Trial Outcomes & Findings for Fluid Lavage of Open Wounds (FLOW): Pilot Trial (NCT NCT01069315)
NCT ID: NCT01069315
Last Updated: 2019-03-18
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
111 participants
Primary outcome timeframe
one year
Results posted on
2019-03-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
30
|
28
|
26
|
|
Overall Study
COMPLETED
|
23
|
24
|
23
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
5
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fluid Lavage of Open Wounds (FLOW): Pilot Trial
Baseline characteristics by cohort
| Measure |
Normal Saline and High Pressure
n=27 Participants
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.
|
Soap Solution and High Pressure
n=30 Participants
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.
|
Normal Saline and Low Pressure
n=28 Participants
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.
|
Soap Solution and Low Pressure
n=26 Participants
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.
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.0 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 17.5 • n=7 Participants
|
40.8 years
STANDARD_DEVIATION 17.8 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 18.2 • n=4 Participants
|
42.5 years
STANDARD_DEVIATION 16.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: one yearOutcome measures
| Measure |
Soap, Low Pressure
n=26 Participants
|
Soap, High Pressure
n=30 Participants
|
Saline, Low Pressure
n=28 Participants
|
Saline, High Pressure
n=27 Participants
|
|---|---|---|---|---|
|
The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion).
|
7 Participants
|
6 Participants
|
3 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Soap, Low Pressure
n=26 Participants
|
Soap, High Pressure
n=30 Participants
|
Saline, Low Pressure
n=28 Participants
|
Saline, High Pressure
n=27 Participants
|
|---|---|---|---|---|
|
The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions.
Infections treated operatively or nonoperatively
|
5 Participants
|
8 Participants
|
0 Participants
|
4 Participants
|
|
The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions.
Nonunion treated operatively or nonoperatively
|
2 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
|
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
|
5 Participants
|
1 Participants
|
9 Participants
|
|
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
|
13 Participants
|
22 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.
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.
Outcome measures
| Measure |
Soap, Low Pressure
n=37 Participants
|
Soap, High Pressure
n=38 Participants
|
Saline, Low Pressure
|
Saline, 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)
|
-1.16 units on a scale
Standard Deviation 1.50
|
-4.79 units on a scale
Standard Deviation 2.30
|
—
|
—
|
|
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
|
-12.49 units on a scale
Standard Deviation 1.84
|
—
|
—
|
SECONDARY outcome
Timeframe: one yearPopulation: Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.
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.
Outcome measures
| Measure |
Soap, Low Pressure
n=36 Participants
|
Soap, High Pressure
n=39 Participants
|
Saline, Low Pressure
|
Saline, 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).
|
-0.14 units on a scale
Standard Deviation 0.33
|
-0.19 units on a scale
Standard Deviation 0.33
|
—
|
—
|
SECONDARY outcome
Timeframe: one yearPopulation: Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.
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.
Outcome measures
| Measure |
Soap, Low Pressure
n=38 Participants
|
Soap, High Pressure
n=37 Participants
|
Saline, Low Pressure
|
Saline, 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)
|
-12.16 units on a scale
Standard Deviation 1.84
|
-11.94 units on a scale
Standard Deviation 1.95
|
—
|
—
|
|
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
|
-1.37 units on a scale
Standard Deviation 2.28
|
—
|
—
|
SECONDARY outcome
Timeframe: one yearPopulation: Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.
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.
Outcome measures
| Measure |
Soap, Low Pressure
n=40 Participants
|
Soap, High Pressure
n=35 Participants
|
Saline, Low Pressure
|
Saline, 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)
|
-0.18 units on a scale
Standard Deviation 0.033
|
-0.15 units on a scale
Standard Deviation 0.033
|
—
|
—
|
Adverse Events
Soap, Low Pressure
Serious events: 13 serious events
Other events: 4 other events
Deaths: 0 deaths
Soap, High Pressure
Serious events: 14 serious events
Other events: 8 other events
Deaths: 0 deaths
Saline, Low Pressure
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline, High Pressure
Serious events: 11 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Soap, Low Pressure
n=27 participants at risk
|
Soap, High Pressure
n=30 participants at risk
|
Saline, Low Pressure
n=26 participants at risk
|
Saline, High Pressure
n=27 participants at risk
|
|---|---|---|---|---|
|
Surgical and medical procedures
All SAEs
|
48.1%
13/27 • Number of events 25 • 12 months
Adverse Events were monitored/ assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
46.7%
14/30 • Number of events 26 • 12 months
Adverse Events were monitored/ assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
34.6%
9/26 • Number of events 15 • 12 months
Adverse Events were monitored/ assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
40.7%
11/27 • Number of events 31 • 12 months
Adverse Events were monitored/ assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
Other adverse events
| Measure |
Soap, Low Pressure
n=27 participants at risk
|
Soap, High Pressure
n=30 participants at risk
|
Saline, Low Pressure
n=26 participants at risk
|
Saline, High Pressure
n=27 participants at risk
|
|---|---|---|---|---|
|
Surgical and medical procedures
All other AEs
|
14.8%
4/27 • Number of events 4 • 12 months
Adverse Events were monitored/ assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
26.7%
8/30 • Number of events 12 • 12 months
Adverse Events were monitored/ assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
0.00%
0/26 • 12 months
Adverse Events were monitored/ assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
22.2%
6/27 • Number of events 6 • 12 months
Adverse Events were monitored/ assessed in such a manner that the specific Adverse Event Terms cannot be separated
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place