PrepSleeve Clinical Validation

PrepSleeve precursor - UltraPrep, was studied in two different locations. Below you will find some extracts of the publications referring to those two studies. 

 J Webb1, R Hilliam2, LC Bainbridge, Pulvertaft Hand Unit, Derby Teaching Hospitals NHS Foundation Trust Derby, UK 

1. Consultant plastic Surgeon, University Hospital Birmingham 

2. Director of Teaching for Mathematics and Statistics, The Open University, Department of Mathematics and Statistics, Walton Hall, Milton Keynes, MK7 6AA, UK 

Abstract Surgical site infections (SSIs) can increase management costs and extend length of stay. We undertook a single blinded non-inferiority trial to evaluate the efficacy and utility of a novel system for pre-operative limb antisepsis.

Key words: Limb antisepsis; Safe working environment 

Discussion All antiseptic agents recommend a significant period of contact before surgery starts to maximise efficacy. The reduction of CFUs in the study group may be due to the prolonged duration of contact with wet alcohol, as all other elements in the two study groups were identical. It is also possible that the plastic sleeve encourages a more even coverage of antiseptic solution through capillary action between the skin and sleeve. This study was adequately powered for the outcome and showed a statistically significant difference. A limitation may be that it was undertaken on the upper limb when the main use of the sleeve is probably for lower limb surgery. However whilst the bacterial load on an unwashed foot may be different to a hand, the relative effectiveness of the Limb Sleeve would be maintained. We have not identified a minimum adequate amount of antiseptic agent for a lower limb; however we recommend 50-60ml based on our experience. We believe this provides an opportunity to control more rigorously the volume and cost of antiseptic used. We have not been able to find details of numbers of staff complaining of back pain in theatres, but the anecdotal evidence suggests a significant risk of injury. Removing all need for the theatre staff, apart from the surgeon, to lift the limb reduces significantly the risk of back injury which is an obligation on all employers. 

Conclusion The system was designed to reduce theatre time, reduce lifting as far as possible, prolong antiseptic contact as long as possible and reduce wastage. The study results seem to support these aims.

 Mallory M. Przybylski Hall, DPM ; Daniel T. Hall IV, DPM; Laura Ikuma, PhD 

Abstract: The primary objectives of surgery departments should be patient safety, block time utilization, and OR efficiency. Reducing preparation time in the OR can improve OR efficiency and utilization, but only if patient safety is maintained. This study evaluated a novel device, a sterile, medical-grade plastic bag applied to the upper or lower extremity in the pre-operative holding area, which allows for skin disinfection outside the OR. The study compared OR preparation times and antiseptic efficacy for traditional methods versus using the device on 115 patients undergoing podiatric or orthopedic surgeries (upper and lower extremities) in one hospital. The device significantly reduced skin preparation time in the OR from 17 to 11 minutes (35.2% reduction, p<0.01. Skin antisepsis met safety standards of <15 CFUs for all cases regardless of preparation type (p = 0.14) at 48h and 72h.

Key words: Infection control, pre-operative antisepsis, surgical site preparation, prevention surgical site infection, OR efficiency

Discussion : This study investigated the benefits of using a new medical device for surgical skin preparation. The device allows for skin disinfection outside the OR in the pre-operative holding area, which in theory can reduce the use of costly OR resources, assuming the efficacy of the device is Page 11 of 21 AORN Journal For Review Only equivalent or better than conventional skin preparation techniques. The study followed 115 patients, divided into conventional and the device groups, through lower and upper extremity podiatric and orthopedic same-day surgeries to record times required and efficacy of skin preparation (measured by bacterial CFUs at 48 and 72 hours post-disinfection). Overall, the preparation time in the OR decreased by approximately 6 min (35%) while efficacy was statistically equivalent for both types of skin preparation. Reducing OR prep time has two major advantages. First, it saves costs of using already strained OR resources by shifting some work to the pre-operative holding area. Second, it reduces the time the patient spends under anesthesia, which could lead to improved outcomes (Ong et al. 2008). There are some potential drawbacks of using the device that can be addressed in future studies. Transferring preparation time outside the OR may not save as much overall surgical costs depending on how a hospital bills. Resources required in the pre-operative holding area are less expensive than the actual OR, but capturing those savings may be difficult. Furthermore, moving work to a different location may not decrease overall time for the patient. Future studies may take a more comprehensive approach to tracking time and resources used. Specifically, economic effects can be documented to compare the cost of the device, changes in pre-operative staffing needs, shifts in procedures to take advantage of reduced preparation times in the operating room, and patient feedback on comfort.

Future studies should evaluate expanded settings and surgery types. The surgeries were limited to hands and feet, and to three surgeons at one hospital, constraining the patient flow steps to one example. The impact of using the device may differ depending on the surgical location, physical layout of the environment, and flow of patients through various care providers. 

Conclusion: This initial evaluation of the device shows that OR preparation time can be reduced by 35% for podiatric and orthopedic cases of the hands and feet while maintaining equivalent efficacy in terms of disinfection to conventional preparation methods. This device has the ability to optimize OR utilization leading to cost reduction and improved workflow. Likely, additional time savings can be achieved as nursing staff become more familiar with the device and efficiency improves.