Infection, Nonunion, Wound Healing Problem
Conditions
Keywords
open wound, solution, pressure, randomized
Brief summary
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
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.
Interventions
PROCEDUREType of fluid lavage solution
Comparison of castile soap solution vs. normal saline solution.
PROCEDUREType of fluid lavage pressure
Comparison of low pressure vs. high pressure.
Sponsors
The Physicians' Services Incorporated Foundation
Orthopaedic Trauma Association
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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). | 1 year | 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. |
| 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). | one year | 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. |
| 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) | one year | 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. |
| 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) | one year | 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. |
Countries
Canada, India, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normal Saline and High Pressure Irrigation with normal saline delivered at high pressure
Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution.
Type of fluid lavage pressure: Comparison of low pressure vs. high pressure. | 27 |
| Soap Solution and High Pressure Irrigation with soap solution delivered at high pressure
Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution.
Type of fluid lavage pressure: Comparison of low pressure vs. high pressure. | 30 |
| Normal Saline and Low Pressure Irrigation with saline solution delivered at low pressure
Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution.
Type of fluid lavage pressure: Comparison of low pressure vs. high pressure. | 28 |
| Soap Solution and Low Pressure Irrigation with soap solution delivered at low pressure
Type of fluid lavage solution: Comparison of castile soap solution vs. normal saline solution.
Type of fluid lavage pressure: Comparison of low pressure vs. high pressure. | 26 |
| Total | 111 |
Baseline characteristics
| Characteristic | Normal Saline and High Pressure | Soap Solution and High Pressure | Normal Saline and Low Pressure | Soap Solution and Low Pressure | Total |
|---|---|---|---|---|---|
| Age, Continuous | 45.0 years STANDARD_DEVIATION 12.2 | 39.7 years STANDARD_DEVIATION 17.5 | 40.8 years STANDARD_DEVIATION 17.8 | 45.3 years STANDARD_DEVIATION 18.2 | 42.5 years STANDARD_DEVIATION 16.6 |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 9 Participants | 11 Participants | 29 Participants |
| Sex: Female, Male Male | 25 Participants | 23 Participants | 19 Participants | 15 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 27 | 8 / 30 | 0 / 26 | 6 / 27 |
| serious Total, serious adverse events | 13 / 27 | 14 / 30 | 9 / 26 | 11 / 27 |
Outcome results
Primary
The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion).
Time frame: one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Soap, Low Pressure | The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion). | 7 Participants |
| Soap, High Pressure | The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion). | 6 Participants |
| Saline, Low Pressure | The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion). | 3 Participants |
| Saline, High Pressure | The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion). | 10 Participants |
Secondary
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.
Time frame: one year
Population: Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Soap, Low Pressure | 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) | -0.18 units on a scale | Standard Deviation 0.033 |
| Soap, High Pressure | 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) | -0.15 units on a scale | Standard Deviation 0.033 |
Secondary
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.
Time frame: one year
Population: Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Soap, Low Pressure | 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). | -0.14 units on a scale | Standard Deviation 0.33 |
| Soap, High Pressure | 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). | -0.19 units on a scale | Standard Deviation 0.33 |
Secondary
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.
Time frame: one year
Population: Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Soap, Low Pressure | 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) | Physical component summary (PCS) | -4.59 units on a scale | Standard Deviation 1.97 |
| Soap, Low Pressure | 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) | Mental component summary (MCS) | -12.16 units on a scale | Standard Deviation 1.84 |
| Soap, High Pressure | 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) | Mental component summary (MCS) | -11.94 units on a scale | Standard Deviation 1.95 |
| Soap, High Pressure | 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) | Physical component summary (PCS) | -1.37 units on a scale | Standard Deviation 2.28 |
Secondary
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.
Time frame: 1 year
Population: Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Soap, Low Pressure | 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). | Mental component summary (MCS) | -1.16 units on a scale | Standard Deviation 1.5 |
| Soap, Low Pressure | 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). | Physical component summary (PCS) | -11.60 units on a scale | Standard Deviation 1.32 |
| Soap, High Pressure | 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). | Mental component summary (MCS) | -4.79 units on a scale | Standard Deviation 2.3 |
| Soap, High Pressure | 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). | Physical component summary (PCS) | -12.49 units on a scale | Standard Deviation 1.84 |
Secondary
The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions.
Time frame: 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Soap, Low Pressure | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | Infections treated operatively or nonoperatively | 5 Participants |
| Soap, Low Pressure | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | Nonunion treated operatively or nonoperatively | 2 Participants |
| Soap, Low Pressure | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | Wound healing problem treated operatively or nonop | 5 Participants |
| Soap, Low Pressure | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | No infection, nonunion, or wound healing problems | 14 Participants |
| Soap, High Pressure | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | Nonunion treated operatively or nonoperatively | 4 Participants |
| Soap, High Pressure | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | Wound healing problem treated operatively or nonop | 5 Participants |
| Soap, High Pressure | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | No infection, nonunion, or wound healing problems | 13 Participants |
| Soap, High Pressure | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | Infections treated operatively or nonoperatively | 8 Participants |
| Saline, Low Pressure | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | Wound healing problem treated operatively or nonop | 1 Participants |
| Saline, Low Pressure | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | Nonunion treated operatively or nonoperatively | 5 Participants |
| Saline, Low Pressure | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | No infection, nonunion, or wound healing problems | 22 Participants |
| Saline, Low Pressure | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | Infections treated operatively or nonoperatively | 0 Participants |
| Saline, High Pressure | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | No infection, nonunion, or wound healing problems | 6 Participants |
| Saline, High Pressure | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | Nonunion treated operatively or nonoperatively | 8 Participants |
| Saline, High Pressure | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | Infections treated operatively or nonoperatively | 4 Participants |
| Saline, High Pressure | The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. | Wound healing problem treated operatively or nonop | 9 Participants |