PMCF Study to Examine the Debridement Pad Cutimed DebriClean

NCT04731753 | Completed

• 1 other identifier: BSN-C2533
• Study Type: observational
• Target: 62
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Wound

Keywords

Debridement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Wound size after and before wound debridement

  assessed immediately before and immediately after the mechanical debridement (within one study visit)

• Time needed for the debridement procedure

  Time is measured during the debridement procedure

• Debris/necrosis/slough absorbed by test product

  assessed immediately after the mechanical debridement

• Structural integrity of the test product

  assessed immediately after the mechanical debridement

• Pain during the debridement procedure

  assessed immediately after the debridement procedure

Study Arms (1)

Group treated with study product

Subjects will undergo one mechanical debridement procedure with Cutimed DebriClean

Device: mechanical debridement

Interventions

mechanical debridement 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.

Group treated with study product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BSN Medical GmbH: lead

Study Sites (3)

Praxis am Stadtpark

Ahlen, North Rhine-Westphalia, 59227, Germany

Location

Universitäres Herz- und Gefäßzentrum, Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

Pinderfields Hospital

Wakefield, West Yorkshire, WF1 3DG, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Leanne Atkin, Dr.

  The University of Huddersfield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: February 1, 2021
• Study Start: April 27, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); DE (2)