Skip to main content
OpenTrials
Completed

NCT Number: NCT04731753

PMCF Study to Examine the Debridement Pad Cutimed DebriClean

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Praxis am Stadtpark, Ahlen, North Rhine-Westphalia, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Wound size after and before wound debridement

    Time frame: 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 frame: 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

    Time frame: assessed immediately after the mechanical debridement

    assessed by the investigator (five categories)

  4. Structural integrity of the test product

    Time frame: assessed immediately after the mechanical debridement

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

  5. Pain during the debridement procedure

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

BSN Medical GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2021
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.