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Abstract
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INTRODUCTION: A commercially available snake bite device was pilot tested for novel use as a method of hemostasis and wound repair at a noncompressible site in a live swine model. The device is light, is plastic, uses a hook-and-loop strap attachment, and is easily deployed. The device could offer a method for the field repair of an actively bleeding laceration at a noncompressible site in an austere environment.
MATERIALS AND METHODS: This was an interventional, prospective, controlled study in a large animal model. The study was approved by the Rhode Island Hospital Institutional Review Board (IRB) and the Animal Welfare Committee/Institutional Animal Care and Use Committee and the Lifespan Research Conflict of Interest Committee. Each animal acted as its own control. Blood loss was measured and compared between repairs of standardized incisions with and without the device's application. The lacerations were sutured closed. Two proceduralists alternated tasks of wound repair versus blood collection. Blood loss was measured by using gauze sponges to capture the blood during a 30-second free-bleeding period and during the repair itself. Using a one sample t-test (the expected difference in blood loss between the two incision repair methods = 0 if the null hypothesis were true), we calculated the mean difference in the deltas between the repair methods.
RESULTS: The mean delta difference was 3.1 g (SE ± 0.97). The t-test demonstrated that there was a significantly greater blood loss during the standard repair method, t(9) = 3.11, P < 0.01 than during the repair with the device in place (see Fig. 2). A statistical power analysis conducted showed that with a sample size of 10 animals, there was sufficient statistical power to detect this significant effect (β = 0.82, α < 0.05, one-tailed).
CONCLUSIONS: There was statistically significantly less blood loss during the repairs with the device's application. This feasibility experiment demonstrates that a commercially available snakebite device may be useful for hemostasis during laceration repair at anatomic sites not amenable to application of tourniquets or compressive dressings. Strengths of the study include the prospective controlled design, including the use of each animal as its own control; alternating proceduralists to account for any variability in suturing efficiency; and the statistical significance of the results despite the small number of subjects. One weakness is that the time required for each repair was not measured. The device's portability and reusability suggest applicability in austere medical environments. Future studies could include timing the repairs, using a skin stapler or wound adhesive instead of sutures, applying a hemostatic agent before the repair, and sequentially applying the device to wounds longer than the device.
Language: en |