A prospective, monocentric, observational randomised controlled pilot study of two all-in-one multicomponent...

In this pilot study, two all-in-one multicomponent compression systems designed for use in phlebological diseases were evaluated for their sub-bandage resting and working pressure performance, static stiffness index, and wearing acceptance over the course of one week in a cohort of healthy volunteers.

This was a prospective, monocentric, observational, within-person randomised controlled pilot comparison study. The investigational device (InD) and the comparator device (CoD) were randomly applied to the lower legs of the participants for continuous wear, both during the day and night, for one week. The sub-bandage resting and working pressures were measured on four visits by pneumatic pressure sensors applied underneath the bandages (day of application, day 1, day 3 and final day). The height of the bandage from the foot sole to the bandage rim was measured to determine the bandage slippage over time. Participants were asked to assess comfort during and at the end of enrolment. The investigators evaluated the padding and skin protection effect of the bandages for each participant.

A total of 22 healthy volunteers took part in the study. A mean resting and working pressure within the relevant therapeutic range of 20-40mmHg was achieved with both bandage systems. At application, the mean pressures were 46mmHg with both bandages and dropped to within the therapeutic range by the next day. The mean bandage slippage with both bandages was <5cm on the third day. Both bandages were well tolerated, except for itching, which was experienced significantly more with the CoD than with the InD (mean tolerance rating of at least 'acceptable' in 83% (InD) and 67% (CoD) of participants, as measured on a four-point scale). The participants confirmed 'satisfactory' or greater wearing comfort and ankle mobility (mean rating: 89% (InD) and 93% (CoD) of participants, as measured on a six-point scale).

Both bandages achieved therapeutic working pressures and tolerable resting pressures. Both products were well tolerated. Confirmation in a larger cohort of patients with venous leg ulcers in a real-world setting reflecting clinical routine is recommended. The study is registered with ClinicalTrials.gov database (ID NCT06728137).