Sciences Winnipeg
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
McMaster University
Hamilton, Ontario, Canada
London Health Sciences
London, Ontario, Canada
Ottawa Hospital- Civic
Ottawa, Ontario, Canada, K1V 4E9
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5C 1R6
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H3G-1A4
Hospital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Université de Sherbrooke
Sherbrooke, Quebec, Canada
Canada
Hôpital de l'Enfant-Jésus
Quebec, Canada
India
Sancheti Institute
Prune, India
Norway
Ulleval University Hospital
Oslo, Norway

Sponsors and Collaborators

Prisma Health-Upstate

McMaster University

United States Department of Defense

Investigators

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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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Prisma Health-Upstate
ClinicalTrials.gov Identifier:	NCT00788398
Other Study ID Numbers:	GHS-03-08-06 W81XWH-08-1-0473
First Posted:	November 10, 2008 Key Record Dates
Last Update Posted:	February 11, 2016
Last Verified:	February 2016

Additional relevant MeSH terms:

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Wounds and Injuries Fractures, Open Fractures, Bone Pharmaceutical Solutions

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