Fluid Lavage of Open Wounds
| Status: | Completed |
|---|---|
| Healthy: | No |
| Age Range: | 14 - 85 |
| Updated: | 4/21/2016 |
| Start Date: | June 2009 |
| End Date: | April 2015 |
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
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
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.
We found this trial at
15
sites
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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