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

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.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* mentally and physically able to participate in study
* written informed consent to participate in the study
* Diagnosed wound indicated for treatment with Cutimed® Gelling Fiber for 4 weeks (except for internal body cavities and closed wounds)
* Subjects with more than one ulcer are eligible for inclusion, however only one ulcer per subject will be included in the study.

Exclusion Criteria:

* Sensitivity to or allergic reaction to the dressing or its components
* Participation in any other clinical study investigating drugs or medical devices
* Subjects presenting with wounds including internal body cavities or closed wounds
* Alcohol and drug addiction
* Pregnant or breast-feeding subjects
* Underlying diseases are not treated according to respective country-specific guidelines