Advanced Medical Balloons (AMB) announced positive data from their HYDRA-PMCF study on hygh-tec®, a new polyurethane fecal management system for ICU patients. The study showed an 89.3% success rate in preventing leakage and a 94.2% safety profile with minimal signs of infection. Full results will be presented at the ABA Annual Meeting and WOCNext 2025.
This data is crucial for addressing the pervasive issue of fecal incontinence in intensive care settings. Current stool drainage systems suffer from high leakage rates, impacting patient well-being, increasing nursing workload, and contributing to higher healthcare costs due to complications like skin breakdown and infections. hygh-tec®’s demonstrated efficacy and safety profile offers a potential solution to these significant challenges, potentially improving patient outcomes and optimizing resource allocation in critical care.
The HYDRA-PMCF study involved 39 ICU patients and evaluated the system’s performance over 1,110 nursing shifts. The average drainage duration was 10.8 days. Leakage, defined as a contamination score of 3 or 4, occurred in only 10.7% of patients. The GLOBIAD score, used to assess perianal skin health, indicated no signs of infection in 94.2% of the observed days. Importantly, no device-related adverse events were reported.
The positive results from the HYDRA-PMCF study reinforce the potential of hygh-tec® to transform fecal management in critical care. This could lead to wider adoption of the system, benefiting both patients and healthcare providers. Further presentations of the full study data at upcoming conferences will likely generate increased interest and pave the way for further research and development in this important area of patient care.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
