Clinical trial NCT04775316: Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing
Official title: C2654 - Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Wounds and Injuries
Skin Diseases
Lead sponsor: BSN Medical GmbH
Sponsor class: INDUSTRY
First posted: 2021-03-01
Enrollment: 47
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adhered dressing area after wear
timeFrame: 7 days after dressing application
Secondary outcomes:
measure: Skin damage
timeFrame: 7 days after dressing application
measure: Skin reddening
timeFrame: 7 days after dressing application
measure: Skin reactions
timeFrame: after 7 days
measure: Pain assessment
timeFrame: 7 days after dressing application
measure: Product Evaluation by patient
timeFrame: 7 days after dressing application
measure: Product Evaluation by Health Care Professional
timeFrame: at application day (day 0)
measure: Infection
timeFrame: 7 days after dressing application
Other outcomes:
Locations:
city: Bremen
country: Germany
facility: Practice Degenhardt
city: Dortmund
country: Germany
facility: Klinikum Dortmund
city: Hamburg
country: Germany
facility: orthoGroup
Study officials:
References: