Open Fracture Wounds Clinical Trial
— FLOWOfficial title:
Fluid Lavage of Open Wounds (FLOW): A Multi-center, Blinded, Factorial Trial Comparing Alternative Irrigating Solutions and Pressures in Patients With Open Fractures
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
| Status | Completed |
| Enrollment | 2540 |
| Est. completion date | April 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 14 Years to 85 Years |
| Eligibility |
Inclusion Criteria: 1. Men or women who are skeletally mature. 2. Fracture of any extremity with complete radiographs. 3. Open fractures (Gustilo-Anderson Types I-IIIB) (Table 2)*. 4. Fracture requiring operative fixation. 5. Provision of informed consent. Exclusion Criteria: 1. Open fractures with an associated vascular deficit (Gustilo-Anderson Type IIIC). 2. Known allergy to detergents or castile soap ingredients. 3. Previous wound infection or history of osteomyelitis in the injured extremity. 4. Previous fracture with retained hardware in injured extremity that will interfere with new implant fixation. 5. Surgical delay to operative wound management greater than 24 hours from hospital admission. 6. Use of immunosuppressive medication within 6 months. 7. Immunological deficient disease conditions (e.g. HIV). 8. Fracture of the hand (metacarpals and phalanges). 9. Fracture of the toes (phalanges). 10. 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. 11. Previous randomization in this study or a competing study. |
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | The Alfred | Prahran | |
| 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 | Hospital du Sacre-Coeur de Montreal | Montreal | Quebec |
| Canada | McGill University Health Centre | Montreal | Quebec |
| Canada | Royal Columbian Hospital-New Wesminster | New Westminster | British Columbia |
| Canada | Ottawa Hospital- Civic | Ottawa | Ontario |
| Canada | Hôpital de l'Enfant-Jésus | Quebec | |
| Canada | Université de Sherbrooke | Sherbrooke | Quebec |
| Canada | St. Michael's Hospital | Toronto | Ontario |
| Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
| Canada | Vancouver General Hospital | Vancouver | British Columbia |
| Canada | Health Sciences Winnipeg | Winnipeg | Manitoba |
| India | Sancheti Institute | Prune | |
| Norway | Ulleval University Hospital | Oslo | |
| United States | Univeristy of Alabama at Birmingham | Birmingham | Alabama |
| United States | Lahey Clinic | Burlington | Massachusetts |
| United States | University of Missouri Health Care | Columbia | Missouri |
| United States | Miami Valley Hospital/Wright State University | Dayton | Ohio |
| United States | Duke University | Durham | North Carolina |
| United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
| United States | Orthopaedic Associates of Michigan | Grand Rapids | Michigan |
| United States | Greenville Hospital System | Greenville | South Carolina |
| United States | Wishard Health Services, Indiana University | Indianapolis | Indiana |
| United States | Hennepin County Medical Center | Minneapolis | Minnesota |
| United States | University of California-Irvine | Orange | California |
| United States | University of Pittsburg | Pittsburg | Pennsylvania |
| United States | University of California- San Francisco | San Francisco | California |
| United States | St. Louis University | St. Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Greenville Health System | McMaster University, United States Department of Defense |
United States, Australia, Canada, India, Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing. | within 12 months | No | |
| Secondary | Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D | 12 months | No |