title: A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds.
abstract: BACKGROUND
  The management of open fractures requires wound irrigation and débridement to remove contaminants, but the effectiveness of various pressures and solutions for irrigation remains controversial. We investigated the effects of castile soap versus normal saline irrigation delivered by means of high, low, or very low irrigation pressure.
  
  
  METHODS
  In this study with a 2-by-3 factorial design, conducted at 41 clinical centers, we randomly assigned patients who had an open fracture of an extremity to undergo irrigation with one of three irrigation pressures (high pressure [>20 psi], low pressure [5 to 10 psi], or very low pressure [1 to 2 psi]) and one of two irrigation solutions (castile soap or normal saline). The primary end point was reoperation within 12 months after the index surgery for promotion of wound or bone healing or treatment of a wound infection.
  
  
  RESULTS
  A total of 2551 patients underwent randomization, of whom 2447 were deemed eligible and included in the final analyses. Reoperation occurred in 109 of 826 patients (13.2%) in the high-pressure group, 103 of 809 (12.7%) in the low-pressure group, and 111 of 812 (13.7%) in the very-low-pressure group. Hazard ratios for the three pairwise comparisons were as follows: for low versus high pressure, 0.92 (95% confidence interval [CI], 0.70 to 1.20; P=0.53), for high versus very low pressure, 1.02 (95% CI, 0.78 to 1.33; P=0.89), and for low versus very low pressure, 0.93 (95% CI, 0.71 to 1.23; P=0.62). Reoperation occurred in 182 of 1229 patients (14.8%) in the soap group and in 141 of 1218 (11.6%) in the saline group (hazard ratio, 1.32, 95% CI, 1.06 to 1.66; P=0.01).
  
  
  CONCLUSIONS
  The rates of reoperation were similar regardless of irrigation pressure, a finding that indicates that very low pressure is an acceptable, low-cost alternative for the irrigation of open fractures. The reoperation rate was higher in the soap group than in the saline group. (Funded by the Canadian Institutes of Health Research and others; FLOW ClinicalTrials.gov number, NCT00788398.).
authors.forename: Mohit
authors.initials: M
authors.lastname: Bhandari
authors.forename: Kyle J
authors.initials: KJ
authors.lastname: Jeray
authors.forename: Brad A
authors.initials: BA
authors.lastname: Petrisor
authors.forename: P J
authors.initials: PJ
authors.lastname: Devereaux
authors.forename: Diane
authors.initials: D
authors.lastname: Heels-Ansdell
authors.forename: Emil H
authors.initials: EH
authors.lastname: Schemitsch
authors.forename: Jeff
authors.initials: J
authors.lastname: Anglen
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Della Rocca
authors.forename: Clifford
authors.initials: C
authors.lastname: Jones
authors.forename: Hans
authors.initials: H
authors.lastname: Kreder
authors.forename: Susan
authors.initials: S
authors.lastname: Liew
authors.forename: Paula
authors.initials: P
authors.lastname: McKay
authors.forename: Steven
authors.initials: S
authors.lastname: Papp
authors.forename: Parag
authors.initials: P
authors.lastname: Sancheti
authors.forename: Sheila
authors.initials: S
authors.lastname: Sprague
authors.forename: Trevor B
authors.initials: TB
authors.lastname: Stone
authors.forename: Xin
authors.initials: X
authors.lastname: Sun
authors.forename: Stephanie L
authors.initials: SL
authors.lastname: Tanner
authors.forename: Paul
authors.initials: P
authors.lastname: Tornetta
authors.forename: Ted
authors.initials: T
authors.lastname: Tufescu
authors.forename: Stephen
authors.initials: S
authors.lastname: Walter
authors.forename: Gordon H
authors.initials: GH
authors.lastname: Guyatt
mesh_terms: D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D005597:Fractures, Open / Q000601:surgery / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011312:Pressure; D012086:Reoperation; D016037:Single-Blind Method; D012915:Soaps / Q000627:therapeutic use*; D012965:Sodium Chloride / Q000627:therapeutic use*; D007507:Therapeutic Irrigation / Q000379:methods*; D014945:Wound Healing; D014946:Wound Infection / Q000517:prevention & control / Q000601:surgery
chemical_list: D012915:Soaps; D012965:Sodium Chloride