Poster Presentation 50th International Society for the Study of the Lumbar Spine Annual Meeting 2024

INTRODUCTION

Tissue exposed to theatre air during surgery is susceptible to evaporative heat and moisture loss. The resulting local hypothermia and desiccation disrupts the internal milieu of the patient and may lead to delayed healing and increase the risk of surgical site infections (SSIs). An SSI typically doubles a hospital’s per patient cost due to complications such as increased length of stay, implant revisions, and mortality. SSI’s make up approximately half of all healthcare associated infections, and in the United States alone result in an estimated cost of over US$10 Billion.

HumiGard^TM, a novel device (Figure 1), was developed to maintain homeostasis through the delivery of humidified, warmed air (37ºC, 100% relative humidity) over a surgical incision site. Here, we present the findings from the first-in-human clinical investigation.

METHODS

Twenty-eight patients undergoing elective, 1-2 level spinal decompression between L1-sacrum via open techniques using a posterior midline incision were equally randomised to receive the intervention (HumiGard) or control (standard of care). The primary outcome was the temperature of the incision site measured at fifteen-minute intervals using a thermal camera.

 RESULTS

The average starting skin temperature across all patients was 33°C. The temperature in the control cases dropped, on average, 1°C every 15 mins. The average wound edge temperature, 60 minutes after knife to skin, was 29°C. In contrast, with HumiGard, the average wound edge temperature was 37°C throughout the surgery (p<0.01). The tissue was noted as appearing more red, moist, and healthier at the end of the procedure when HumiGard was used compared to the control. No adverse events were recorded in the trial. There was no difference in blood loss, core temperature, duration of procedure or patient demographics between the control and HumiGard groups. In 100% of cases, the operating surgeon scored HumiGard as ‘easy’ to apply and ‘the same as normal’ for ease of performing the procedure with HumiGard in place.

CONCLUSION

HumiGard is safe and effective at maintaining physiological conditions over an incision site during spinal surgery. It is easy to apply and allows the procedure to be performed as normal. Use of HumiGard may complement existing infection prophylaxis measures to further reduce the risk of SSI in posterior spinal surgery.

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Figure 1: On patient use of HumiGard captured during the trial. Note: consent obtained for use of image.