WoundNCT04731753
PMCF Study to Examine the Debridement Pad Cutimed DebriClean
An observational study of Wound, run by BSN Medical GmbH at 3 sites in 2 countries.
Trial summary
Documentation of the performance and safety of the debridement pad Cutimed DebriClean in daily clinical practice Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound
- What is being tested?
- mechanical debridement
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 27 Apr 2021to 30 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with superficial wounds in need of debridement, for example diabetic ulcers, venous and arterial ulcers, pressure sores, postoperative wounds and wounds healing by secondary intention, superficial burns, the absorption of exudate, slough and dry skin flakes.
Who may be able to join
- Male or female subjects aged 18 years or older with full legal competence
- Signed informed consent
- Subjects with wounds in need of debridement, especially diabetic ulcers, venous and arterial ulcers, pressure sores, postoperative wounds and wounds healing by secondary intention, superficial burns
- Superficial wound
- Minimum 30 % of the wound is covered by debris, necrosis or slough
- Wound size > 4 cm²
Who cannot join
- Subjects not willing to participate or to attend the scheduled study visit
- Known sensitivity or allergy to the product components
- Severe pain or hyperaesthesia in the wound area
- Patients who are pregnant or lactating
- Drug abuse or alcohol abuse
- Patients who participate in any other clinical study investigating drugs or medical devices
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Praxis am Stadtpark
Ahlen, North Rhine-Westphalia, 59227
Universitäres Herz- und Gefäßzentrum, Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20251
United Kingdom1 site
Pinderfields Hospital
Wakefield, West Yorkshire, WF1 3DG
About this study
Official title: Post Market Clinical Follow up Study to Examine Clinical Performance of the Debridement Pad Cutimed DebriClean
Documentation of the performance and safety of the debridement pad Cutimed DebriClean in daily clinical practice
Read the detailed description
60 subjects with superficial wounds in need of debridement will undergo mechanical debridement with the study product.
Per subject, one application of the study product will be documented including photo documentation of the wound and evaluation of the wound bed condition and wound size before and after the debridement.
- Conditions
- Wound
- Being tested
- mechanical debridement
- Keywords
- Debridement
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical debridementDevice
The mechanical debridement is performed using the debridement pad Cutimed DebriClean. After the pad is moistened with wound-cleansing solution, the wound is cleaned using circular movements while applying gentle pressure.
| Study group | Role | What they receive |
|---|---|---|
| Group treated with study product | Subjects will undergo one mechanical debridement procedure with Cutimed DebriClean Receives: Device: mechanical debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of wound bed condition from baseline to assessment immediately after the mechanical debridement (within one study visit)
Percentage of wound coverage with debris/necrosis/slough Wound edge cleaned smooth Surrounding skin cleaned e.g. from skin flakes
Measured: assessed immediately before and immediately after the mechanical debridement (within one study visit)
Secondary outcomes (6)
Wound size after and before wound debridement
Wound length and wound width are measured using a wound ruler. Wound size is calculated using the formula A = length x width x π/4.
Measured: assessed immediately before and immediately after the mechanical debridement (within one study visit)
Time needed for the debridement procedure
Time from start to completion of the debridement procedure in minutes
Measured: Time is measured during the debridement procedure
Debris/necrosis/slough absorbed by test product
assessed by the investigator (five categories)
Measured: assessed immediately after the mechanical debridement
Structural integrity of the test product
assessed by the investigator (e.g. change in shape, loosening of fibers, …)
Measured: assessed immediately after the mechanical debridement
Pain during the debridement procedure
Patient reported pain assessed using a visual analogue scale. If applicable, duration of pain is documented.
Measured: assessed immediately after the debridement procedure
Adverse device effects
Discomfort, pressure, burning sensation, bleeding, and irritation of the periwound skin during or after the mechanical debridement, other adverse device effects swelling; redness
Measured: assessed immediately after the debridement procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start27 Apr 2021
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- BSN Medical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leanne Atkin, Dr., Principal investigator, The University of Huddersfield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731753
- Sponsor's protocol ID
- BSN-C2533
- Status last verified
- Feb 2022
- First submitted
- 18 Jan 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared. Data are needed for post market clinical follow up.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow up Study to Examine Clinical Performance of the Debridement Pad Cutimed DebriClean
- ClinicalTrials.gov ID
- NCT04731753
- Acronym / sponsor ID
- BSN-C2533
- Conditions
- Wound
- Keywords
- Debridement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- BSN Medical GmbHIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 1 Feb 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.
Documentation of the performance and safety of the debridement pad Cutimed DebriClean in daily clinical practice
Detailed description
60 subjects with superficial wounds in need of debridement will undergo mechanical debridement with the study product.
Per subject, one application of the study product will be documented including photo documentation of the wound and evaluation of the wound bed condition and wound size before and after the debridement.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group treated with study product | – | Device: mechanical debridementSubjects will undergo one mechanical debridement procedure with Cutimed DebriClean |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with superficial wounds in need of debridement, for example diabetic ulcers, venous and arterial ulcers, pressure sores, postoperative wounds and wounds healing by secondary intention, superficial burns, the absorption of exudate, slough and dry skin flakes.
Key inclusion criteria (6 listed)
- Male or female subjects aged 18 years or older with full legal competence
- Signed informed consent
- Subjects with wounds in need of debridement, especially diabetic ulcers, venous and arterial ulcers, pressure sores, postoperative wounds and wounds healing by secondary intention, superficial burns
- Superficial wound
- Minimum 30 % of the wound is covered by debris, necrosis or slough
Key exclusion criteria (6 listed)
- Subjects not willing to participate or to attend the scheduled study visit
- Known sensitivity or allergy to the product components
- Severe pain or hyperaesthesia in the wound area
- Patients who are pregnant or lactating
- Drug abuse or alcohol abuse
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 |
|---|---|---|
| mechanical debridementThe mechanical debridement is performed using the debridement pad Cutimed DebriClean. After the pad is moistened with wound-cleansing solution, the wound is cleaned using circular movements while applying gentle pressure. | Device | Group treated with study product |
Primary outcome
Change of wound bed condition from baseline to assessment immediately after the mechanical debridement (within one study visit)
Time frame: assessed immediately before and immediately after the mechanical debridement (within one study visit)
Percentage of wound coverage with debris/necrosis/slough Wound edge cleaned smooth Surrounding skin cleaned e.g. from skin flakes
6 secondary outcomes
Wound size after and before wound debridement
Time frame: assessed immediately before and immediately after the mechanical debridement (within one study visit)
Time needed for the debridement procedure
Time frame: Time is measured during the debridement procedure
Debris/necrosis/slough absorbed by test product
Time frame: assessed immediately after the mechanical debridement
Structural integrity of the test product
Time frame: assessed immediately after the mechanical debridement
Pain during the debridement procedure
Time frame: assessed immediately after the debridement procedure
Adverse device effects
Time frame: assessed immediately after the debridement procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No. No IPD will be shared. Data are needed for post market clinical follow up.
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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.
Leanne Atkin, Dr. principal investigator
The University of Huddersfield
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound, run by BSN Medical GmbH at 3 sites in 2 countries.
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 6 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: finished, as of the sponsor's last update on 20 Jul 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, United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of wound bed condition from baseline to assessment immediately after the mechanical debridement (within one study visit) (time frame: assessed immediately before and immediately after the mechanical debridement (within one study visit)). 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 20 Jul 2022.