We will compare rates of re-operation at 12 months across soap vs. Patients, outcome adjudicators, and data analysts will be blinded. 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. The primary outcome of the study is re-operation to promote wound or bone healing, or to treat an infection. 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).
Pulsa vac trial#
The FLOW study is a multi-center, randomized controlled trial using a 2 × 3 factorial design. gravity flow) on re-operation within one year among patients with open fractures. The primary objective of this study is to investigate the effects of irrigation solutions (soap vs. The selection of both the type of irrigating fluid and the pressure of fluid delivery remain controversial. There is, however, currently no consensus regarding the optimal approach to irrigating open fracture wounds during the initial operative procedure. One of the most important steps in the initial management of open fractures is a thorough wound irrigation and debridement to remove any contaminants. 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.