AAOS 2017: Health-related QOL and function deficit remains at 12-month in open fracture pa

Study Type: Randomized Trial
OE Level of Evidence: N/A
Journal Level of Evidence: N/A
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Synopsis
2,447 patients with an open wound fracture were originally included in this randomized 2x3 factorial design trial evaluating the use of different irrigation solutions (soap or saline) and pressures (very low, low, high) on the rate of reoperation and clinical outcomes. This was a secondary analysis of this trial conducted to determine the effect of these interventions on health-related quality-of-life (HR-QoL) and function at a follow-up of 12-months, and to describe the progression of HR-QoL and function of this patient population, in general. The results indicated Please login to view the rest of this report. Please login to view the rest of this report.
Why was this study needed now?
Few trials have provided data on the health-related quality of life and function of patients with open fractures managed operatively, and if outcomes vary by the method of lavage used to clean the wound.
What was the principal research question?
In patients with open fractures who were managed surgically, were there significant differences in health-related quality-of-life and functional outcomes between lavage with soap or saline? Additionally, how did health-related quality-of-life and functional outcomes change over a one-year period?
Population: 2,447 patients with open wound fractures. Patients were included in 2X3 factorial design using varying irrigation solution and irrigation pressures.
Intervention: Soap Irrigation: Patients underwent soap irrigation. Patients were randomized within this group to 1 of three pressures (very low, low, or high)
Comparison: Saline irrigation: Patients underwent saline irrigation. Patients were randomized within this group to 1 of three pressure (very low, low, high)
Outcomes: Health-related quality-of-life (HR-QoL) and functional outcomes were assessed using both mental and physical components of the Short-Form 12-Item Health Survey (MCID = 5pts) and the EuroQol-5 Dimensions (EQ-5D) (MCID = 0.03).
Methods: RCT: 2x3 factorial design
Time: Outcomes were evaluated preoperatively, at 2 and 6 weeks, and at 3, 6, 9, and 12 months.
What were the important findings?
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How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.