Clinical trial NCT04731753: PMCF Study to Examine the Debridement Pad Cutimed DebriClean
Official title: Post Market Clinical Follow up Study to Examine Clinical Performance of the Debridement Pad Cutimed DebriClean
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound
Keywords: Debridement
Lead sponsor: BSN Medical GmbH
Sponsor class: INDUSTRY
First posted: 2021-02-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of wound bed condition from baseline to assessment immediately after the mechanical debridement (within one study visit)
timeFrame: assessed immediately before and immediately after the mechanical debridement (within one study visit)
Secondary outcomes:
measure: Wound size after and before wound debridement
timeFrame: assessed immediately before and immediately after the mechanical debridement (within one study visit)
measure: Time needed for the debridement procedure
timeFrame: Time is measured during the debridement procedure
measure: Debris/necrosis/slough absorbed by test product
timeFrame: assessed immediately after the mechanical debridement
measure: Structural integrity of the test product
timeFrame: assessed immediately after the mechanical debridement
measure: Pain during the debridement procedure
timeFrame: assessed immediately after the debridement procedure
measure: Adverse device effects
timeFrame: assessed immediately after the debridement procedure
Other outcomes:
Locations:
city: Ahlen
country: Germany
facility: Praxis am Stadtpark
state: Nordrhein-Westfalen
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum, Universitätsklinikum Hamburg-Eppendorf
city: Wakefield
country: United Kingdom
facility: Pinderfields Hospital
state: West Yorkshire
Study officials:
affiliation: The University of Huddersfield
name: Leanne Atkin, Dr.
role: PRINCIPAL_INVESTIGATOR
References: