The goal of this study is to learn about the pressure that can be maintained by a new compression bandage over the course of seven days in healthy volunteers. This bandage combines skin protection, padding and compression in one single bandage. It will be applied to the participants lower legs. A similar device will be applied to the other lower leg of the participant. A randomisation method is used for the assignment of the bandages to the participants legs. Researchers will compare the bandage pressures of both bandages. The so-called sub-bandage pressure will be measured at the day of application and on the next day, the third day and the last day. Participants will also be asked about the wearing comfort of both bandages.
Study Type
OBSERVATIONAL
Enrollment
25
Department of Clinical and Experimental Medicine, University of Pisa, UOC Dermatologia Universitaria, Santa Chiara Hospital AOUP
Pisa, Italy
RECRUITINGPercentage of subjects with static stiffness index SSI ≥ 10 mmHg over the course of 7 days
The pressure is measured underneath the compression bandage ("sub-bandage pressure") which is applied onto the lower leg. A pressure sensor is positioned in between the skin and the compression bandage. The static stiffness index is the pressure difference between active standing and lying.
Time frame: Day 0, 1, 3, 7
Percentage of subjects with resting pressures higher than 20 mmHg and 40 mmHg up to day 7
The resting pressures are obtained during muscle relaxation or rest when the participant is lying.
Time frame: Day 0, 1, 3, 7
Rate of participants assessing the wearing comfort on a 6-level scale.
Participants will be asked on their experience on the wearing comfort like mobility of the ankle and slippage or sensations like heat, sweating or pain.
Time frame: Day 0, 1, 7
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