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.

2023-05 Rosidal® 1C Pilot Study. Prospective, Mono-centric, Observational Randomized Controlled Study in Healthy Volunteers

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• Venous echo-Doppler with recognizable abnormalities

• History of

  • malignant ulcer
  • clinically infected wound
  • peripheral arterial occlusive diseases,
  • cardiac insufficiency or cardiac disease such as congestive heart failure, coronary artery disease, myocardial infarction, coronary artery bypass graft
  • cerebrovascular disease
  • liver or renal disease
  • septic phlebitis,
  • phlegmasia coerulea dolens,
  • sensation disorders of the skin
  • eczema, psoriasis

• Use of diuretics, antihypertension or drugs that influence the capillary infiltration

• Comorbidities that could affect compression therapy, particularly diseases causing oedema

• Reliable severe malnutrition

• Diabetes Mellitus

• BMI > 30 kg/m2

• Pregnancy or breast feeding

• Participation in an interventional clinical trial within the last 3 months and during participation in this study

• Participant is analphabet