NCT00788398

Fluid Lavage of Open Wounds

Fluid Lavage of Open Wounds (FLOW): A Multi-center, Blinded, Factorial Trial Comparing Alternative Irrigating Solutions and Pressures in Patients With Open Fractures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,540 (actual)
• Sponsor: Prisma Health-Upstate · Academic / Other
• Sex: All
• Age: 14 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Open fracture wounds are a constant challenge to orthopaedic surgeons, with infections a common complication. There is currently little evidence as to which is the most effective way to wash out these wounds. This study is a multi-center, prospective, randomized study. The infection rates will be compared between irrigation using high pressure versus low pressure versus gravity flow, and also saline versus a soap solution as the irrigation solution. The results from this study will help to determine the best method of washing out open fractures wounds. In this study, all open wounds will be washed out using methods commonly used by orthopaedic surgeons

Conditions

• Open Fracture Wounds

Interventions

Type	Name	Description
PROCEDURE	Saline Solution	Irrigation with Saline
PROCEDURE	Soap solution	Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)
PROCEDURE	Gravity Flow Irrigation	Gravity flow irrigation will be standardized across participating centers as 3L bags of normal saline (alone or with soap solution) suspended 6-8 feet above floor level using an I.V. pole. Irrigation tubing (measuring 1/4 - 3/8 inch inner diameter) will be connected to the 3L bag and secured with a stopcock (or compressive device) until ready for use.
PROCEDURE	Low Pressure Irrigation	Irrigation with the Stryker SurgiLav System. At the low pressure setting delivers 5.9 p.s.i. pressure. The high-flow irrigator tip will be held perpendicular to and 5cm above the wound. Irrigation with the Zimmer PulsaVac. For low pressure delivery, the shower tip will be used at the low pressure setting which delivers a pressure of 5.8 p.s.i.
PROCEDURE	High Pressure	Irrigation with the Stryker SurgiLav System. For the high pressure delivery, the multi-orifice tip will be used at the high setting which delivers a pressure of 30 p.s.i. Irrigation with the Zimmer PulsaVac System: For the high pressure delivery the shower tip will be used at the high pressure setting which delivers a pressure of 23 p.s.i.

Timeline

• Start date: 2009-06-01
• Primary completion: 2015-01-01
• Completion: 2015-04-01
• First posted: 2008-11-10
• Last updated: 2016-02-11

Locations

31 sites across 5 countries: United States, Australia, Canada, India, Norway