Clinical trial NCT00788398: Fluid Lavage of Open Wounds
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
Overall status: COMPLETED
Phase: NA
Conditions: Open Fracture Wounds
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: McMaster University
name: United States Department of Defense
First posted: 2008-11-10
Enrollment: 2540
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing.
timeFrame: within 12 months
Secondary outcomes:
measure: Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univeristy of Alabama at Birmingham
state: Alabama
city: Orange
country: United States
facility: University of California-Irvine
state: California
city: San Francisco
country: United States
facility: University of California- San Francisco
state: California
city: Indianapolis
country: United States
facility: Wishard Health Services, Indiana University
state: Indiana
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: St. Louis
country: United States
facility: St. Louis University
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Dayton
country: United States
facility: Miami Valley Hospital/Wright State University
state: Ohio
city: Pittsburg
country: United States
facility: University of Pittsburg
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Prahran
country: Australia
facility: The Alfred
city: New Westminster
country: Canada
facility: Royal Columbian Hospital-New Wesminster
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences Winnipeg
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: London
country: Canada
facility: London Health Sciences
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital- Civic
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montreal
country: Canada
facility: Hospital du Sacre-Coeur de Montreal
state: Quebec
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke
state: Quebec
city: Quebec
country: Canada
facility: Hôpital de l'Enfant-Jésus
city: Prune
country: India
facility: Sancheti Institute
city: Oslo
country: Norway
facility: Ulleval University Hospital
Study officials:
affiliation: Greenville Hospital System
name: Kyle J. Jeray, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton Health Sciences Corporation
name: Bradley Petrisor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Mohit Bhandari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Gordan Guyatt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.