Investigation of a New Compression Bandage System Combining Skin Protection, Padding and Compression in One Single Bandage and Comparing to an Existing One-component Bandage.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLohmann & Rauscher

About this trial

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.

Eligibility criteria

Qualifiers

Healthy intact skin with no clinical signs of chronic venous insufficiency and no signs of any dermatological condition such as eczema or psoriasis as assessed by investigating physician.

Ankle circumference > 18 cm (2 cm above ankle) as assessed by the investigating physician.

Disqualifiers

Known sensitivity to the study products (Rosidal 1C or Urgo K1) or any of their components

Chronic venous disease with CEAP ≥2

Ankle Brachial Pressure Index (ABPI) < 0.8 or >1.3

Ankle circumference <18 or > 32 cm

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

25 Participants
are grouped into 1 trial group

Sponsors and collaborators