Fluid Lavage of Open Wounds

Study Overview
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Brief Summary
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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

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

Conditions
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Open Fracture Wounds

Intervention / Treatment
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* Procedure: Saline Solution
* Procedure: Soap solution
* Procedure: Gravity Flow Irrigation
* Procedure: Low Pressure Irrigation
* Procedure: High Pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Saline, gravity flow<br> | Procedure: Saline Solution<br>* Irrigation with Saline<br>Procedure: Gravity Flow Irrigation<br>* 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.<br>|
| Active Comparator: Saline, Low Pressure<br> | Procedure: Saline Solution<br>* Irrigation with Saline<br>Procedure: Low Pressure Irrigation<br>* 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.<br>|
| Active Comparator: Saline, High Pressure<br> | Procedure: Saline Solution<br>* Irrigation with Saline<br>Procedure: High Pressure<br>* 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.<br>|
| Active Comparator: Soap, Gravity Flow<br> | Procedure: Soap solution<br>* Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)<br>Procedure: Gravity Flow Irrigation<br>* 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.<br>|
| Active Comparator: Soap, low pressure<br> | Procedure: Soap solution<br>* Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)<br>Procedure: Low Pressure Irrigation<br>* 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.<br>|
| Active Comparator: Soap, high pressure<br> | Procedure: Soap solution<br>* Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)<br>Procedure: High Pressure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing. |  | within 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D |  | 12 months |