CC BY 4.0 · Phlebologie 2022; 51(01): 21-30
DOI: 10.1055/a-1487-4194
Originalarbeit

Static Stiffness Index of Two Multicomponent Bandage Compression Systems: Results of a Randomized Controlled Trial on Healthy Volunteers

Artikel in mehreren Sprachen: deutsch | English
1   Angiologe, Saint Mandé, Frankreich
,
Florence Balet
2   Freiberufliche Krankenschwester, Pélissane, Frankreich
,
Bérengère Guidet
3   Klinische Projektleiterin, Intertek Clinical Research Services, Paris, Frankreich
,
4   Direktor der Abteilung für präklinische und klinische Forschung, Urgo Research Innovation and Development, Chenôve, Frankreich
› Institutsangaben
Gefördert durch: Urgo Research Innovation and Development

Abstract

Purpose To compare the performances of two multicomponent compression systems.

Methods In this randomised controlled trial, both legs of 25 healthy volunteers were randomly bandaged with either a new generation of compression system (UrgoK1, one unique bandage) or an established system (UrgoK2, two bandages), as a control. Both systems were worn day and night. Working and resting interfaces pressures were measured, and Static Stiffness Index (SSI) calculated, immediately after application and after 4 h, 24 h, 48 h and 72 h.

Results After 4 hours, similar high working pressures and moderate resting pressures were registered with both systems. Over time, changes in pressures and in SSI followed the same curves. After 48 h, a SSI ≥ 10 mmHg was reached with 88 % and 76 % of the tested and control systems, respectively, validating the non-inferior rigidity of the tested system (p = 0.016). Both systems presented good holding properties and were well tolerated, but the tested system was perceived as significantly more comfortable and eventually preferred to the control system by the majority of the volunteers.

Conclusion The new compression system achieved similar performances to the control, but its better acceptability could become an asset for patients’ compliance. These promising results need to be confirmed in a clinical study on patients with leg ulcers and/or oedema.



Publikationsverlauf

Artikel online veröffentlicht:
21. Dezember 2021

© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany