Fluid Lavage of Open Wounds - Full Text View

Purpose

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	Intervention
Open Fracture Wounds	Procedure: Saline Solution Procedure: Soap solution Procedure: Gravity Flow Irrigation Procedure: Low Pressure Irrigation Procedure: High Pressure

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by Greenville Hospital System University Medical Center:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	2280
Study Start Date:	June 2009
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	14 Years to 85 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788398

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Locations

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
McMaster University
Hamilton, Ontario, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
London Health Sciences
London, Ontario, Canada
Ottawa Hospital- Civic
Ottawa, Ontario, Canada, K1V 4E9
St. Michael's Hospital
Toronto, Ontario, Canada, M5C 1R6
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
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

Greenville Hospital System University Medical Center

McMaster University

Department of Defense

Investigators

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

No publications provided by Greenville Hospital System University Medical Center

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

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.

Responsible Party:	Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier:	NCT00788398 History of Changes
Other Study ID Numbers:	GHS-03-08-06, W81XWH-08-1-0473
Study First Received:	November 7, 2008
Last Updated:	March 11, 2013
Health Authority:	United States: Institutional Review Board Canada: Ethics Review Committee

Additional relevant MeSH terms:

Fractures, Bone
Fractures, Open
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013

Fluid Lavage of Open Wounds (FLOW)