Background:
Open fractures of the talar body and neck are uncommon. Previous reports of associated deep infection rates and resulting surgical requirements vary widely. The primary objective of this ...study is to report the incidence of deep infections for isolated open talar body and neck fractures, and secondarily the incidence and number of total surgeries performed (TSP), secondary salvage procedures (SSPs), and nonsalvage procedures (NSPs).
Methods:
Retrospective case-control study of 32 consecutive isolated open talus fracture patients (22 neck, 10 body) were followed for an average of 39.2 months.
Results:
Five (15.6%) fractures developed deep infections. Fifty percent of open body fractures became infected compared with 0% of neck fractures (P < .001). There was no difference between infected group (IG) and uninfected fracture group (UG) with respect to age, sex, body mass index, tobacco, diabetes, vascular disease, open fracture type, wound location, hours to irrigation and debridement, or definitive treatment. The majority (92.6%) of UG fractures used a dual incision with open wound extension. There were more single extensile approaches in the IG group (P = .04). The IG required 5.8 TSP per patient compared with 2.1 in the UG (P = .004). All (100%) of the IG required an SSP compared with 29.6% of the UG (P = .006). All (100%) of the IG required an NSP compared to 40.7% of the UG (P = .043). In the IG, 2.8 NSPs per patient were required after definitive surgery compared with 1.18 in the UG (P = .003). Of those followed 1 year, the incidence of SSP remained higher in the IG (P = .016).
Conclusion:
The incidence of deep infection following isolated open talar fractures is high and occurs disproportionally in body fractures. Infected fractures required nearly 6 surgeries, and all required SSP.
Level of Evidence:
Level IV, prognostic.
Graphical Abstract
This is a visual representation of the abstract.
•We designed this study to demonstrate the use of BioCompute Objects (BCO) to communicate results, obtained from next generation sequencing (NGS) data collected during a clinical trial, to a ...regulatory agency.•The BCO framework facilitates transparency and reproducibility, thereby reinforcing trust in the regulatory submission process.•A template BCO makes benchmarking and direct comparisons between different analysis pipelines more feasible.•The outcomes of this project indicate that BCO can capture the data processing workflow and can facilitate the submission of analyses to the US Food and Drug Administration (FDA).•We demonstrate the ability of a template BCO, with a verification kit, to communicate NGS analyses clearly within regulatory submissions.
This project demonstrates the use of the IEEE 2791–2020 Standard (BioCompute Objects BCO) to enable the complete and concise communication of results from next generation sequencing (NGS) analysis. One arm of a clinical trial was replicated using synthetically generated data made to resemble real biological data and then two independent analyses were performed. The first simulated a pharmaceutical regulatory submission to the US Food and Drug Administration (FDA) including analysis of results and a BCO. The second simulated an FDA review that included an independent analysis of the submitted data. Of the 118 simulated patient samples generated, 117 (99.15%) were in agreement in the two analyses. This process exemplifies how a template BCO (tBCO), including a verification kit, facilitates transparency and reproducibility, thereby reinforcing confidence in the regulatory submission process.
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