title: 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.
abstract: BACKGROUND
  Open fractures frequently result in serious complications for patients, including infections, wound healing problems, and failure of fracture healing, many of which necessitate subsequent operations. One of the most important steps in the initial management of open fractures is a thorough wound irrigation and debridement to remove any contaminants. There is, however, currently no consensus regarding the optimal approach to irrigating open fracture wounds during the initial operative procedure. The selection of both the type of irrigating fluid and the pressure of fluid delivery remain controversial. The primary objective of this study is to investigate the effects of irrigation solutions (soap vs. normal saline) and pressure (low vs. high; gravity flow vs. high; low vs. gravity flow) on re-operation within one year among patients with open fractures.
  
  
  METHODS
  The FLOW study is a multi-center, randomized controlled trial using a 2 x 3 factorial design. Surgeons at clinical sites in North America, Europe, Australia, and Asia will recruit 2 280 patients who will be centrally randomized into one of the 6 treatment arms (soap + low pressure; soap + gravity flow pressure; soap + high pressure; saline + low pressure; saline + gravity flow pressure; saline + high pressure). The primary outcome of the study is re-operation to promote wound or bone healing, or to treat an infection. This composite endpoint of re-operation includes a narrow spectrum of patient-important procedures: irrigation and debridement for infected wound, revision and closure for wound dehiscence, wound coverage procedures for infected or necrotic wound, bone grafts or implant exchange procedures for established nonunion in patients with postoperative fracture gaps less than 1 cm, intramedullary nail dynamizations in the operating room, and fasciotomies for compartment syndrome. Patients, outcome adjudicators, and data analysts will be blinded. We will compare rates of re-operation at 12 months across soap vs. saline, low pressure vs. high pressure, gravity flow pressure vs. high pressure, and low pressure vs. gravity flow pressure. We will measure function and quality of life with the Short Form-12 (SF-12) and the EuroQol-5 Dimensions (EQ-5D) at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months after initial surgical management, and measure patients' illness beliefs with the Somatic Pre-Occupation and Coping (SPOC) questionnaire at 1 and 6 weeks. We will also compare non-operatively managed infections, wound healing, and fracture healing problems at 12 months after initial surgery.
  
  
  CONCLUSIONS
  This study represents a major international effort to identify a simple and easily applicable strategy for emergency wound management. The importance of the question and the potential to identify a low cost treatment strategy argues strongly for global participation, especially in low and middle income countries such as India and China where disability from traumatic injuries is substantial.
  
