Wounds and InjuriesNCT04775316
Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing
An observational study of Wounds and Injuries and Skin Diseases, run by BSN Medical GmbH at 3 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Wounds and Injuries, Skin Diseases
- What is being tested?
- Leukomed T / Tplus skin sensitive treatment
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Sep 2021to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Germany3 sites
Practice Degenhardt
Bremen
Klinikum Dortmund
Dortmund
orthoGroup
Hamburg
About this study
Official title: 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.
- Conditions
- Wounds and Injuries, Skin Diseases
- Being tested
- Leukomed T / Tplus skin sensitive treatment
- Medical subject headings
- Wounds and Injuries, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukomed T / Tplus skin sensitive treatmentDevice
Application of sterile wound dressing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Leukomed T / Tplus skin sensitive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhered dressing area after wear
Percentage of adhered dressing area 7 days after application
Measured: 7 days after dressing application
Secondary outcomes (7)
Skin damage
skin damage after dressing removal
Measured: 7 days after dressing application
Skin reddening
Reddening of the skin 30 min after dressing removal
Measured: 7 days after dressing application
Skin reactions
Further skin reactions after dressing removal
Measured: after 7 days
Pain assessment
Pain at dressing removal
Measured: 7 days after dressing application
Product Evaluation by patient
Judge wearing comfort
Measured: 7 days after dressing application
Product Evaluation by Health Care Professional
Assessment of handling, application and and re-application
Measured: at application day (day 0)
Infection
Assess signs of wound infection
Measured: 7 days after dressing application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Sep 2021
- Primary completion28 Nov 2022
- Study completion30 Nov 2022
Why it stopped: site stopped recruiting due to limited personell resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- BSN Medical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775316
- Sponsor's protocol ID
- C2654
- Status last verified
- Nov 2022
- First submitted
- 25 Feb 2021
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C2654 - Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing
- ClinicalTrials.gov ID
- NCT04775316
- Acronym / sponsor ID
- C2654
- Conditions
- Wounds and Injuries, Skin Diseases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: site stopped recruiting due to limited personell resources
- Enrolment
- 47 participants (actual)
- Lead sponsor
- BSN Medical GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with fragile skin | – | Device: Leukomed T / Tplus skin sensitive treatmentPatient 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leukomed T / Tplus skin sensitive treatmentApplication of sterile wound dressing. | Device | Patients with fragile skin |
Primary outcome
Adhered dressing area after wear
Time frame: 7 days after dressing application
Percentage of adhered dressing area 7 days after application
7 secondary outcomes
Skin damage
Time frame: 7 days after dressing application
Skin reddening
Time frame: 7 days after dressing application
Skin reactions
Time frame: after 7 days
Pain assessment
Time frame: 7 days after dressing application
Product Evaluation by patient
Time frame: 7 days after dressing application
Product Evaluation by Health Care Professional
Time frame: at application day (day 0)
Infection
Time frame: 7 days after dressing application
Results and safety
The study was stopped early (reason given: site stopped recruiting due to limited personell resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Individual participant dataSharing planned: No. data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injuries and Skin Diseases, run by BSN Medical GmbH at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: site stopped recruiting due to limited personell resources). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adhered dressing area after wear (time frame: 7 days after dressing application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.