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Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice

NCT05148390 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2024-02-21

No results posted yet for this study

Summary

This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e. within its intended purpose and without any additional invasive or stressing examinations for the patients.

Up to 36 adult patients with wounds suitable to be treated with the medical device and meeting the inclusion/exclusion criteria will be enrolled at two participating German sites.

During 5 on-site visits within 28 days routine weekly dressing changes the Health Care Professional will examine the wound and will perform required wound care and dressing changes. Pictures of the wound with and without dressing will be taken at each visit and used for automatic analysis. The subjects will be asked to rate their general wound pain and the pain perceived during dressing changes. A wound-related quality of life questionnaire will be presented to the subjects twice and the subject and HCP will rate their safisfaction with the product.

Conditions

  • Leg Ulcer
  • Diabetic Foot Ulcer
  • Pressure Ulcer
  • Surgical Wound
  • Abrasion
  • Laceration
  • Burn, Partial Thickness
  • Oncology Wound

Interventions

DEVICE

Cutimed® Gelling Fiber

application of dressing

Sponsors & Collaborators

  • BSN Medical GmbH

    lead INDUSTRY

Principal Investigators

  • Arne Böhling, Dr. · BSN Medical GmbH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-24
Primary Completion
2023-07-26
Completion
2023-07-26

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05148390 on ClinicalTrials.gov