Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with fragile skin Patient aged 65 years and older presenting with fragile skin and require wound care of an acute wound (laceration or surgical wound). Siliconized sterile wound dressing will be applied for a treatment period of 7 days. |
Device: Leukomed T / Tplus skin sensitive treatment
Application of sterile wound dressing.
|
Outcome Measures
Primary Outcome Measures
- Adhered dressing area after wear [7 days after dressing application]
Percentage of adhered dressing area 7 days after application
Secondary Outcome Measures
- Skin damage [7 days after dressing application]
skin damage after dressing removal
- Skin reddening [7 days after dressing application]
Reddening of the skin 30 min after dressing removal
- Skin reactions [after 7 days]
Further skin reactions after dressing removal
- Pain assessment [7 days after dressing application]
Pain at dressing removal
- Product Evaluation by patient [7 days after dressing application]
Judge wearing comfort
- Product Evaluation by Health Care Professional [at application day (day 0)]
Assessment of handling, application and and re-application
- Infection [7 days after dressing application]
Assess signs of wound infection
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men, women or diverse
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≥ 65 years of age
-
Patient is mentally and physically able to participate in this study
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Signed informed consent to participate in this study
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Fragile skin condition
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Acute wound (surgical wound or laceration), indicated for treatment with the investigational products for a time period of 7 days
Exclusion Criteria:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Practice Degenhardt | Bremen | Germany | ||
| 2 | Klinikum Dortmund | Dortmund | Germany | ||
| 3 | orthoGroup | Hamburg | Germany |
Sponsors and Collaborators
- BSN Medical GmbH
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C2654