  
  BACKGROUND
  This trial is registered at ClinicalTrials.gov (NCT00788398).
authors.affiliation: McMaster University, 293 Wellington Street North, Suite 110, Hamilton, Ontario L8L 8E7, Canada. bhandam@mcmaster.ca
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards; D003646:Debridement / Q000379:methods; D003666:Decontamination / Q000379:methods*; D004632:Emergency Medical Services / Q000379:methods / Q000592:standards; D023381:Endpoint Determination; D005597:Fractures, Open / Q000382:microbiology / Q000473:pathology / Q000601:surgery*; D006801:Humans; D011300:Preoperative Care / Q000379:methods* / Q000592:standards; D011312:Pressure; D012107:Research Design; D016037:Single-Blind Method; D012915:Soaps / Q000627:therapeutic use; D012965:Sodium Chloride / Q000627:therapeutic use; D012996:Solutions / Q000737:chemistry / Q000627:therapeutic use; D007507:Therapeutic Irrigation / Q000379:methods*; D014945:Wound Healing / Q000502:physiology; D014946:Wound Infection / Q000517:prevention & control*
chemical_list: D012915:Soaps; D012996:Solutions; D012965:Sodium Chloride
references.citation: Med Care. 1996 Mar;34(3):220-33
references.pmid: 8628042
references.citation: J Orthop Trauma. 2002 Mar;16(3):162-5
references.pmid: 11880778
references.citation: J Orthop Trauma. 1998 Sep-Oct;12(7):460-3
references.pmid: 9781768
references.citation: J Orthop Res. 2002 Nov;20(6):1205-9
references.pmid: 12472230
references.citation: Ostomy Wound Manage. 2007 Apr;53(4):64-6, 68-70, 72
references.pmid: 17449917
references.citation: Acta Orthop. 2006 Apr;77(2):279-84
references.pmid: 16752291
references.citation: J Orthop Trauma. 1999 Jun-Jul;13(5):332-7
references.pmid: 10406699
references.citation: J Bone Joint Surg Am. 1990 Feb;72(2):299-304
references.pmid: 2406275
references.citation: J Orthop Trauma. 1997 Feb-Mar;11(2):121-5
references.pmid: 9057148
references.citation: J Trauma. 2002 Oct;53(4):725-32
references.pmid: 12394874
references.citation: Qual Life Res. 2000;9(6):591-601
references.pmid: 11236850
references.citation: Psychol Bull. 1992 Jul;112(1):155-9
references.pmid: 19565683
references.citation: J Am Acad Orthop Surg. 2001 Sep-Oct;9(5):289-96
references.pmid: 11575908
references.citation: J Bone Joint Surg Am. 2008 Dec;90(12):2567-78
references.pmid: 19047701
references.citation: BMC Med Res Methodol. 2003 Nov 24;3:26
references.pmid: 14633287
references.citation: J Orthop Trauma. 2000 Jan;14(1):2-9
references.pmid: 10630795
references.citation: JAMA. 2003 May 21;289(19):2545-53
references.pmid: 12759326
references.citation: J Orthop Res. 1996 Mar;14(2):251-4
references.pmid: 8648503
references.citation: J Bone Joint Surg Am. 2001 Mar;83(3):412-9
references.pmid: 11263646
references.citation: Clin Orthop Relat Res. 1998 Jan;(346):255-61
references.pmid: 9577434
references.citation: J Orthop Trauma. 2006 Nov-Dec;20(10):692-8
references.pmid: 17106380
references.citation: Int Orthop. 2003;27(1):40-6
references.pmid: 12582808
references.citation: Anesth Analg. 1990 Oct;71(4):430-3
references.pmid: 2400122
references.citation: Clin Orthop Relat Res. 2005 Oct;439:27-31
references.pmid: 16205133
references.citation: J Orthop Trauma. 2002 Aug;16(7):484-90
references.pmid: 12172278
references.citation: Am J Orthop (Belle Mead NJ). 1999 Mar;28(3):156-60
references.pmid: 10195838
references.citation: Int J Surg Investig. 2000;2(3):179-82
references.pmid: 12678517
references.citation: Mil Med. 1971 Mar;136(3):264-6
references.pmid: 5005405
references.citation: Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80
references.pmid: 10219875
references.citation: Ann Surg. 1978 Feb;187(2):170-3
references.pmid: 343735
references.citation: BMC Musculoskelet Disord. 2008 Jun 23;9:91
references.pmid: 18573205
references.citation: J Orthop Trauma. 2002 Jul;16(6):413-7
references.pmid: 12142830
references.citation: BMC Musculoskelet Disord. 2008 Jan 23;9:7
references.pmid: 18215287
references.citation: Ann Med. 2001 Jul;33(5):344-9
references.pmid: 11491193
references.citation: J Orthop Trauma. 1999 Nov;13(8):526-33
references.pmid: 10714777
references.citation: J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):219-26
references.pmid: 11476531
references.citation: J Orthop Trauma. 1998 Sep-Oct;12(7):479-84
references.pmid: 9781772
references.citation: J Bone Joint Surg Am. 2005 Jul;87(7):1415-22
references.pmid: 15995106
references.citation: BMJ. 2005 Jan 8;330(7482):88
references.pmid: 15637373
references.citation: J Orthop Trauma. 1994 Oct;8(5):390-6
references.pmid: 7996321
references.citation: Clin Orthop Relat Res. 1996 Aug;(329):255-62
references.pmid: 8769460
references.citation: J Orthop Trauma. 1995;9(4):303-11
references.pmid: 7562152