Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04775316
Status:
TERMINATED
Last Update Posted:
2022-12-02
First Post:
2021-02-25
Brief Title:
Prospective International Multicenter Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing
Sponsor:
BSN Medical GmbH
Organization:
BSN Medical GmbH
Study Overview
Official Title:
C2654 - Prospective International Multicenter Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
site stopped recruiting due to limited personell resources
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None