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

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

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.

Study Overview

• Status: Terminated
• Conditions: Wounds and Injuries; Skin Diseases
• Intervention / Treatment: Device: Leukomed T / Tplus skin sensitive treatment

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• Germany
  • Bremen, Germany
    • Practice Degenhardt
  • Dortmund, Germany
    • Klinikum Dortmund
  • Hamburg, Germany
    • orthoGroup

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects 65 years and older suffering from skin changes causing fragile skin. Extrinsic factors and intrinsic factors leading to skin damages or pathological changes: extremes of ager (>80 years), race/ethnicity, underlaying medical conditions, dermatological conditions, malnutrition, dehydration, drying of the skin, prolonged exposure to moisture, certain medication, current radiotherapy, photedamage, previous removal of tapes/dressings/devices, repeated taping. Subject presenting on of the criteria above can be included.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: BSN Medical GmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): November 28, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Skin Diseases
• Other Study ID Numbers: C2654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No