Project 170570
FLUID LAVAGE OF OPEN WOUNDS (F.L.O.W.): A Multi-center, Blinded, Factorial Trial Comparing Alternative Irrigating Solutions and Pressures in Patients with Open Fractures
FLUID LAVAGE OF OPEN WOUNDS (F.L.O.W.): A Multi-center, Blinded, Factorial Trial Comparing Alternative Irrigating Solutions and Pressures in Patients with Open Fractures
Project Information
| Study Type: | Trial Randomized_Controlled_Trial |
| Therapeutic Area: | Orthopedics |
| Research Theme: | Clinical |
| Disease Area: | open fractures, trauma |
| Data Type: | Global |
Institution & Funding
| Principal Investigator(s): | Bhandari, Mohit; Guyatt, Gordon H |
| Co-Investigator(s): | Anglen, Jeffrey O; Berry, Gregory K; Bosse, Michael; Broderick, John S; Coles, Chad P; Conflitti, Joseph M; Crist, Brett D; Della Rocca, Gregory J; Guy, Pierre; Iyer, Rajagopalan N; Jeray, Kyle J; Kandemir, Utku; Kreder, Hans J; Laflamme, Georges Y; Miclau, Theodore; O'Brien, Peter J; Papp, Stephen; Petrisor, Brad A; Phieffer, Laura; Prayson, Michael J; Reindl, Rudolf; Russell, George; Sagi, Henry C; Sancheti, Parag K; Schemitsch, Emil H; Sun, Xin; Walter, Stephen D; Zura, Robert D |
| Institution: | McMaster University |
| CIHR Institute: | Population and Public Health |
| Program: | |
| Peer Review Committee: | Randomized Controlled Trials - B (RSB) |
| Competition Year: | 2008 |
| Term: | 4 yrs 0 mth |
Abstract Summary
Traffic accidents ranked among the top 10 causes of global disability in 1990. By 2020, disability from traffic accidents is estimated to rank in the top 3 of all cause disability from disease - second only to ischemic heart disease and depression. The most serious injuries are those fractures that break through the skin. These so called open, or compound, fractures have serious consequences for patients including infections, wound healing problems and failure of fracture healing-many of which necessitate a secondary intervention, or re-operation. For this reason, open fractures are designated as surgical emergencies and require urgent treatment. In North America, an estimated 250,000 open fractures occur annually. The single most important step in the initial management of these complex injuries is a thorough wound irrigation to remove any contaminants. We aim to evaluate whether the type of irrigation solution (soap vs. saline) or irrigation pressure (low vs. high; gravity flow vs. high) will decrease the risk for re-operation among adult patients with open fracture wounds. We secondarily aim to determine the effect of irrigating solution and irrigation pressure on patient function and quality of life. We hypothesize that soap solution may be more effective for reducing risk of infection compared to saline, and that low-pressure and gravity-flow-pressure irrigation will result in fewer re-operations than high-pressure. This trial has the potential for global impact change in resolving the current controversy with irrigation solutions and pressures for care of open fractures.
Research Characteristics
This project includes the following research characteristics:
Study Justification
"evaluate whether the type of irrigation solution (soap vs. saline) or irrigation pressure (low vs. high; gravity flow vs. high) will decrease the risk for re-operation among adult patients with open fracture wounds"
Novelty Statement
"potential for global impact change in resolving the current controversy with irrigation solutions and pressures for care of open fractures"
Methodology Innovation
factorial design comparing different irrigation solutions and pressures in open fracture treatment