PMCF Study to Examine the Debridement Pad Cutimed DebriClean

Study Overview
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Brief Summary
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Documentation of the performance and safety of the debridement pad Cutimed DebriClean in daily clinical practice

Detailed Description
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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.

Official Title
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Post Market Clinical Follow up Study to Examine Clinical Performance of the Debridement Pad Cutimed DebriClean

Conditions
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Wound

Intervention / Treatment
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* Device: mechanical debridement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group treated with study product<br>Subjects will undergo one mechanical debridement procedure with Cutimed DebriClean | Device: mechanical debridement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | assessed immediately before and immediately after the mechanical debridement (within one study visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 is measured during the debridement procedure | 
| Debris/necrosis/slough absorbed by test product | assessed by the investigator (five categories) | assessed immediately after the mechanical debridement | 
| Structural integrity of the test product | assessed by the investigator (e.g. change in shape, loosening of fibers, …) | 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. | 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 | assessed immediately after the debridement procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Debridement