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Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing

Wounds and Injuries Clinical Trial

Official title:
C2654 - Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04775316
Study type Observational
Source BSN Medical GmbH
Contact
Status Terminated
Phase
Start date September 1, 2021
Completion date November 30, 2022
View Details
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