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NCT04775316 | Terminated | Wounds and Injuries


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

BSN Medical GmbH

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 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.

Condition or disease

Wounds and Injuries

Skin Diseases

Intervention/treatment

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
Criteria
Inclusion Criteria
  • Men, women or diverse
  • ≥ 65 years of age
  • Patient is mentally and physically able to participate in this study
  • Signed informed consent to participate in this study
  • Fragile skin condition
  • Acute wound (surgical wound or laceration), indicated for treatment with the investigational products for a time period of 7 days
Exclusion Criteria
  • Infection of the target wound
  • Alcohol or drug addiction
  • Known sensitivity or allergy to any component of the study product
  • Patients who participate in any other clinical study investigating drugs or medical devices

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

Location Details


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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Germany,

Practice Degenhardt

Bremen, Germany,

Not yet recruiting

Germany,

Dortmund Clinic

Dortmund, Germany,

Not yet recruiting

Germany,

orthoGroup

Hamburg, Germany,

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