Fluid Lavage of Open Wounds

Completed · Not applicable

Conditions studied: Open Fracture Wounds

In brief

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

Key facts

Study ID

NCT00788398

Run by

Prisma Health-Upstate

People needed

2540

Starts

2009-06-01

Expected to finish

2015-04-01

Last updated by the study team

2016-02-11

Who can join

Age: 14 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women who are skeletally mature.
• Fracture of any extremity with complete radiographs.
• Open fractures (Gustilo-Anderson Types I-IIIB) (Table 2)*.
• Fracture requiring operative fixation.
• Provision of informed consent.

You may not qualify if…

• Open fractures with an associated vascular deficit (Gustilo-Anderson Type IIIC).
• Known allergy to detergents or castile soap ingredients.
• Previous wound infection or history of osteomyelitis in the injured extremity.
• Previous fracture with retained hardware in injured extremity that will interfere with new implant fixation.
• Surgical delay to operative wound management greater than 24 hours from hospital admission.
• Use of immunosuppressive medication within 6 months.
• Immunological deficient disease conditions (e.g. HIV).
• Fracture of the hand (metacarpals and phalanges).
• Fracture of the toes (phalanges).
• Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
• Previous randomization in this study or a competing study.

Where it is running

• Univeristy of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California-Irvine — Orange, California, United States
• University of California- San Francisco — San Francisco, California, United States
• Wishard Health Services, Indiana University — Indianapolis, Indiana, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Orthopaedic Associates of Michigan — Grand Rapids, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• University of Missouri Health Care — Columbia, Missouri, United States
• St. Louis University — St Louis, Missouri, United States
• Duke University — Durham, North Carolina, United States
• Miami Valley Hospital/Wright State University — Dayton, Ohio, United States
• University of Pittsburg — Pittsburgh, Pennsylvania, United States
• Greenville Hospital System — Greenville, South Carolina, United States
• Brooke Army Medical Center — Fort Sam Houston, Texas, United States
• The Alfred — Prahran, Australia
• Royal Columbian Hospital-New Wesminster — New Westminster, British Columbia, Canada
• Vancouver General Hospital — Vancouver, British Columbia, Canada
• Health Sciences Winnipeg — Winnipeg, Manitoba, Canada
• Queen Elizabeth II Health Sciences Center — Halifax, Nova Scotia, Canada
• Hamilton Health Sciences — Hamilton, Ontario, Canada
• McMaster University — Hamilton, Ontario, Canada
• London Health Sciences — London, Ontario, Canada
• Ottawa Hospital- Civic — Ottawa, Ontario, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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