A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds.

BACKGROUND: The management of open fractures requires wound irrigation and débridement to remove contaminants, but the effectiveness of various pressures and solutions for irrigation remains controversial. We investigated the effects of castile soap versus normal saline irrigation delivered by means of high, low, or very low irrigation pressure. METHODS: In this study with a 2-by-3 factorial design, conducted at 41 clinical centers, we randomly assigned patients who had an open fracture of an extremity to undergo irrigation with one of three irrigation pressures (high pressure [>20 psi], low pressure [5 to 10 psi], or very low pressure [1 to 2 psi]) and one of two irrigation solutions (castile soap or normal saline). The primary end point was reoperation within 12 months after the index surgery for promotion of wound or bone healing or treatment of a wound infection. RESULTS: A total of 2551 patients underwent randomization, of whom 2447 were deemed eligible and included in the final analyses. Reoperation occurred in 109 of 826 patients (13.2%) in the high-pressure group, 103 of 809 (12.7%) in the low-pressure group, and 111 of 812 (13.7%) in the very-low-pressure group. Hazard ratios for the three pairwise comparisons were as follows: for low versus high pressure, 0.92 (95% confidence interval [CI], 0.70 to 1.20; P=0.53), for high versus very low pressure, 1.02 (95% CI, 0.78 to 1.33; P=0.89), and for low versus very low pressure, 0.93 (95% CI, 0.71 to 1.23; P=0.62). Reoperation occurred in 182 of 1229 patients (14.8%) in the soap group and in 141 of 1218 (11.6%) in the saline group (hazard ratio, 1.32, 95% CI, 1.06 to 1.66; P=0.01). CONCLUSIONS: The rates of reoperation were similar regardless of irrigation pressure, a finding that indicates that very low pressure is an acceptable, low-cost alternative for the irrigation of open fractures. The reoperation rate was higher in the soap group than in the saline group. (Funded by the Canadian Institutes of Health Research and others; FLOW ClinicalTrials.gov number, NCT00788398.).

Fluid lavage of open wounds (FLOW): a multicenter, blinded, factorial pilot trial comparing alternative irrigating solutions and pressures in patients with open fractures.

BACKGROUND: 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. However, there are a limited number of randomized trials comparing irrigating solutions or irrigating technique. We compared the use of castile soap versus normal saline and high- versus low-pressure pulsatile lavage on the rates of reoperations and complications in patients with open fracture wounds. METHODS: We conducted a multicenter, blinded, randomized 2 × 2 factorial pilot trial of 111 patients in whom an open fracture wound was treated with either castile soap solution or normal saline and either high- or low-pressure pulsatile lavage. The primary composite outcome of reoperation, measured at 12 months after initial operative procedure, included infection, wound healing problems, and nonunion. Planned reoperations were not included. Secondary outcomes included all infection, all wound healing problems, and nonunion as well as functional outcomes scores (EuroQol-5 dimensions and short form-12). RESULTS: Eighty-nine patients completed the 1-year follow-up. Among all patients, 13 (23%) in the castile soap group and 13 (24%) in the saline group had a primary outcome event (hazard ratio, 0.91, 95% confidence interval: 0.42-2.00, p = 0.52). Sixteen patients (28%) in the high-pressure group and 10 patients (19%) in the low-pressure group had a primary outcome event (hazard ratio 0.55, 95% confidence interval: 0.24-1.27, p = 0.17). Functional outcome scores showed no significant differences at any time point between groups. CONCLUSION: The fluid lavage of open wounds pilot randomized controlled trial demonstrated the possibility that the use of low pressure may decrease the reoperation rate for infection, wound healing problems, or nonunion. We have demonstrated the desirability and feasibility of a definitive trial examining the effects of alternative irrigation approaches.

Enhanced fracture and soft-tissue healing by means of anabolic dietary supplementation.

