NCT06728137

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Lohmann & Rauscher · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteers

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-03-01
• Completion: 2025-04-01
• First posted: 2024-12-11
• Last updated: 2025-01-13

Locations

1 site across 1 country: Italy