Trials / Terminated
TerminatedNCT04775316
Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing
C2654 - Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 47 (actual)
- Sponsor
- BSN Medical GmbH · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Leukomed T / Tplus skin sensitive treatment | Application of sterile wound dressing. |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2022-11-28
- Completion
- 2022-11-30
- First posted
- 2021-03-01
- Last updated
- 2022-12-02
Locations
3 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT04775316. Inclusion in this directory is not an endorsement.