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

BSN Medical

Status: Terminated

Conditions: Skin Diseases; Wounds and Injuries

Treatments: Device: Leukomed T / Tplus skin sensitive treatment

Study type: Observational

Funder types: Industry

Identifiers

NCT04775316

C2654

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

47 participants in 1 patient group

Patients with fragile skin

Description:

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.

Treatment:

Device: Leukomed T / Tplus skin sensitive treatment