Sealing efficiency and safety of a polyurethane-based fecal management system in intensive care: results from a real-world study

Objective - Fecal management systems (FMSs) are critical for preventing skin irritations and anal dermatitis in intensive care. A polyurethane-based system (hygh-tec® [Advanced Medical Balloons]) has been introduced in the European Union and United States. This real-world observational study aimed t...

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Main Authors: Gutting, Tobias (Author) , Brobeil, Angelika (Author) , Strach, Lisa (Author) , Stricker, Elisabeth (Author) , Boxberger, Monica (Author) , Trierweiler-Hauke, Birgit (Author) , Heine, Clemens (Author) , Michl, Patrick (Author) , Luntz, Steffen P. (Author) , Robert, Bérénice (Author) , Göbel, Fred (Author) , Weis, Christiane (Author) , Pfützner, Anreas (Author)
Format: Article (Journal)
Language:English
Published: 23 July 2025
In: Australian critical care
Year: 2025, Volume: 38, Issue: 5, Pages: 1-6
ISSN:1878-1721
DOI:10.1016/j.aucc.2025.101296
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.aucc.2025.101296
Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S1036731425001262
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Author Notes:Tobias Gutting, MD, Angelika Brobeil, CNS, BBA, Lisa Strach, CNS, Elisabeth Stricker, CNS, Monica Boxberger, MD, Birgit Trierweiler-Hauke, CNS, Clemens Heine, CNS, Patrick Michl, MD, Steffen Luntz, MD, Bérénice Robert, MSc, Fred Göbel, MD, Christiane Weis, MSc, Anreas Pfützner, MD

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520 |a Objective - Fecal management systems (FMSs) are critical for preventing skin irritations and anal dermatitis in intensive care. A polyurethane-based system (hygh-tec® [Advanced Medical Balloons]) has been introduced in the European Union and United States. This real-world observational study aimed to evaluate the sealing efficiency and safety of the system in routine care. - Methods - Thirty-nine patients were included in the descriptive analysis (18 females and 21 males; mean age: 66.4 ± 10.5 years; body mass index: 28.8 ± 11.7 kg/m2). Intensive care nurses documented findings related to sealing efficiency, anal lesions, and adverse events during their shifts. - Results - Sealing efficiency was assessed from 1110 shift reports. The mean device usage duration was 10.8 days (range: 3-31 days). No visible perianal contamination was noted in 76.0% of shift reports (n = 844). Relevant leakage was documented in 10.7% of cases and was independent of body mass index, anal sphincter muscle tone, and reason for admission. Stool consistency and patient vigilance had minimal influence. There were no device-related adverse events, and the incidence of anal lesions was 0.8% over 31 days of use. - Conclusion - The polyurethane-based FMS demonstrated excellent sealing efficiency, tolerability, and safety. Controlled studies are needed to confirm these findings and evaluate economic implications. FMSs can improve both work quality and patient safety. 
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