BSN Medical GmbH
Although, a huge number of acute wounds is treated successfully every year, Health Care Professionals (HCPs) are facing more and more problems when treating skin damages or surgical incisions: The number of patients with fragile and/or sensitive skin is highly increasing. Such patients are having a skin integrity issue, meaning the skin is vulnerable to injury, often damaged, or unable to heal. The investigational medical devices (IMDs) of the planned clinical evaluation, Leukomed® T skin sensitive and Leukomed® T plus skin sensitive have been developed for treatment of acute wounds on patients with fragile or sensitive skin to provide a reliable but skin-friendly fixation and wound care option. The primary purpose of this clinical study is the evaluation of clinical performance to stay in place up to seven days and the safety of both dressings. Further, data on wearing comfort, product handling, pain during removal and quality of life are considered as secondary outcomes. The products will be used as part of routine wound care within the scope of their intended purpose without any additional invasive or burdensome examination.
Wounds and Injuries
Skin Diseases
Leukomed T / Tplus skin sensitive treatment
Study Type : | Observational |
Estimated Enrollment : | 47 participants |
Official Title : | C2654 - Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing |
Actual Study Start Date : | September 1, 2021 |
Estimated Primary Completion Date : | November 28, 2022 |
Estimated Study Completion Date : | November 30, 2022 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Practice Degenhardt
Bremen, Germany,
Not yet recruiting
Dortmund Clinic
Dortmund, Germany,
Not yet recruiting
orthoGroup
Hamburg, Germany,