PMCF Study to Examine the Debridement Pad Cutimed DebriClean

• Sponsor: BSN Medical GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04731753
• Collaborator: (none)
• Enrollment: 62
• Locations: 3
• Actual Duration (Months): 13.1
• Patients Per Site: 20.7
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Wound	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 Design

• Study Type: Observational
• Actual Enrollment: 62 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Post Market Clinical Follow up Study to Examine Clinical Performance of the Debridement Pad Cutimed DebriClean
• Actual Study Start Date: Apr 27, 2021
• Actual Primary Completion Date: May 30, 2022
• Actual Study Completion Date: May 30, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. Time needed for the debridement procedure [Time is measured during the debridement procedure]

   Time from start to completion of the debridement procedure in minutes

3. Debris/necrosis/slough absorbed by test product [assessed immediately after the mechanical debridement]

   assessed by the investigator (five categories)

4. Structural integrity of the test product [assessed immediately after the mechanical debridement]

   assessed by the investigator (e.g. change in shape, loosening of fibers, …)

5. 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.

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Praxis am Stadtpark	Ahlen	Nordrhein-Westfalen	Germany	59227
2	Universitäres Herz- und Gefäßzentrum, Universitätsklinikum Hamburg-Eppendorf	Hamburg		Germany	20251
3	Pinderfields Hospital	Wakefield	West Yorkshire	United Kingdom	WF1 3DG

Sponsors and Collaborators

• BSN Medical GmbH

Investigators

• Principal Investigator: Leanne Atkin, Dr., The University of Huddersfield

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BSN Medical GmbH
• ClinicalTrials.gov Identifier: NCT04731753
• Other Study ID Numbers: BSN-C2533
• First Posted: Feb 1, 2021
• Last Update Posted: Jul 20, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by BSN Medical GmbH: Debridement

Study Results

No Results Posted as of Jul 20, 2022