Study examines impact of irrigation solutions and pressures; compares pre- and post-injury status
A study presented at the 2016 Orthopaedic Trauma Association (OTA) annual meeting found that patients who had undergone surgical treatment for open fractures had not yet returned to their pre-injury health-related quality of life (HRQL) at 1 year follow-up. Additionally, HRQL scores were similar regardless of the irrigation solution or irrigation pressure used.
The study was based on data from the Fluid Lavage in Open Fracture Wounds (FLOW) trial. Conducted at 41 clinical centers, the FLOW trial evaluated the effect of irrigation solution (soap or normal saline) and irrigation pressures (high, low, or very low) in patients with surgically managed open fractures, explained Kyle J. Jeray, MD.
"FLOW's primary analysis revealed that soap resulted in significantly higher reoperation rates than saline in the first year, and that reoperation rates were similar for all irrigation pressures. As a secondary analysis, we sought to determine the impact of irrigation solution and irrigation pressure on HRQL, as well as to ascertain whether patients' HRQL returns to pre-injury levels at 1 year," said Dr. Jeray.
The 2,447 patients enrolled in the FLOW trial were asked to estimate their pre-injury (baseline) Short Form-12 Physical Component Score (SF-12 PCS), SF-12 Mental Component Score (MCS), and the EuroQol-5 Dimensions (EQ-5D) questionnaires. These questionnaires were then repeated at 2 and 6 weeks, and 3, 6, 9, and 12 months after fracture treatment. The researchers based their analyses on data from the 1,860 patients for whom the SF-12 PCS and SF-12 MCS or the EQ-5D score could be calculated for at least one visit.
Demographics of the 1,860 study patients were similar to those in the larger FLOW cohort. Patients were predominantly male (68 percent) with a mean age of 45 years. Most (70 percent) had sustained lower extremity fractures, and most (52 percent) had been treated with plate fixation.
The researchers used multilevel generalized linear models, each consisting of three levels—clinical site, patient, and time of follow-up—to assess HRQL scores by treatment group. Independent variables included the following:
- randomized solution group
- randomized pressure group
- time of HRQL assessment
- baseline score
- fracture type (Gustilo type I/II versus type III)
- interaction of treatment with time of HRQL assessment
- interaction of fracture type with time of HRQL assessment
The researchers also adjusted their analyses to account for age, upper versus lower extremity injury, postoperative fracture gap, initial method of internal fixation, and severity of wound contamination.
No differences in outcome scores
No clinically significant differences in SF-12 PCS, SF-12 MCS, or EQ-5D utility scores were found between the irrigation solution or irrigation pressure groups at 1-year follow-up. In addition, statistical analysis showed that patient HRQL had not returned to pre-injury levels by 1 year for any of the three outcome measures (P < 0.001), and that patients with lower extremity injuries and Gustilo Type III injuries are at increased risk of reduced HRQL at 1 year.
"Although FLOW's primary analysis revealed that soap was associated with significantly higher reoperation rates than saline [14.8 percent versus 11.6 percent, respectively; P = 0.01], we found no difference in HRQL scores between the soap and saline treatment groups," said Dr. Jeray. "It may be because we didn't use the most appropriate outcome score—generic measures may not be sensitive enough to capture smaller differences in clinically important outcomes. It may also be that the original injury is really what dictates ultimate HRQL outcome at 12 months, regardless of additional surgeries in between."
According to Dr. Jeray, the study's findings may be useful in counseling patients with open fractures on what to expect following surgery. In addition, the fact that patients had not regained pre-injury HRQL at 12 months underscores the need for additional strategies for managing these patients. "Instead of focusing on the physical component—getting the bone and skin to heal—to improve HRQL in these patients, perhaps we should also focus on nonsurgical interventions such as cognitive and behavioral therapy," he said.
Dr. Jeray's coauthors of "Health-related Quality of Life in Patients with Open Fractures" are Sheila Sprague, PhD; Brad Petrisor, MD; Paula McKay; Diane Hells-Ansdell, MSc; Emil Schemitsch, MD; Susan Liew, MD; Gordon Guyatt, MD; Stephen D. Walter, PhD; and Mohit Bhandari, MD, on behalf of the FLOW investigators.
The authors' disclosure information can be accessed at www.aaos.org/disclosure
Maureen Leahy is the assistant managing editor of AAOS Now. She can be reached at email@example.com
- Little data exist about HRQL following surgical management of open fractures.
- This study, based on data from the FLOW trial, evaluated the impact of irrigation solutions and irrigation pressures on patient-reported HRQL in patients with surgically managed open fractures.
- Researchers found no differences in HRQL scores at 1 year, regardless of the solution or pressure used in treatment.
- They also found that patients with open fractures do not return to their pre-injury HRQL status by 12 months postfracture.