Compression therapy of leg ulcers with PAOD.
Objectives: To assess the clinical safety of a new short-stretch 2-layer compression system (3MtmCobantm2 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 (3MtmCobantm2 Lite) was safe and well tolerated in subjects with moderate PAOD.
University of Greifswald, Fleischmannstrasse 42/43, Greifswald, Germany.
Andrea
A
Ladwig
University of Greifswald, Fleischmannstrasse 42/43, Greifswald, Germany.
Hermann
H
Haase
3M Deutschland GmbH, Neuss, Germany.
Jens
J
Bichel
3M Deutschland GmbH, Neuss, Germany.
Jan
J
Schuren
University of Greifswald, Fleischmannstrasse 42/43, Greifswald, Germany juenger@uni-greifswald.de.
Michael
M
Jünger
2-layer short-stretch compression therapy; Leg ulcer with moderate PAOD; hypoxia-related pain; pressure-related skin damage