PMCF Study to Examine the Debridement Pad Cutimed DebriClean

BSN Medical GmbH62 enrolled

Overview

Documentation of the performance and safety of the debridement pad Cutimed DebriClean in daily clinical practice

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 Type

OBSERVATIONAL

Enrollment

Conditions

Wound

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Praxis am Stadtpark

Ahlen, North Rhine-Westphalia, Germany

Universitäres Herz- und Gefäßzentrum, Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Pinderfields Hospital

Wakefield, West Yorkshire, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: assessed immediately before and immediately after the mechanical debridement (within one study visit)

Secondary Outcomes

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.

Time frame: 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

Time frame: Time is measured during the debridement procedure

Debris/necrosis/slough absorbed by test product

assessed by the investigator (five categories)

Time frame: assessed immediately after the mechanical debridement

Structural integrity of the test product

assessed by the investigator (e.g. change in shape, loosening of fibers, …)

Time frame: 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.

Time frame: assessed immediately after the debridement procedure

Adverse device effects

Data from ClinicalTrials.gov

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