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

Study Overview
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Brief Summary
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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.

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

Conditions
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Wounds and Injuries, Skin Diseases

Intervention / Treatment
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* Device: Leukomed T / Tplus skin sensitive treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with fragile skin<br>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<br>* Application of sterile wound dressing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhered dressing area after wear | Percentage of adhered dressing area 7 days after application | 7 days after dressing application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin damage | skin damage after dressing removal | 7 days after dressing application | 
| Skin reddening | Reddening of the skin 30 min after dressing removal | 7 days after dressing application | 
| Skin reactions | Further skin reactions after dressing removal | after 7 days | 
| Pain assessment | Pain at dressing removal | 7 days after dressing application | 
| Product Evaluation by patient | Judge wearing comfort | 7 days after dressing application | 
| Product Evaluation by Health Care Professional | Assessment of handling, application and and re-application | at application day (day 0) | 
| Infection | Assess signs of wound infection | 7 days after dressing application |