Fluid Lavage of Open Wounds (FLOW): Pilot Trial

Study Overview
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Brief Summary
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The purpose of this trial is to investigate whether irrigation solution (soap vs. saline solution), or irrigation pressure (high vs. low) will decrease the rate of infection among patients with open fracture wounds.

Detailed Description
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Open fractures are an important source of morbidity and are associated with delayed union, nonunion, and infection. Preventing infection through meticulous irrigation and debridement is an important goal in management, and different lavage fluids and irrigation techniques (e.g. high or low pressure lavage) have been described for this purpose. There are, however, a limited number of randomized trials comparing irrigating solutions or irrigating technique. We compared the use of castile soap versus normal saline, as well as high versus low pressure pulsatile lavage on the rates of reoperations and complications in patients with open fracture wounds.

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

Conditions
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Infection, Wound Healing Problem, Nonunion

Intervention / Treatment
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* Procedure: Type of fluid lavage solution
* Procedure: Type of fluid lavage pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: skeletally mature sustained an open fracture of the appendicular skeleton (type I to IIIb). Exclusion Criteria: vascular deficit [any] allergy to detergents or castile soap previous wound infection or osteomyelitis previous fracture with retained hardware in the injured extremity operative management more than 24 hours after injury use of immunosuppressive medication within six months immunological deficiency or disease conditions fractures of the hands (distal to the carpus) or toes
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 |
| --- | --- |
| Experimental: Normal saline and High pressure<br>Irrigation with normal saline delivered at high pressure | Procedure: Type of fluid lavage solution<br>* Comparison of castile soap solution vs. normal saline solution.<br>Procedure: Type of fluid lavage pressure<br>* Comparison of low pressure vs. high pressure.<br>|
| Experimental: Soap solution and High pressure<br>Irrigation with soap solution delivered at high pressure | Procedure: Type of fluid lavage solution<br>* Comparison of castile soap solution vs. normal saline solution.<br>Procedure: Type of fluid lavage pressure<br>* Comparison of low pressure vs. high pressure.<br>|
| Experimental: Normal saline and Low pressure<br>Irrigation with saline solution delivered at low pressure | Procedure: Type of fluid lavage solution<br>* Comparison of castile soap solution vs. normal saline solution.<br>Procedure: Type of fluid lavage pressure<br>* Comparison of low pressure vs. high pressure.<br>|
| Experimental: Soap solution and Low pressure<br>Irrigation with soap solution delivered at low pressure | Procedure: Type of fluid lavage solution<br>* Comparison of castile soap solution vs. normal saline solution.<br>Procedure: Type of fluid lavage pressure<br>* Comparison of low pressure vs. high pressure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion). |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. |  | 1 year | 
| Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the SF-12 Questionnaire (Solution). | Solution and pressure were analyzed separately for this outcome. The SF-12 summary scores (PCS-12 and MCS-12) ranges from 0 to 100. Higher scores indicate that a person has better health status, while lower scores indicate poorer health status. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm. | 1 year | 
| Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the EQ-5D Questionnaire (Solution). | Solution and pressure were analyzed separately for this outcome. The EQ-5D summary score ranges from 0 to 1. Higher scores indicate that a person has a better health-related quality of life, while lower scores indicate worse health-related quality of life. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm. | one year | 
| Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the SF-12 Questionnaire (Pressure) | Solution and pressure were analyzed separately for this outcome. The SF-12 summary scores (PCS-12 and MCS-12) ranges from 0 to 100. Higher scores indicate that a person has better health status, while lower scores indicate poorer health status. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm. | one year | 
| Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the EQ-5D Questionnaire (Pressure) | Solution and pressure were analyzed separately for this outcome. The EQ-5D summary score ranges from 0 to 1. Higher scores indicate that a person has a better health-related quality of life, while lower scores indicate worse health-related quality of life. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open wound, solution, pressure, randomized