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

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04775316
• Other study ID #: C2654
• Status: Terminated
• Start date: September 1, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: November 2022
• Source: BSN Medical GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: November 30, 2022
• Est. primary completion date: November 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Diseases
• Wounds and Injuries

Intervention

Device:
• Leukomed T / Tplus skin sensitive treatment
Application of sterile wound dressing.

Locations

Country	Name	City	State
Germany	Practice Degenhardt	Bremen
Germany	Klinikum Dortmund	Dortmund
Germany	orthoGroup	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
BSN Medical GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adhered dressing area after wear	Percentage of adhered dressing area 7 days after application	7 days after dressing application
Secondary	Skin damage	skin damage after dressing removal	7 days after dressing application
Secondary	Skin reddening	Reddening of the skin 30 min after dressing removal	7 days after dressing application
Secondary	Skin reactions	Further skin reactions after dressing removal	after 7 days
Secondary	Pain assessment	Pain at dressing removal	7 days after dressing application
Secondary	Product Evaluation by patient	Judge wearing comfort	7 days after dressing application
Secondary	Product Evaluation by Health Care Professional	Assessment of handling, application and and re-application	at application day (day 0)
Secondary	Infection	Assess signs of wound infection	7 days after dressing application