Study Design
Our study was an international, blinded, randomized,
controlled trial that used a 2-by-3 factorial
design to evaluate the effects of high versus low
versus very low (gravity flow) irrigation pressures
and soap versus normal saline solutions
on reoperation rates among patients with an
open fracture. The objectives and methods of the
trial were published previously.24 The study was
approved by the ethics committees at McMaster
University, Greenville Health System, and each
participating center. All the patients provided
written informed consent