PMCF Study to Examine the Debridement Pad Cutimed DebriClean

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-27

Study Completion Date

2022-05-30

Brief Summary

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

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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.

Conditions

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Wound

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group treated with study product

Subjects will undergo one mechanical debridement procedure with Cutimed DebriClean

mechanical debridement

Intervention Type DEVICE

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.

Interventions

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mechanical debridement

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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No