Evaluation of a Novel Drain Stripping Device for Reducing Surgical Drain Complications
Evaluation of a Novel Drain Stripping Device for Reducing Surgical Drain Complications
The purpose of this research is to evaluate how well a novel surgical site drain tube clearing device works, and how easy it is for care staff to use.
The purpose of this research is to gather information on the ease of use, effectiveness, and potential ability to reduce post-surgical drain complications of a drain stripping device which was developed and made here at the Mayo Clinic. The device has been patented and has been tested in laboratory conditions, but it has not yet been evaluated by the FDA or cleared for marketing yet since it is a device that poses minimal risk to patients. The device is a plastic clamp which is used to move fluid through the drain tubing to keep the tubing clear and free flowing. The current method (standard of care) for doing this simply involves running fingers down the tubing to drain the fluid, which can be inadequate and sometimes physically challenging. The primary goal of the study is to get feedback from nurses using the device in a clinical setting. There are approximately 80 nurses working the hospital unit which cares for patients who may have a post-surgical drain emplaced. We will gather their feedback via an anonymous survey which will be available to the nurses on the Mayo Clinic Intranet. Secondary goals of the study attempt to ascertain the potential effect of device use upon patient outcomes. Inadequate draining of surgical site fluid can sometimes create the need for additional interventions, including surgical revisions. The drain stripping device used in this study, has been developed to address these issues. Preliminary bench testing in laboratory conditions has not indicated any reason to believe that use of the device to clear surgical drain tubing poses any greater (or even different) risk to patients than the current standard of care (using bare fingers). Patients are routinely sent home with one or more surgical drains which are cleared by the patient using the current standard of care. Therefore, there is no safety related need to start with a small number of study subjects as is typical for an initial trial; and since this is not a device or drug which would be likely to show obvious benefit within a small cohort, we are seeking data regarding potential effect of study device upon patient outcomes from 420 study subject encounters (210 in each arm - device use versus current standard of care), as opposed to the small numbers of subjects usually seen in initial clinical trials.
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