PMCF Study to Examine the Debridement Pad Cutimed DebriClean

Completed

• Conditions: Wound
• Interventions: Device: mechanical debridement

• Registration Number: NCT04731753
• Lead Sponsor: BSN Medical GmbH

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.

Study Timeline

• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-02-01
• Study Start: 2021-04-27
• Status Verified: 2022-02
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group treated with study product	mechanical debridement	Subjects will undergo one mechanical debridement procedure with Cutimed DebriClean

Primary Outcome Measures

Name	Time	Method
Change of wound bed condition from baseline to assessment immediately after the mechanical debridement (within one study visit)	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

Secondary Outcome Measures

Name	Time	Method
Wound size after and before wound debridement	assessed immediately before and immediately after the mechanical debridement (within one study visit)	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.
Adverse device effects	assessed immediately after the debridement procedure	Discomfort, pressure, burning sensation, bleeding, and irritation of the periwound skin during or after the mechanical debridement, other adverse device effects swelling; redness
Debris/necrosis/slough absorbed by test product	assessed immediately after the mechanical debridement	assessed by the investigator (five categories)
Structural integrity of the test product	assessed immediately after the mechanical debridement	assessed by the investigator (e.g. change in shape, loosening of fibers, ...)
Pain during the debridement procedure	assessed immediately after the debridement procedure	Patient reported pain assessed using a visual analogue scale. If applicable, duration of pain is documented.
Time needed for the debridement procedure	Time is measured during the debridement procedure	Time from start to completion of the debridement procedure in minutes

Trial Locations

Locations (3)

Pinderfields Hospital; 🇬🇧 Wakefield, West Yorkshire, United Kingdom

Universitäres Herz- und Gefäßzentrum, Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Praxis am Stadtpark; 🇩🇪 Ahlen, Nordrhein-Westfalen, Germany