Andrea Ladwig1, Hermann Haase1, Jens Bichel2, Jan Schuren2, Michael Jünger3. 1. University of Greifswald, Fleischmannstrasse 42/43, Greifswald, Germany. 2. 3M Deutschland GmbH, Neuss, Germany. 3. University of Greifswald, Fleischmannstrasse 42/43, Greifswald, Germany juenger@uni-greifswald.de.
Abstract
Objectives: To assess the clinical safety of a new short-stretch 2-layer compression system (3Mtm Cobantm 2 Lite) in patients with peripheral arterial occlusive disease (PAOD). This system combines a low resting pressure with a high working pressure. Methods: A pilot study was performed in 15 subjects with moderate PAOD, i.e. an ABPI of 0.5-0.8. Co-existing chronic venous insufficiency or leg ulcer was not mandatory. All subjects received the compression system which was reapplied at each study visit (days 1, 2, 3, 4, 7, 10, 14). The safety parameters were: sub-bandage pressure immediately after application, pressure-related skin damage, hypoxia-related pain, and adverse events. A product comfort questionnaire was completed at the last visit. Results: The average sub-bandage pressure of 30 mmHg defined by the protocol was achieved. No pressure-related skin damage or hypoxia-related pain was found. The reported adverse device effects were as expected for compression therapies, including dry skin and pruritus. The product comfort questionnaire completed by the subjects showed a good tolerability profile. Conclusion: The short-stretch 2-layer compression system (3Mtm Cobantm 2 Lite) was safe and well tolerated in subjects with moderate PAOD.
Objectives: To assess the clinical safety of a new short-stretch 2-layer compression system (3Mtm Cobantm 2 Lite) in patients with peripheral arterial occlusive disease (PAOD). This system combines a low resting pressure with a high working pressure. Methods: A pilot study was performed in 15 subjects with moderate PAOD, i.e. an ABPI of 0.5-0.8. Co-existing chronic venous insufficiency or leg ulcer was not mandatory. All subjects received the compression system which was reapplied at each study visit (days 1, 2, 3, 4, 7, 10, 14). The safety parameters were: sub-bandage pressure immediately after application, pressure-related skin damage, hypoxia-related pain, and adverse events. A product comfort questionnaire was completed at the last visit. Results: The average sub-bandage pressure of 30 mmHg defined by the protocol was achieved. No pressure-related skin damage or hypoxia-related pain was found. The reported adverse device effects were as expected for compression therapies, including dry skin and pruritus. The product comfort questionnaire completed by the subjects showed a good tolerability profile. Conclusion: The short-stretch 2-layer compression system (3Mtm Cobantm 2 Lite) was safe and well tolerated in subjects with moderate PAOD.
Authors: F Pannier; T Noppeney; J Alm; F X Breu; G Bruning; I Flessenkämper; H Gerlach; K Hartmann; B Kahle; H Kluess; E Mendoza; D Mühlberger; A Mumme; H Nüllen; K Rass; S Reich-Schupke; D Stenger; M Stücker; C G Schmedt; T Schwarz; J Tesmann; J Teßarek; S Werth; E Valesky Journal: Hautarzt Date: 2022-04-19 Impact factor: 1.198