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Fluid Lavage of Open Wounds (FLOW)

Primary Purpose

Open Fracture Wounds

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Saline Solution
Soap solution
Gravity Flow Irrigation
Low Pressure Irrigation
High Pressure
Sponsored by
Prisma Health-Upstate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Fracture Wounds

Eligibility Criteria

14 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univeristy of Alabama at Birmingham
  • University of California-Irvine
  • University of California- San Francisco
  • Wishard Health Services, Indiana University
  • Lahey Clinic
  • Orthopaedic Associates of Michigan
  • Hennepin County Medical Center
  • University of Missouri Health Care
  • St. Louis University
  • Duke University
  • Miami Valley Hospital/Wright State University
  • University of Pittsburg
  • Greenville Hospital System
  • Brooke Army Medical Center
  • The Alfred
  • Royal Columbian Hospital-New Wesminster
  • Vancouver General Hospital
  • Health Sciences Winnipeg
  • Queen Elizabeth II Health Sciences Center
  • Hamilton Health Sciences
  • McMaster University
  • London Health Sciences
  • Ottawa Hospital- Civic
  • Sunnybrook Health Sciences Centre
  • St. Michael's Hospital
  • McGill University Health Centre
  • Hospital du Sacre-Coeur de Montreal
  • Université de Sherbrooke
  • Hôpital de l'Enfant-Jésus
  • Sancheti Institute
  • Ulleval University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Saline, gravity flow

Saline, Low Pressure

Saline, High Pressure

Soap, Gravity Flow

Soap, low pressure

Soap, high pressure

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D

Full Information

First Posted
November 7, 2008
Last Updated
February 10, 2016
Sponsor
Prisma Health-Upstate
Collaborators
McMaster University, United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT00788398
Brief Title
Fluid Lavage of Open Wounds
Acronym
FLOW
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 Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prisma Health-Upstate
Collaborators
McMaster University, United States Department of Defense

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Fracture Wounds

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
2540 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saline, gravity flow
Arm Type
Active Comparator
Arm Title
Saline, Low Pressure
Arm Type
Active Comparator
Arm Title
Saline, High Pressure
Arm Type
Active Comparator
Arm Title
Soap, Gravity Flow
Arm Type
Active Comparator
Arm Title
Soap, low pressure
Arm Type
Active Comparator
Arm Title
Soap, high pressure
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Saline Solution
Intervention Description
Irrigation with Saline
Intervention Type
Procedure
Intervention Name(s)
Soap solution
Intervention Description
Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)
Intervention Type
Procedure
Intervention Name(s)
Gravity Flow Irrigation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Low Pressure Irrigation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
High Pressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle J. Jeray, MD
Organizational Affiliation
Greenville Hospital System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bradley Petrisor, MD
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohit Bhandari, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gordan Guyatt, M.D.
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California-Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California- San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Wishard Health Services, Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Orthopaedic Associates of Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
St. Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Miami Valley Hospital/Wright State University
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
University of Pittsburg
City
Pittsburg
State/Province
Pennsylvania
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
The Alfred
City
Prahran
ZIP/Postal Code
VIC 3181
Country
Australia
Facility Name
Royal Columbian Hospital-New Wesminster
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 5P5
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Health Sciences Winnipeg
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences
City
London
State/Province
Ontario
Country
Canada
Facility Name
Ottawa Hospital- Civic
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1V 4E9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 1R6
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G-1A4
Country
Canada
Facility Name
Hospital du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Université de Sherbrooke
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Hôpital de l'Enfant-Jésus
City
Quebec
Country
Canada
Facility Name
Sancheti Institute
City
Prune
Country
India
Facility Name
Ulleval University Hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
33986214
Citation
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.
Results Reference
derived
PubMed Identifier
33105456
Citation
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.
Results Reference
derived
PubMed Identifier
30579406
Citation
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.
Results Reference
derived
PubMed Identifier
29678204
Citation
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.
Results Reference
derived
PubMed Identifier
29608532
Citation
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.
Results Reference
derived
PubMed Identifier
26448371
Citation
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.
Results Reference
derived
PubMed Identifier
20459600
Citation
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.
Results Reference
derived

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Fluid Lavage of Open Wounds

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