N/A
N=111
Fluid Lavage of Open Wounds (FLOW): Pilot Trial
Infection · Wound Healing Problem · Nonunion
Bottom Line
View on ClinicalTrials.gov: NCT01069315 ↗Enrolled (actual)
111
Serious AEs
42.7%
Results posted
Mar 2019
Primary outcome: Primary: The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion). — 7; 6; 3; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Type of fluid lavage solution (Procedure); Type of fluid lavage pressure (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- McMaster University
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion). |
7; 6; 3; 10 | — |
| SECONDARY The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions. |
5; 8; 0; 4; 2; 4 | — |
| 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). |
-1.16; -4.79; -11.60; -12.49 | — |
| 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). |
-0.14; -0.19 | — |
| 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) |
-12.16; -11.94; -4.59; -1.37 | — |
| 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) |
-0.18; -0.15 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01069315). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.