Fluid Lavage of Open Wounds (FLOW)

Fluid Lavage of Open Wounds (FLOW): A Multi-center, Blinded, Factorial Trial Comparing Alternative Irrigating Solutions and Pressures in Patients With Open Fractures

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

Study Overview

• Status: Completed
• Conditions: Open Fracture Wounds
• Intervention / Treatment: Procedure: Saline Solution; Procedure: Gravity Flow Irrigation; Procedure: Low Pressure Irrigation; Procedure: High Pressure; Procedure: Soap solution

• Study Type: Interventional
• Enrollment (Actual): 2540
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men or women who are skeletally mature.
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:

1. Open fractures with an associated vascular deficit (Gustilo-Anderson Type IIIC).
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / 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: 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.; Procedure: Soap solution; Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)
Active Comparator: Soap, low pressure	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.; Procedure: Soap solution; Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)
Active Comparator: Soap, high pressure	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.; Procedure: Soap solution; Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Collaborators: United States Department of Defense; McMaster University
• Investigators: Principal Investigator: Kyle J. Jeray, MD, Greenville Hospital System; Principal Investigator: Bradley Petrisor, MD, Hamilton Health Sciences Corporation; Principal Investigator: Gordan Guyatt, M.D., McMaster University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: November 7, 2008
• First Submitted That Met QC Criteria: November 7, 2008
• First Posted (Estimate): November 10, 2008

Study Record Updates

• Last Update Posted (Estimate): February 11, 2016
• Last Update Submitted That Met QC Criteria: February 10, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Open; Pharmaceutical Solutions
• Other Study ID Numbers: GHS-03-08-06; W81XWH-08-1-0473