BACKGROUND: Malnutrition is common in hospitalized injured patients. It contributes to delayed fracture-healing and increased morbidity. However, relatively little attention has been directed toward nutritional strategies for augmenting musculoskeletal recovery after a fracture. This animal study was designed to examine the effects of dietary protein intake and the role of conditionally essential amino acids in muscle and bone-healing after a fracture. METHODS: One hundred adult male rats were used. Ten rats served as controls and received a 15% protein diet throughout the study. The remaining ninety rats received a 6% protein diet for five weeks to induce protein malnutrition. The rats underwent intramedullary nailing and closed midshaft fracture of one femur. After the fracture, they were separated into three isocaloric dietary groups. Group P6 received a diet with 6% protein; Group P15, a diet with 15% protein; and group P30, a diet with 30% protein with conditionally essential amino acids. At two, four, and six weeks after surgery, ten animals from each group were killed and the femora were evaluated with dual x-ray absorptiometry, histomorphometric assessment of callus, and torsional testing. The quadriceps muscles were analyzed for total mass, total protein content, and for mRNA expression of insulin-like growth factor-1 (IGF-1), IGF-2, IGF receptors, actin, myosin, and vascular endothelial growth factor (VEGF). RESULTS: The P30 group demonstrated elevations in albumin, body mass, muscle mass, total protein content of muscle, and bone mineral density in the fracture callus compared with the P6 diet group at six weeks (p < 0.05). Molecular analysis of muscle revealed that IGF-1, IGF-2, IGF receptors, myosin, actin, and VEGF gene expression were significantly (p < 0.001) higher in the P6 group compared with the P30 group. Biomechanical testing of the femora, however, showed no significant differences. CONCLUSIONS: Dietary supplementation with conditionally essential amino acids in malnourished animals had anabolic effects on bone mineralization, body mass, and muscle mass.

Are recent graduates of orthopaedic training programs performing less fracture care? American Board of Orthopedic Surgeons part II: a quality improvement initiative.

OBJECTIVES: The purpose of this study was to evaluate whether there has been a change in the amount of fracture care performed by recent graduates of orthopaedic residency programs over time. DESIGN: Retrospective review. SETTING: American Board of Orthopaedic Surgery (ABOS) Part II database. PARTICIPANTS: Candidates applying for Part II of the second part of the Orthopaedic (ABOS) certification. INTERVENTION: The ABOS Part II database was searched from years 1999 to 2008 for Current Procedural Terminology codes indicating 1) "simpler fractures" that any candidate surgeon should be able to perform; 2) "complex fractures" that are often referred to surgeons with specialty training; and 3) "emergent cases" that should be done emergently by a physician. MAIN OUTCOME MEASURE: Logistic regression and chi-square tests were used to evaluate whether there has been a change in the amount of fracture care among recent graduates of orthopaedic residency programs over time. RESULTS: Over the 10-year period (1999-2008), a total of 95,922 cases were in the simpler fractures category; 16,523 were classified as complex fractures and 17,789 were classified as emergent cases. The overall number of cases by fracture type increased from 1999 to 2008 as did the average number of surgery cases performed by surgeons in each category over the 6-month collection period. Simpler fracture cases increased 18% (8304-9784 cases) with the average number surgically treated by surgeons performing at least one simple fracture case also increasing 18% (14.1-16.6 cases per surgeon). Complex fracture cases increased 51% (1266-1916 cases) with the average number of these cases per surgeon operating at least one complex fracture case increasing 52% (3.3-5.0 cases per surgeon). Emergent fracture cases increased 92% (1178-2264 cases) with the average number of these cases per surgeon operating at least one emergent fracture case increasing 49% (4.5-6.7 cases per surgeon). CONCLUSION: From the data presented here, candidate orthopaedic surgeons are treating fractures as least as often as young surgeons were 10 years ago.

The clinical use of bone stimulators.

Delay or failure of healing in long bone fracture is a common clinical problem confronting the orthopaedic surgeon, and can have significant impact on the quality of life for patients who have it. One treatment option for this problem is the use of electrical or ultrasonic bone stimulation. Electrical signals can be delivered with an implantable direct current stimulator, or noninvasively using inductive or capacitive coupling to induce currents in the tissues. Low-intensity ultrasound can speed the healing of fresh fractures. Although regarded with skepticism by many physicians, there is abundant evidence from clinical studies of the effectiveness of these treatments. In addition to dozens of retrospective reports, randomized, prospective, double-blind controlled trials have shown the efficacy of electrical stimulation for nonunion and ultrasound for speeding healing. Patients with unacceptable deformity, synovial pseudarthrosis, or large gaps are generally not good candidates for this treatment modality. This article is a review of the clinical literature regarding treatment of long bone nonunion with bone stimulators.

