PMCF Study to Examine the Debridement Pad Cutimed DebriClean

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

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

Study Overview

• Status: Completed
• Conditions: Wound
• Intervention / Treatment: Device: mechanical debridement

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 Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20251
    • Universitäres Herz- und Gefäßzentrum, Universitätsklinikum Hamburg-Eppendorf
  • Nordrhein-Westfalen
    • Ahlen, Nordrhein-Westfalen, Germany, 59227
      • Praxis am Stadtpark
• United Kingdom
  • West Yorkshire
    • Wakefield, West Yorkshire, United Kingdom, WF1 3DG
      • Pinderfields Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with superficial wounds in need of debridement, for example diabetic ulcers, venous and arterial ulcers, pressure sores, postoperative wounds and wounds healing by secondary intention, superficial burns, the absorption of exudate, slough and dry skin flakes.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group treated with study product; Subjects will undergo one mechanical debridement procedure with Cutimed DebriClean	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: BSN Medical GmbH
• Investigators: Principal Investigator: Leanne Atkin, Dr., The University of Huddersfield

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Debridement
• Other Study ID Numbers: BSN-C2533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD will be shared. Data are needed for post market clinical follow up.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No