PMCF Study to Examine the Debridement Pad Cutimed DebriClean

Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04731753
• Other study ID #: BSN-C2533
• Status: Completed
• Start date: April 27, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: February 2022
• Source: BSN Medical GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Germany	Praxis am Stadtpark	Ahlen	Nordrhein-Westfalen
Germany	Universitäres Herz- und Gefäßzentrum, Universitätsklinikum Hamburg-Eppendorf	Hamburg
United Kingdom	Pinderfields Hospital	Wakefield	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
BSN Medical GmbH

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 p/4.	assessed immediately before and immediately after the mechanical debridement (within one study visit)
Secondary	Time needed for the debridement procedure	Time from start to completion of the debridement procedure in minutes	Time is measured during the debridement procedure
Secondary	Debris/necrosis/slough absorbed by test product	assessed by the investigator (five categories)	assessed immediately after the mechanical debridement
Secondary	Structural integrity of the test product	assessed by the investigator (e.g. change in shape, loosening of fibers, …)	assessed immediately after the mechanical debridement
Secondary	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
Secondary	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