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

Terminated

• Conditions: Wounds and Injuries; Skin Diseases
• Interventions: Device: Leukomed T / Tplus skin sensitive treatment

• Registration Number: NCT04775316
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-01
• Study Start: 2021-09-01
• Status Verified: 2022-11
• Primary Completion: 2022-11-28
• Study Completion: 2022-11-30
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with fragile skin	Leukomed T / Tplus skin sensitive treatment	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.

Primary Outcome Measures

Name	Time	Method
Adhered dressing area after wear	7 days after dressing application	Percentage of adhered dressing area 7 days after application

Secondary Outcome Measures

Name	Time	Method
Infection	7 days after dressing application	Assess signs of wound infection
Product Evaluation by patient	7 days after dressing application	Judge wearing comfort
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
Pain assessment	7 days after dressing application	Pain at dressing removal
Skin reactions	after 7 days	Further skin reactions after dressing removal
Product Evaluation by Health Care Professional	at application day (day 0)	Assessment of handling, application and and re-application

Trial Locations

Locations (3)

Practice Degenhardt; 🇩🇪 Bremen, Germany

orthoGroup; 🇩🇪 Hamburg, Germany

Klinikum Dortmund; 🇩🇪 Dortmund, Germany