Treatment of osteomyelitis with local antibiotics delivered via bioabsorbable polymer.

The purpose of the current study was to show the efficacy and safety of an absorbable polymer (polycaprolactone) as an antibiotic delivery vehicle for treatment of osteomyelitis. An intramedullary osteomyelitis was induced in the femur of adult rabbits by Staphylococcus aureus inoculation after use of a sclerosing agent, and then treatment was done with intramedullary irrigation and implantation of a rod made of polycaprolactone, polycaprolactone plus 6% tobramycin, or polymethylmethacrylate plus 6% tobramycin. A control group received irrigation only. At defined intervals, the animals were euthanized and culture of the inoculated site was done. In addition, histologic sections of body tissues were made to look for signs of systemic toxicity of the implant. After 4 weeks of treatment, a statistically significant difference was found between the animals that were treated with irrigation alone and the animals that were treated with antibiotic-laden rods of polycaprolactone or polymethylmethacrylate. There was no difference between the antibiotic rod types. No histologic evidence of toxicity was found. Bioabsorbable rods of polycaprolactone are a safe and effective means of antibiotic delivery for treatment of osteomyelitis.

Flexion and extension views are not cost-effective in a cervical spine clearance protocol for obtunded trauma patients.

BACKGROUND: Between 1994 and 1999, 837 flexion-extension cervical spine films (F/E) were ordered as part of a protocol to evaluate cervical stability in blunt trauma victims, particularly obtunded patients with otherwise normal films. After 5 years' experience with this protocol, a review of its efficiency and cost-effectiveness was performed. METHOD: The radiology reports and charts were reviewed for positive or suggestive F/E series. RESULTS: Nearly a third of all series were inadequate to rule out instability. Only four patients were identified who had decreased admission Glasgow Coma Scale score, normal plain films and/or CT, and positive or suggestive findings on F/E. One was felt to be a false positive, and the others had minor or borderline findings; all were treated with continuation of the cervical collar. Although one patient was lost to follow-up, none of the other three required subsequent surgery or developed deformity or neurologic injury. CONCLUSION: Flexion-extension studies were not a cost-effective part of the protocol, and they were dropped.

The use of forced flexion/extension views in the obtunded trauma patient.

OBJECTIVE: To determine whether forced flexion/extension (F/E) films for "clearing" the cervical spine in unconscious or semiconscious patients are useful or actually dangerous. DESIGN AND PATIENTS: Of 810 patients admitted for blunt trauma over a 5-year period, 479 patients whose films and charts were available received passive F/E film views of the cervical spine. Of these, 447 were reviewed retrospectively in masked fashion for any exacerbation of neurological changes subsequent to the procedure and with respect to the final neurological status at discharge. RESULTS: Twenty-nine patients (6%) had various abnormalities including fractures and ligamentous injuries seen on the initial films. Following forced F/E films no change was made in the diagnosis of 23 patients. Of the remaining six patients, two required no treatment, two only required the use of a collar but two did have surgical intervention, this decision being based on the findings seen in the initial films. However, 285 films (59%) were judged inadequate due either to inadequate F/E (150 patients, 31%) or poor visualization (194 patients, 40%). There were three false positives all subsequently cleared by other studies and there were no false negatives. From the chart review, there were no complications or deaths attributable to the procedure. CONCLUSION: Although we were unable to find any complication or deaths directly attributable to the procedure, the clinicians abandoned passive F/E views in obtunded patients on the grounds of expense. Our present method of "clearing" a cervical spine in an obtunded patient is a cross-table lateral radiograph followed by a high-resolution thin-slice CT scan with sagittal and coronal reconstruction. We are against the use of routine MRI studies and of a forced F/E view in these patients.