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

NCT04775316 | Terminated

• 1 other identifier: C2654
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 3

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.

Conditions

Wounds and Injuries; Skin Diseases

Outcome Measures

Primary Outcomes (1)

• Adhered dressing area after wear

  Percentage of adhered dressing area 7 days after application

  7 days after dressing application

Secondary Outcomes (7)

• Skin damage

  7 days after dressing application

• Skin reddening

  7 days after dressing application

• Skin reactions

  after 7 days

• Pain assessment

  7 days after dressing application

• Product Evaluation by patient

  7 days after dressing application

Study Arms (1)

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

Interventions

Leukomed T / Tplus skin sensitive treatment DEVICE

Application of sterile wound dressing.

Patients with fragile skin

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BSN Medical GmbH: lead

Study Sites (3)

Practice Degenhardt

Bremen, Germany

Location

Klinikum Dortmund

Dortmund, Germany

Location

orthoGroup

Hamburg, Germany

Location

MeSH Terms

Conditions

Wounds and Injuries; Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: September 1, 2021
• Primary Completion: November 28, 2022
• Study Completion: November 30, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)